<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03774342</url>
  </required_header>
  <id_info>
    <org_study_id>2018226</org_study_id>
    <secondary_id>2018/226</secondary_id>
    <nct_id>NCT03774342</nct_id>
  </id_info>
  <brief_title>The Influence of Cognitive Decline on Quality of Life After Coronary Bypass</brief_title>
  <official_title>The Influence of Cognitive Decline on Quality of Life After Coronary Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During the last decades improvements in operative techniques and perioperative care have led&#xD;
      to a steady decline in mortality after cardiac surgery. Good survival rates have been shown&#xD;
      repeatedly although elderly patients have an increased risk for prolonged hospital stay and&#xD;
      postoperative complications such as neurological and pulmonary problems. Post-operative&#xD;
      cognitive decline (POCD) is common after cardiac surgery and although this cognitive decline&#xD;
      can be subtle, in elderly vulnerable patients even a small decline can have important&#xD;
      consequences such as a decreased quality of life and loss of independence. Recent studies&#xD;
      among patients after coronary artery bypass grafting (CABG) found that the incidence of POCD&#xD;
      varied between 30-60% depending on cognitive tests, time of assessment and patient&#xD;
      populations.&#xD;
&#xD;
      Cognitive and physical impairment frequently co-occur in older people. The association&#xD;
      between cognitive impairment and functional disability has been investigated in several&#xD;
      studies, which demonstrated that cognitive decline is associated with functional disability,&#xD;
      also after cardiac surgery. One method for estimation of patients' physical performance is to&#xD;
      evaluate sarcopenia. Sarcopenia is defined as a syndrome characterised by progressive and&#xD;
      generalised loss of skeletal muscle mass and strength, leading to an increased risk of&#xD;
      adverse outcomes such as physical disability, poor quality of life and death. Data on the&#xD;
      prevalence of sarcopenia in community-dwelling residents or nursing-homes are widely&#xD;
      available, but little is known on (elderly) hospitalized patients after cardiac surgery. The&#xD;
      aim of this study is to evaluate the association between post-operative cognitive decline,&#xD;
      quality of life (QoL) and sarcopenia in adult patients after coronary artery bypass grafting.&#xD;
      The investigators hypothesize that a decreased postoperative QoL is mainly explained by POCD,&#xD;
      therefore the primary research question of this study is: What is the influence of&#xD;
      post-operative cognitive decline on QoL after CABG? The secondary research question is: Is&#xD;
      there an association between postoperative sarcopenia and a decreased postoperative QoL?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design:&#xD;
&#xD;
      The investigators will conduct a prospective observational cohort study to evaluate QoL,&#xD;
      cognitive decline and sarcopenia in adult patients after coronary artery bypass grafting. The&#xD;
      investigators hypothesize that cognitive decline is more associated with QoL than sarcopenia.&#xD;
      QoL will be measured using the RAND-36 questionnaire. Cognitive functioning will be measured&#xD;
      using several cognitive tests and sarcopenia will be evaluated by measuring muscle mass and&#xD;
      muscle strength. The investigators will explore different subgroups according to age&#xD;
      including elderly patients (e.g. patients aged 80 years or older at the time of surgery),&#xD;
      according to a prolonged stay at the Intensive Care Unit (&gt;24 hours) and according to&#xD;
      comorbidities (i.e. diabetes, pulmonary disease, renal failure).&#xD;
&#xD;
      Data collection method:&#xD;
&#xD;
      Routinely, patients planned for CABG are admitted to the cardiothoracic ward one day before&#xD;
      surgery. On the day of admittance (one day before surgery) patients will be asked to perform&#xD;
      a simple brief battery of 4 computerized tests of cognitive function. At the same time,&#xD;
      muscle mass will be assessed using a bioelectrical impedance instrument (BIA) and muscle&#xD;
      strength will be assessed using a handgrip strength device. Patients wil also be asked to&#xD;
      fill-in a quality of life questionnaire (RAND-36 health survey). Three days after surgery&#xD;
      assessments of cognitive functioning, muscle mass and muscle strength will be repeated. Six&#xD;
      months after surgery patients will be visited at home where cognitive functioning, muscle&#xD;
      strength, muscle mass and QoL will be reassessed.&#xD;
&#xD;
      Study parameters:&#xD;
&#xD;
        1. The primary outcome will be quality of life assessed using the RAND-36 version 2&#xD;
           questionnaire. The questionnaire is widely validated, has a good reliability and&#xD;
           includes eight health domains: physical functioning, social functioning, role&#xD;
           limitations due to physical health problems, role limitations due to emotional problems,&#xD;
           mental health, vitality, pain and general health perception. Outcomes at each dimension&#xD;
           will be defined on a scale between 0 and 100; a higher score is equivalent to better&#xD;
           health.&#xD;
&#xD;
        2. Cognitive function will be assessed using the brief computerised cognitive test battery&#xD;
           (cogstate Ltd, Melbourne, Vic., Australia). This set of tests consists of the detection&#xD;
           task, the identification task, the one card learning task and the one back task&#xD;
           assessing psychomotor speed, selective attention, visual learning and working memory,&#xD;
           respectively. For each postoperative cognitive test, a standardized change in Z-score&#xD;
           will be calculated from the difference between the postoperative and baseline score. Of&#xD;
           all individual tests the standardized Z-scores will be summed up to generate a composite&#xD;
           Z-score. POCD is defined as a Z-score &lt; -2 in two or more individual tasks or a&#xD;
           composite Z-score of &lt; -2.&#xD;
&#xD;
        3. To detect sarcopenia the European Working Group on Sarcopenia in Older People (EWGSOP)&#xD;
           recommends measurement of both the presence of low muscle mass and low muscle function.&#xD;
           Bioelectrical impedance analysis (BIA) can be used for estimation of muscle mass and&#xD;
           assessment of handgrip strength can be used for estimation of muscle function.&#xD;
&#xD;
             -  Bio-impedance analysis: BIA estimates the volume of fat and lean body mass. For the&#xD;
                calculation of muscle mass we will use the measurements Resistance (RZ), Reactance&#xD;
                (Xc) and Phase Angle (Pa) obtained with BIA. These values will be computed by&#xD;
                empirically formulated equations based on healthy people with a hydration of the&#xD;
                lean body mass around 73%, leading to values for muscle mass (MM), body cell mass&#xD;
                (BCM), fat mass (FM) and fat free mas (FFM). Bioelectrical impedance analysis will&#xD;
                be performed using a BIA 101 Anniversary edition (AKERN, Florence, Italy). Cut-off&#xD;
                values based on normative populations of men and women ≥ 60 years and recommended&#xD;
                by the EWGSOP will be used as reference for our study population.&#xD;
&#xD;
             -  Handgrip strength: Muscle strength of the upper extremities will be tested with a&#xD;
                hand dynameter measured using the dominant hand. To become familiar with the test,&#xD;
                patients will be allowed to perform one practice-test, and then three consecutive&#xD;
                tests will be carried out with one minute rest between tests. Only the highest&#xD;
                score of the handgrip test will be used for analysis; results will be compared with&#xD;
                the reference values recommended by the EWGSOP guidelines.&#xD;
&#xD;
      Additional data:&#xD;
&#xD;
      Additionally, routinely collected variables such as prognostic factors at baseline, data on&#xD;
      the surgical procedure and the occurrence of postoperative complications will be recorded as&#xD;
      well. Baseline demographic data will include age, gender, body mass index, education level,&#xD;
      log EuroSCORE I and co-morbidity such as diabetes (oral therapy or insulin dependent&#xD;
      diabetes), pulmonary disease (prolonged use of steroids or other lung medication), arterial&#xD;
      vascular disease (peripheral or abdominal vascular pathology or operation due to arterial&#xD;
      vascular disease, renal disease (a reduced renal function prior to surgery with an estimated&#xD;
      Glomerular Filtration rate (eGFR) &lt;60 ml/min/1.73 m2) and ventricular function (left&#xD;
      ventricular ejection fraction: good &gt;50%, moderate 30-50% or poor &lt;30%). The log EuroSCORE I&#xD;
      is a widely used risk stratification system for adult cardiac surgery patients which&#xD;
      estimates a mortality risk for each individual patient. Data on surgical procedures will be&#xD;
      obtained and include the number of grafts and use of cardiopulmonary bypass.&#xD;
&#xD;
      Postoperative complications include:&#xD;
&#xD;
        -  Delirium during hospital admittance defined as:&#xD;
&#xD;
             1. A delirium observation scale score ≥ 3 at hospital ward and/or&#xD;
&#xD;
             2. A positive confusion assessment method (CAM)-ICU score at the ICU and/or&#xD;
&#xD;
             3. Diagnosis confirmed by a psychiatrist or geriatrist according to the Diagnostic and&#xD;
                Statistical Manual (DSM)-IV criteria&#xD;
&#xD;
        -  Myocardial infarction (MI) in the postoperative period. Myocardial infarction associated&#xD;
           with CABG (within 48 hours after CABG) is arbitrarily defined by elevation of cardiac&#xD;
           biomarker values &gt;10 x 99th percentile upper reference limit (URL) in patients with&#xD;
           normal baseline cardiac troponin values. In addition, either (I) new pathological Q&#xD;
           waves or new LBBB, or (II) angiographic documented new graft or new native coronary&#xD;
           artery occlusion, or (III) imaging evidence of new loss of viable myocardium or new&#xD;
           regional wall motion abnormality. After 48 hours, the standard definition of myocardial&#xD;
           infarction is appropriate. The following criteria meets the diagnosis for MI: detection&#xD;
           of a rise and/or fall of cardiac biomarker values, preferably cardiac troponin, with at&#xD;
           least one value above the 99th percentile URL and in addition, either (I) symptoms of&#xD;
           ischaemia, or (II) new or presumed new significant ST-segment-T wave (ST-T) changes or&#xD;
           new left bundle branch block (LBBB), or (III) development of pathological Q waves in the&#xD;
           ECG, or (IV) imaging evidence of new loss of viable myocardium or new regional wall&#xD;
           motion abnormality or identification of an intracoronary thrombus by angiography or&#xD;
           autopsy&#xD;
&#xD;
        -  Surgical re-exploration within 30 days after surgery: thoracotomy due to bleeding,&#xD;
           cardiac tamponade or graft failure&#xD;
&#xD;
        -  Deep wound infection within 30 days after surgery: when deeper tissues are affected&#xD;
           (muscle, sternum and mediastinum) and one or more of the following three criteria are&#xD;
           met:&#xD;
&#xD;
             1. surgical drainage or refixation&#xD;
&#xD;
             2. an organism is isolated from culture of mediastina tissue or fluid&#xD;
&#xD;
             3. antibiotic treatment because of a sternal wound&#xD;
&#xD;
        -  Stroke: an acute neurological event within 72 hours after surgery with focal signs and&#xD;
           symptoms and without evidence supporting any alternative explanation. Diagnoses of&#xD;
           stroke requires confirmation by a neurologist&#xD;
&#xD;
        -  Renal failure within 30 days after surgery when one or more of the following criteria&#xD;
           are met:&#xD;
&#xD;
             1. renal replacement therapy (dialysis or CVVH) which was not present preoperatively&#xD;
&#xD;
             2. highest postoperative creatinine level &gt; 177 μmol/L and a doubling of the&#xD;
                preoperative value (the preoperative creatinine value is the value on which the&#xD;
                EuroSCORE is calculated)&#xD;
&#xD;
      Additional outcomes will be, stay at the Intensive Care Unit (in hours) and discharge&#xD;
      destination (i.e. home, nursing home or other healthcare facility).&#xD;
&#xD;
      Data management:&#xD;
&#xD;
      Data will be recorded using OpenClinica and transferred for analysis using Statistical&#xD;
      Package for the Social Sciences (SPSS) version 22 (IBM, Chicago, IL). All study subjects will&#xD;
      receive a unique study subject identification (ID). Only a researcher with &quot;study director&quot;&#xD;
      account properties in OpenClinica will be able to link study subject ID to patient number.&#xD;
&#xD;
      Sample size assessment:&#xD;
&#xD;
      The sample size calculation is based on the hypothetical association between postoperative&#xD;
      cognitive decline and QoL. Cognitive decline is assumed to be the independent variable and&#xD;
      quality of life as the dependent variable. Data from a previous study among CABG-patients&#xD;
      demonstrated POCD in 26% of the included patients at three months after surgery. POCD was&#xD;
      defined as a Z-score &lt; -2 in two or more individual tasks, or a composite Z-score of &lt; -2,&#xD;
      and the standard deviation (SD) for POCD in this study was 7.4. Another study on assessment&#xD;
      of QoL after cardiac events including 6384 patients reported standard deviations of 10.3 and&#xD;
      11.0. With a minimal clinical important difference set at 5 points for change in QoL (e.g.&#xD;
      the difference between the postoperative and baseline score), a sample size of 123 patients&#xD;
      wil be required for a two-tailed test at an α of 0.05 and power of 80% to find an association&#xD;
      between POCD and QoL. The investigators plan to include 140 patients to account for missing&#xD;
      data. The inclusion will start in October 2018 and is expected to be completed by the end of&#xD;
      July 2019.&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      Characteristics of patients will be presented as proportions (with percentages) for&#xD;
      dichotomous variables and as means (with standard deviations) or medians (with interquartile&#xD;
      ranges) for continuous variables depending on normality. Differences between baseline and 3&#xD;
      days and 6 months follow-up of QoL, POCD and sarcopenia will be evaluated using paired&#xD;
      t-tests or Wilcoxon signed rank test when appropriate.&#xD;
&#xD;
      Linear regression will be used to evaluate the association between POCD and change in QoL.&#xD;
      First, unadjusted univariate regression analyses of POCD, sarcopenia and potential&#xD;
      confounders will be conducted. The following comorbidities will be considered as potential&#xD;
      confounders: arterial vascular disease, BMI, renal disease, ventricular function.&#xD;
      Additionally, the following postoperative complications will also be evaluated as potential&#xD;
      confounders: delirium, stroke and surgical re-exploration.&#xD;
&#xD;
      Multivariable linear regression analysis will be used to evaluate the association of&#xD;
      cognitive decline with sarcopenia as covariate, while adjusting for confounding factors. Age&#xD;
      will be forced into the multivariable model as it is considered a covariate based on&#xD;
      literature, and sarcopenia measured by muscle strength (handgrip test) and muscle mass (BIA)&#xD;
      will also be forced into the model as these will also be considered covariates. We will use a&#xD;
      p &lt; 0.25 threshold for inclusion of potential confounding variables in the multivariable&#xD;
      model, which will be constructed using forward stepwise regression by adding blocks of&#xD;
      variables. The multivariable model with POCD as independent variable and QoL as dependent&#xD;
      variable will be adjusted for sarcopenia, as covariates. Assumptions will be checked using&#xD;
      the appropriate tests. All tests will be performed two-sided and variables with p-values of&#xD;
      less than 0.05 will be considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>at baseline (one day before surgery) and 6 months after surgery</time_frame>
    <description>Quality of life will be assessed using the RAND-36 version 2 questionnaire, a widely validated questionnaire including eight health domains; physical functioning, social functioning, role limitations due to physical health problems, role limitations due to emotional problems, mental health, vitality, pain and general health perception. Outcomes at each domain will be defined on a scale from a minimum score of 0 to a maximum score of 100. A higher score is equivalent to a better health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in cognitive functioning</measure>
    <time_frame>Two sets of cognitive tests will be performed on the day before surgery; one practice test and a second test that will be used as a baseline test. Follow-up tests will be performed at 3 days and 6 months after surgery.</time_frame>
    <description>Cognitive function will be assessed using a set of computerised cognitive tests.This set of tests consists of the detection task, the identification task, the one card learning task and the one back task assessing psychomotor speed, selective attention, visual learning and working memory, respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in muscle strength</measure>
    <time_frame>All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery.</time_frame>
    <description>Assessment of handgrip strength using the Baseline LiTE Hydraulic Hand Dynamometer will be assessed for estimation of muscle function. To become familiar with the test, patients will be allowed to perform one practice-test, and then three consecutive tests will be carried out with one minute rest between tests. Only the highest score of the handgrip test will be used for analysis; strength is measured in kilograms and the testresults will be compared with the reference values recommended by the EWGSOP guidelines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in muscle mass</measure>
    <time_frame>All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery.</time_frame>
    <description>Bioelectrical impedance analysis (BIA) will be used for estimation of muscle mass. For the calculation of muscle mass the measurements Resistance, Reactance and Phase Angle will be obtained with BIA. These values will be computed by empirically formulated equations based on healthy people leading to values for muscle mass, body cell mass, fat mass and fat free mass. Cut-off values based on normative populations of men and women and recommended by the sarcopenia work group (EWGSOP) will be used as reference for the study population.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Coronary Artery Bypass</condition>
  <condition>Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>CABG-patients</arm_group_label>
    <description>We will study one group of patients all scheduled for a Coronary Artery Bypass Grafting-procedure. This observational study consists of one group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronary Artery Bypass Grafting</intervention_name>
    <description>Patients undergoing coronary artery bypass grafting</description>
    <arm_group_label>CABG-patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients undergoing elective coronary artery bypass grafting&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients scheduled for elective, isolated on-pump CABG&#xD;
&#xD;
          -  able to stand and walk independently&#xD;
&#xD;
          -  able to participate in the online screenings module for cognitive function to reduce&#xD;
             the amount of missing data for cognitive function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing neurological deficits&#xD;
&#xD;
          -  Psychiatric illness&#xD;
&#xD;
          -  previous cardiac surgery&#xD;
&#xD;
          -  pre-existing muscular diseases or missing extremities&#xD;
&#xD;
          -  presence of an Internal Cardioverter Defibrillator (ICD), assist device or pacemaker&#xD;
&#xD;
          -  large amounts of metal in or around the body&#xD;
&#xD;
          -  inability to read or understand Dutch instructions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimo A Mariani, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Iwan CC van der Horst, MD, PhD</last_name>
    <phone>+31 614698780</phone>
    <email>i.c.c.van.der.horst@umcg.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9700 RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Fredrike Blokzijl, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Willem Dieperink, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Frederik Keus, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michiel F Reneman, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
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    <PMID>25696472</PMID>
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    <PMID>11207462</PMID>
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    <citation>Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. Erratum In: Stroke. 2019 Aug;50(8):e239.</citation>
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  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>I.C.C. van der Horst</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Coronary artery bypass grafting</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Cognitive dysfunction</keyword>
  <keyword>Sarcopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03774342
org study id: 2018226
secondary id: 2018/226
nct id: NCT03774342
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During the last decades improvements in operative techniques and perioperative care have led
      to a steady decline in mortality after cardiac surgery. Good survival rates have been shown
      repeatedly although elderly patients have an increased risk for prolonged hospital stay and
      postoperative complications such as neurological and pulmonary problems. Post-operative
      cognitive decline (POCD) is common after cardiac surgery and although this cognitive decline
      can be subtle, in elderly vulnerable patients even a small decline can have important
      consequences such as a decreased quality of life and loss of independence. Recent studies
      among patients after coronary artery bypass grafting (CABG) found that the incidence of POCD
      varied between 30-60% depending on cognitive tests, time of assessment and patient
      populations.

      Cognitive and physical impairment frequently co-occur in older people. The association
      between cognitive impairment and functional disability has been investigated in several
      studies, which demonstrated that cognitive decline is associated with functional disability,
      also after cardiac surgery. One method for estimation of patients' physical performance is to
      evaluate sarcopenia. Sarcopenia is defined as a syndrome characterised by progressive and
      generalised loss of skeletal muscle mass and strength, leading to an increased risk of
      adverse outcomes such as physical disability, poor quality of life and death. Data on the
      prevalence of sarcopenia in community-dwelling residents or nursing-homes are widely
      available, but little is known on (elderly) hospitalized patients after cardiac surgery. The
      aim of this study is to evaluate the association between post-operative cognitive decline,
      quality of life (QoL) and sarcopenia in adult patients after coronary artery bypass grafting.
      The investigators hypothesize that a decreased postoperative QoL is mainly explained by POCD,
      therefore the primary research question of this study is: What is the influence of
      post-operative cognitive decline on QoL after CABG? The secondary research question is: Is
      there an association between postoperative sarcopenia and a decreased postoperative QoL?
Study design:

      The investigators will conduct a prospective observational cohort study to evaluate QoL,
      cognitive decline and sarcopenia in adult patients after coronary artery bypass grafting. The
      investigators hypothesize that cognitive decline is more associated with QoL than sarcopenia.
      QoL will be measured using the RAND-36 questionnaire. Cognitive functioning will be measured
      using several cognitive tests and sarcopenia will be evaluated by measuring muscle mass and
      muscle strength. The investigators will explore different subgroups according to age
      including elderly patients (e.g. patients aged 80 years or older at the time of surgery),
      according to a prolonged stay at the Intensive Care Unit (>24 hours) and according to
      comorbidities (i.e. diabetes, pulmonary disease, renal failure).

      Data collection method:

      Routinely, patients planned for CABG are admitted to the cardiothoracic ward one day before
      surgery. On the day of admittance (one day before surgery) patients will be asked to perform
      a simple brief battery of 4 computerized tests of cognitive function. At the same time,
      muscle mass will be assessed using a bioelectrical impedance instrument (BIA) and muscle
      strength will be assessed using a handgrip strength device. Patients wil also be asked to
      fill-in a quality of life questionnaire (RAND-36 health survey). Three days after surgery
      assessments of cognitive functioning, muscle mass and muscle strength will be repeated. Six
      months after surgery patients will be visited at home where cognitive functioning, muscle
      strength, muscle mass and QoL will be reassessed.

      Study parameters:

        1. The primary outcome will be quality of life assessed using the RAND-36 version 2
           questionnaire. The questionnaire is widely validated, has a good reliability and
           includes eight health domains: physical functioning, social functioning, role
           limitations due to physical health problems, role limitations due to emotional problems,
           mental health, vitality, pain and general health perception. Outcomes at each dimension
           will be defined on a scale between 0 and 100; a higher score is equivalent to better
           health.

        2. Cognitive function will be assessed using the brief computerised cognitive test battery
           (cogstate Ltd, Melbourne, Vic., Australia). This set of tests consists of the detection
           task, the identification task, the one card learning task and the one back task
           assessing psychomotor speed, selective attention, visual learning and working memory,
           respectively. For each postoperative cognitive test, a standardized change in Z-score
           will be calculated from the difference between the postoperative and baseline score. Of
           all individual tests the standardized Z-scores will be summed up to generate a composite
           Z-score. POCD is defined as a Z-score < -2 in two or more individual tasks or a
           composite Z-score of < -2.

        3. To detect sarcopenia the European Working Group on Sarcopenia in Older People (EWGSOP)
           recommends measurement of both the presence of low muscle mass and low muscle function.
           Bioelectrical impedance analysis (BIA) can be used for estimation of muscle mass and
           assessment of handgrip strength can be used for estimation of muscle function.

             -  Bio-impedance analysis: BIA estimates the volume of fat and lean body mass. For the
                calculation of muscle mass we will use the measurements Resistance (RZ), Reactance
                (Xc) and Phase Angle (Pa) obtained with BIA. These values will be computed by
                empirically formulated equations based on healthy people with a hydration of the
                lean body mass around 73%, leading to values for muscle mass (MM), body cell mass
                (BCM), fat mass (FM) and fat free mas (FFM). Bioelectrical impedance analysis will
                be performed using a BIA 101 Anniversary edition (AKERN, Florence, Italy). Cut-off
                values based on normative populations of men and women ≥ 60 years and recommended
                by the EWGSOP will be used as reference for our study population.

             -  Handgrip strength: Muscle strength of the upper extremities will be tested with a
                hand dynameter measured using the dominant hand. To become familiar with the test,
                patients will be allowed to perform one practice-test, and then three consecutive
                tests will be carried out with one minute rest between tests. Only the highest
                score of the handgrip test will be used for analysis; results will be compared with
                the reference values recommended by the EWGSOP guidelines.

      Additional data:

      Additionally, routinely collected variables such as prognostic factors at baseline, data on
      the surgical procedure and the occurrence of postoperative complications will be recorded as
      well. Baseline demographic data will include age, gender, body mass index, education level,
      log EuroSCORE I and co-morbidity such as diabetes (oral therapy or insulin dependent
      diabetes), pulmonary disease (prolonged use of steroids or other lung medication), arterial
      vascular disease (peripheral or abdominal vascular pathology or operation due to arterial
      vascular disease, renal disease (a reduced renal function prior to surgery with an estimated
      Glomerular Filtration rate (eGFR) <60 ml/min/1.73 m2) and ventricular function (left
      ventricular ejection fraction: good >50%, moderate 30-50% or poor <30%). The log EuroSCORE I
      is a widely used risk stratification system for adult cardiac surgery patients which
      estimates a mortality risk for each individual patient. Data on surgical procedures will be
      obtained and include the number of grafts and use of cardiopulmonary bypass.

      Postoperative complications include:

        -  Delirium during hospital admittance defined as:

             1. A delirium observation scale score ≥ 3 at hospital ward and/or

             2. A positive confusion assessment method (CAM)-ICU score at the ICU and/or

             3. Diagnosis confirmed by a psychiatrist or geriatrist according to the Diagnostic and
                Statistical Manual (DSM)-IV criteria

        -  Myocardial infarction (MI) in the postoperative period. Myocardial infarction associated
           with CABG (within 48 hours after CABG) is arbitrarily defined by elevation of cardiac
           biomarker values >10 x 99th percentile upper reference limit (URL) in patients with
           normal baseline cardiac troponin values. In addition, either (I) new pathological Q
           waves or new LBBB, or (II) angiographic documented new graft or new native coronary
           artery occlusion, or (III) imaging evidence of new loss of viable myocardium or new
           regional wall motion abnormality. After 48 hours, the standard definition of myocardial
           infarction is appropriate. The following criteria meets the diagnosis for MI: detection
           of a rise and/or fall of cardiac biomarker values, preferably cardiac troponin, with at
           least one value above the 99th percentile URL and in addition, either (I) symptoms of
           ischaemia, or (II) new or presumed new significant ST-segment-T wave (ST-T) changes or
           new left bundle branch block (LBBB), or (III) development of pathological Q waves in the
           ECG, or (IV) imaging evidence of new loss of viable myocardium or new regional wall
           motion abnormality or identification of an intracoronary thrombus by angiography or
           autopsy

        -  Surgical re-exploration within 30 days after surgery: thoracotomy due to bleeding,
           cardiac tamponade or graft failure

        -  Deep wound infection within 30 days after surgery: when deeper tissues are affected
           (muscle, sternum and mediastinum) and one or more of the following three criteria are
           met:

             1. surgical drainage or refixation

             2. an organism is isolated from culture of mediastina tissue or fluid

             3. antibiotic treatment because of a sternal wound

        -  Stroke: an acute neurological event within 72 hours after surgery with focal signs and
           symptoms and without evidence supporting any alternative explanation. Diagnoses of
           stroke requires confirmation by a neurologist

        -  Renal failure within 30 days after surgery when one or more of the following criteria
           are met:

             1. renal replacement therapy (dialysis or CVVH) which was not present preoperatively

             2. highest postoperative creatinine level > 177 μmol/L and a doubling of the
                preoperative value (the preoperative creatinine value is the value on which the
                EuroSCORE is calculated)

      Additional outcomes will be, stay at the Intensive Care Unit (in hours) and discharge
      destination (i.e. home, nursing home or other healthcare facility).

      Data management:

      Data will be recorded using OpenClinica and transferred for analysis using Statistical
      Package for the Social Sciences (SPSS) version 22 (IBM, Chicago, IL). All study subjects will
      receive a unique study subject identification (ID). Only a researcher with "study director"
      account properties in OpenClinica will be able to link study subject ID to patient number.

      Sample size assessment:

      The sample size calculation is based on the hypothetical association between postoperative
      cognitive decline and QoL. Cognitive decline is assumed to be the independent variable and
      quality of life as the dependent variable. Data from a previous study among CABG-patients
      demonstrated POCD in 26% of the included patients at three months after surgery. POCD was
      defined as a Z-score < -2 in two or more individual tasks, or a composite Z-score of < -2,
      and the standard deviation (SD) for POCD in this study was 7.4. Another study on assessment
      of QoL after cardiac events including 6384 patients reported standard deviations of 10.3 and
      11.0. With a minimal clinical important difference set at 5 points for change in QoL (e.g.
      the difference between the postoperative and baseline score), a sample size of 123 patients
      wil be required for a two-tailed test at an α of 0.05 and power of 80% to find an association
      between POCD and QoL. The investigators plan to include 140 patients to account for missing
      data. The inclusion will start in October 2018 and is expected to be completed by the end of
      July 2019.

      Data analysis:

      Characteristics of patients will be presented as proportions (with percentages) for
      dichotomous variables and as means (with standard deviations) or medians (with interquartile
      ranges) for continuous variables depending on normality. Differences between baseline and 3
      days and 6 months follow-up of QoL, POCD and sarcopenia will be evaluated using paired
      t-tests or Wilcoxon signed rank test when appropriate.

      Linear regression will be used to evaluate the association between POCD and change in QoL.
      First, unadjusted univariate regression analyses of POCD, sarcopenia and potential
      confounders will be conducted. The following comorbidities will be considered as potential
      confounders: arterial vascular disease, BMI, renal disease, ventricular function.
      Additionally, the following postoperative complications will also be evaluated as potential
      confounders: delirium, stroke and surgical re-exploration.

      Multivariable linear regression analysis will be used to evaluate the association of
      cognitive decline with sarcopenia as covariate, while adjusting for confounding factors. Age
      will be forced into the multivariable model as it is considered a covariate based on
      literature, and sarcopenia measured by muscle strength (handgrip test) and muscle mass (BIA)
      will also be forced into the model as these will also be considered covariates. We will use a
      p < 0.25 threshold for inclusion of potential confounding variables in the multivariable
      model, which will be constructed using forward stepwise regression by adding blocks of
      variables. The multivariable model with POCD as independent variable and QoL as dependent
      variable will be adjusted for sarcopenia, as covariates. Assumptions will be checked using
      the appropriate tests. All tests will be performed two-sided and variables with p-values of
      less than 0.05 will be considered statistically significant.
observational model: Cohort
time perspective: Prospective
measure: Change in quality of life
time frame: at baseline (one day before surgery) and 6 months after surgery
description: Quality of life will be assessed using the RAND-36 version 2 questionnaire, a widely validated questionnaire including eight health domains; physical functioning, social functioning, role limitations due to physical health problems, role limitations due to emotional problems, mental health, vitality, pain and general health perception. Outcomes at each domain will be defined on a scale from a minimum score of 0 to a maximum score of 100. A higher score is equivalent to a better health.
measure: Change in cognitive functioning
time frame: Two sets of cognitive tests will be performed on the day before surgery; one practice test and a second test that will be used as a baseline test. Follow-up tests will be performed at 3 days and 6 months after surgery.
description: Cognitive function will be assessed using a set of computerised cognitive tests.This set of tests consists of the detection task, the identification task, the one card learning task and the one back task assessing psychomotor speed, selective attention, visual learning and working memory, respectively.
measure: Change in muscle strength
time frame: All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery.
description: Assessment of handgrip strength using the Baseline LiTE Hydraulic Hand Dynamometer will be assessed for estimation of muscle function. To become familiar with the test, patients will be allowed to perform one practice-test, and then three consecutive tests will be carried out with one minute rest between tests. Only the highest score of the handgrip test will be used for analysis; strength is measured in kilograms and the testresults will be compared with the reference values recommended by the EWGSOP guidelines.
measure: Change in muscle mass
time frame: All tests will be performed on the day before surgery, three days after surgery and 6 months after surgery.
description: Bioelectrical impedance analysis (BIA) will be used for estimation of muscle mass. For the calculation of muscle mass the measurements Resistance, Reactance and Phase Angle will be obtained with BIA. These values will be computed by empirically formulated equations based on healthy people leading to values for muscle mass, body cell mass, fat mass and fat free mass. Cut-off values based on normative populations of men and women and recommended by the sarcopenia work group (EWGSOP) will be used as reference for the study population.
arm group label: CABG-patients
description: We will study one group of patients all scheduled for a Coronary Artery Bypass Grafting-procedure. This observational study consists of one group.
intervention type: Procedure
intervention name: Coronary Artery Bypass Grafting
description: Patients undergoing coronary artery bypass grafting
arm group label: CABG-patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Massimo A Mariani, MD, PhD
role: Study Chair
affiliation: University Medical Center Groningen
last name: Iwan CC van der Horst, MD, PhD
phone: +31 614698780
email: i.c.c.van.der.horst@umcg.nl
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
country: Netherlands
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responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: I.C.C. van der Horst
investigator title: Associate professor
mesh term: Cognitive Dysfunction
sharing ipd: No