<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/NCT02979782</url>
  </required_header>
  <id_info>
    <org_study_id>16.115/anesth16.01</org_study_id>
    <nct_id>NCT02979782</nct_id>
  </id_info>
  <brief_title>Neurological Outcome After Minimal Invasive Coronary Artery Bypass Graft</brief_title>
  <acronym>NOMICS</acronym>
  <official_title>Neurological Outcome After Minimal Invasive Coronary Artery Bypass Graft: a Single-centre Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jessa Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary objectives:&#xD;
&#xD;
      Assessment of the incidence of postoperative cognitive dysfunction (POCD), cerebrovascular&#xD;
      accident (CVA), and delirium after minimal invasive coronary artery bypass grafting&#xD;
      (Endo-CABG).&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  Quality of life, three months after endo-CABG&#xD;
&#xD;
        -  Patient satisfaction with endo-CABG and the tests performed&#xD;
&#xD;
        -  The influence of various demographic and peri-operative variables on neurological&#xD;
           outcome after endo-CABG&#xD;
&#xD;
        -  Incidence of fear and depression, 3 months after endo-CABG&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Major improvements in surgical techniques, perfusion systems, and perioperative policies have&#xD;
      led to improved quality of life of the patient, lower hospitalisation costs, and lower&#xD;
      mortality rates in the field of cardiac surgery. However, despite these improvements and&#xD;
      improved postoperative care, the neurological outcome after cardiac surgery remains a&#xD;
      recurrent issue of interest. The most common neurological disorders after cardiac surgery are&#xD;
      postoperative cognitive dysfunction (POCD), cerebrovascular accident (CVA), and delirium.&#xD;
      After conventional cardiac surgery (invasive sternotomy procedure) the incidence of these&#xD;
      neurological disorders is well studied. POCD has an incidence of 25-50%, CVA has an incidence&#xD;
      of 1-5% and delirium has an incidence of 5-15%. These numbers prove that neurological outcome&#xD;
      still is a major problem after cardiac surgery.&#xD;
&#xD;
      Postoperative cognitive dysfunction (POCD) is the most common neurological disorder after&#xD;
      cardiac surgery. POCD is defined as a disturbance of the brain function, which is causally&#xD;
      related to surgery. Due to the multifactorial nature of POCD it is difficult to pinpoint one&#xD;
      major cause. testing of POCD is not standardised and is based on the '1995 statement of&#xD;
      concensus on assessment of neurobehavioural outcomes after cardiac surgery'. This consensus&#xD;
      statement describes the most reliable tests and study design to study POCD in clinical&#xD;
      studies.&#xD;
&#xD;
      A battery of tests is described in the consensus statement:&#xD;
&#xD;
        -  Rey auditory verbal learning test for verbal memory&#xD;
&#xD;
        -  Trailmaking A and B for attention&#xD;
&#xD;
        -  Grooved pegboard test for fine motor function&#xD;
&#xD;
      In this study, two additional tests will be performed to assess POCD:&#xD;
&#xD;
      the digit span test to test the short term verbal memory. the digit symbol-coding test to&#xD;
      test the processing speed and memory of the patient.&#xD;
&#xD;
      Additional recommendations of the consensus statement to conduct reliable POCD testing are:&#xD;
&#xD;
        -  Baseline testing&#xD;
&#xD;
        -  At least on assessment of POCD three months postoperatively&#xD;
&#xD;
        -  A control group and a comparative group&#xD;
&#xD;
        -  The same person tests both pre- and postoperatively&#xD;
&#xD;
        -  a clinical neurological investigation is necessary&#xD;
&#xD;
      Cerebrovascular accident (CVA or stroke) is caused by disturbances of the brain blood supply.&#xD;
      The main causes of these disturbances are clotted vessels, hypoperfusion, or ruptured vessels&#xD;
      in the brain. The risk of CVA is high in the first few days after cardiac surgery. CVA is&#xD;
      diagnosed based on neurological evaluation and signs on CT or MRI scan.&#xD;
&#xD;
      Delirium is characterised by attention disorders and fluctuating changes in the mental state&#xD;
      of the patient. Delirium is mainly related to surgery and can be diagnosed with the CAM-ICU&#xD;
      (confusion assessment method for the intensive care unit).&#xD;
&#xD;
      These neurological complications have a negative effect on the quality of life, healthcare&#xD;
      costs and mortality rate after cardiac surgery.&#xD;
&#xD;
      Recently, new developments in cardiac surgery hav led to the introduction of minimal invasive&#xD;
      cardiac procedures into practice. These minimal invasive cardiac procedures are proven to be&#xD;
      beneficial for the patient. Neurological outcome after minimal invasive cardiac surgery&#xD;
      however, is not well studied.&#xD;
&#xD;
      Therefore, the main goal of this study is to examine the neurological outcome after&#xD;
      endoscopic coronary artery bypass grafting (Endo-CABG). Endo-CABG is a minimal invasive&#xD;
      cardiac procedure based on the conventional coronary artery bypass grafting (CABG) procedure.&#xD;
&#xD;
      Study design and study tests:&#xD;
&#xD;
      This study will be a single-centre prospective cohort study. The goal of the study is to&#xD;
      assess the neurological outcome after endoscopic coronary artery bypass grafting (Endo-CABG).&#xD;
      Three study groups will be included (described in section study groups), which will be tested&#xD;
      for POCD, CVA and delirium.&#xD;
&#xD;
      Secondary outcomes in this research are quality of life of the patient (EQ-5D-5L), Fear and&#xD;
      depression outcomes (VVO; CES-D), and assessment of demographic and peri-operative predictors&#xD;
      of poor neurological outcome after endo-CABG.&#xD;
&#xD;
      Study tests:&#xD;
&#xD;
      Baseline tests will be performed in both intervention groups (Endo-CABG and PCI) and the&#xD;
      healthy control group.&#xD;
&#xD;
      In the intervention groups the baseline preoperative tests will include:&#xD;
&#xD;
        -  Baseline neurocognitive status: mini mental test&#xD;
&#xD;
        -  Baseline EQ-5D: Quality of life&#xD;
&#xD;
        -  Baseline fear and depression state (VVO; CES-D)&#xD;
&#xD;
        -  Preoperative clinical neurological investigation&#xD;
&#xD;
        -  Baseline POCD status (Rey auditory verbal learning test,Trailmaking A &amp; B, Grooved&#xD;
           pegboard test, Digit span test, Digit symbol-coding test)&#xD;
&#xD;
      For the healthy volunteers the same baseline tests will be performed, with exception of the&#xD;
      neurological clinical evaluation.&#xD;
&#xD;
      Postoperative tests in the intervention groups will include:&#xD;
&#xD;
        -  Postoperative neurologic clinical evaluation (CT scan if CVA suspected), CAM-ICU): these&#xD;
           tests will be performed at the ICU or ward&#xD;
&#xD;
        -  3 months after surgery: EQ-5d (quality of life), Fear and depression, POCD follow-up&#xD;
           (Rey auditory verbal learning test, Trailmaking A &amp; B, Grooved pegboard test, Digit span&#xD;
           test, Digit symbol-coding test)&#xD;
&#xD;
      For the healthy volunteers, the following tests will be performed 3 months after baseline&#xD;
      testing:&#xD;
&#xD;
        -  EQ-5d: quality of life&#xD;
&#xD;
        -  Stroke follow-up&#xD;
&#xD;
        -  Fear and depression&#xD;
&#xD;
        -  POCD status (Rey auditory verbal learning test,Trailmaking A &amp; B, Grooved pegboard test,&#xD;
           Digit span test, Digit symbol-coding test)&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      In this study POCD is defined as a decline in score between baseline and follow-up&#xD;
      neurophysiological test, which should be higher than the natural variation. In this setting&#xD;
      the natural learning effect will also be taken into account. To perform statistical analysis&#xD;
      for POCD testing, Z-scores (or reliable change index (RCI)) will be used. The Z-score is a&#xD;
      unit which indicates how the difference between the baseline score and the follow-up test&#xD;
      behaves compared to the mean scores of the control group.&#xD;
&#xD;
      Thus, the individual RCI scores will be calculated as follows:&#xD;
&#xD;
        -  For each patient, the baseline score from each test will be subtracted from the&#xD;
           follow-up score, giving Δx. The same will be done in the control group, giving Δxc. The&#xD;
           mean change on that test in the control group will then be subtracted from Δx to&#xD;
           eliminate practice effects.&#xD;
&#xD;
        -  This result will then be divided by the standard deviation of Δxc to eliminate the&#xD;
           effect of natural variation in test performance. This is called a Z-score.&#xD;
&#xD;
      The RCI is the sum of the Z-scores of all tests.&#xD;
&#xD;
      We defined POCD in an individual patient as an RCI equal to or less than -1.645 (significance&#xD;
      level 5%), or Z-score equal to or less than -1.645 in at least two different tests.&#xD;
&#xD;
      The group RCI scores will be compared using ANOVA or Kruskall-Wallis.&#xD;
&#xD;
      The quality of life will be tested using a mann-whitney U test at significance level 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Prevalence of postoperative cognitive dysfunction</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>percentage of total study population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of delirium</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>percentage of total study population</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of cerebrovascular accident</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>percentage of total study population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life of the patient</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>assessment with the EQ-5D questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of predictors of poor neurological outcome after minimal invasive coronary artery bypass grafting</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>assessment of which demographic and peri-operative variables are associated with poor neurological outcome after minimal invasive coronary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of depression after minimal invasive coronary artery bypass grafting</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>assessment with the CES-D questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of fear after minimal invasive coronary artery bypass grafting</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>assessment with the Surgical Fear Questionnaire</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">180</enrollment>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <condition>Cerebrovascular Accident</condition>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Endo-CABG, surgical group</arm_group_label>
    <description>the minimal invasive cardiac surgery group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCI, comparative surgical group</arm_group_label>
    <description>a comparative minimal invasive procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteer, control group</arm_group_label>
    <description>to exclude any learning effect or natural variation in neurological testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endo-CABG</intervention_name>
    <description>minimal invasive cardiac intervention</description>
    <arm_group_label>Endo-CABG, surgical group</arm_group_label>
    <other_name>minimal invasive Coronary Artery Bypass Grafting</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PCI</intervention_name>
    <description>stenting procedure</description>
    <arm_group_label>PCI, comparative surgical group</arm_group_label>
    <other_name>percutaneous coronary intervention</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population will be divided into three groups. The first group will be the Endo-CABG&#xD;
        group which consist of the patients who undergo minimal invasive coronary artery bypass&#xD;
        grafting.&#xD;
&#xD;
        The second group consists of patients who will get an elective PCI intervention. this is a&#xD;
        comparative group which is included to check whether the assessed prevalences in the&#xD;
        Endo-CABG group are not related to underlying cardiac anomalies or to other cardiac&#xD;
        intervention procedures.&#xD;
&#xD;
        The third group consists of healthy volunteers. This control group will be included to&#xD;
        eliminate natural variation in neurophysiological testing and to exclude the learning&#xD;
        effect which can occur when repeated neurophysiological testing is performed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age of 18&#xD;
&#xD;
          -  Elective Endo-CABG procedure (group 1)&#xD;
&#xD;
          -  Elective PCI procedure (group 2)&#xD;
&#xD;
          -  Elective healthy volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history of:&#xD;
&#xD;
          -  Postoperative cognitive dysfunction, delirium or cerebrovascular accident&#xD;
&#xD;
          -  symptomatic carotid artery disease&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Renal dysfunction: glomular filtration rate (GFR) &lt; 30 ml/min&#xD;
&#xD;
          -  Hepatic dysfunction: serum glutamic-oxaloacetic transaminase (SGOT)/ aspartate&#xD;
             aminotransferase (AST), or serum glutamic-pyruvic transaminase (SGPT)/ alanine&#xD;
             aminotransferase (ALT), more than three timer higher than normal limits&#xD;
&#xD;
          -  History of medication and alcohol abuse&#xD;
&#xD;
          -  Language barrier or incapability to communicate&#xD;
&#xD;
          -  Physical condition making participation impossible&#xD;
&#xD;
          -  Participation in other clinical trials of a drug or medical instrument&#xD;
&#xD;
          -  Surgical revision or intra-operative major cardial event (Endo-CABG group)&#xD;
&#xD;
          -  Conversion to cardiac surgery or intra-operative major event (PCI group)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Björn Stessel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>bjornstessel@hotmail.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Hospital</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessaziekenhuis Hasselt</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Likosky DS, Nugent WC, Ross CS; Northern New England Cardiovascular Disease Study Group. Improving outcomes of cardiac surgery through cooperative efforts: the northern new England experience. Semin Cardiothorac Vasc Anesth. 2005 Jun;9(2):119-21. doi: 10.1177/108925320500900203.</citation>
    <PMID>15920635</PMID>
  </reference>
  <reference>
    <citation>GILMAN S. CEREBRAL DISORDERS AFTER OPEN-HEART OPERATIONS. N Engl J Med. 1965 Mar 11;272:489-98. doi: 10.1056/NEJM196503112721001. No abstract available.</citation>
    <PMID>14250198</PMID>
  </reference>
  <reference>
    <citation>Furlan AJ, Sila CA, Chimowitz MI, Jones SC. Neurologic complications related to cardiac surgery. Neurol Clin. 1992 Feb;10(1):145-66.</citation>
    <PMID>1557000</PMID>
  </reference>
  <reference>
    <citation>Jensen BO, Hughes P, Rasmussen LS, Pedersen PU, Steinbruchel DA. Health-related quality of life following off-pump versus on-pump coronary artery bypass grafting in elderly moderate to high-risk patients: a randomized trial. Eur J Cardiothorac Surg. 2006 Aug;30(2):294-9. doi: 10.1016/j.ejcts.2006.04.015. Epub 2006 Jul 7.</citation>
    <PMID>16829089</PMID>
  </reference>
  <reference>
    <citation>Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. doi: 10.1161/hs1201.099803.</citation>
    <PMID>11739990</PMID>
  </reference>
  <reference>
    <citation>Newman MF. Open heart surgery and cognitive decline. Cleve Clin J Med. 2007 Feb;74 Suppl 1:S52-5. doi: 10.3949/ccjm.74.suppl_1.s52. No abstract available.</citation>
    <PMID>17455545</PMID>
  </reference>
  <reference>
    <citation>Ottens TH, Dieleman JM, Sauer AM, Peelen LM, Nierich AP, de Groot WJ, Nathoe HM, Buijsrogge MP, Kalkman CJ, van Dijk D; DExamethasone for Cardiac Surgery (DECS) Study Group. Effects of dexamethasone on cognitive decline after cardiac surgery: a randomized clinical trial. Anesthesiology. 2014 Sep;121(3):492-500. doi: 10.1097/ALN.0000000000000336.</citation>
    <PMID>25225745</PMID>
  </reference>
  <reference>
    <citation>Modi P, Chitwood WR Jr. Retrograde femoral arterial perfusion and stroke risk during minimally invasive mitral valve surgery: is there cause for concern? Ann Cardiothorac Surg. 2013 Nov;2(6):E1. doi: 10.3978/j.issn.2225-319X.2013.11.13.</citation>
    <PMID>24350000</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jessa Hospital</investigator_affiliation>
    <investigator_full_name>Stessel Björn</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>cardiac surgery</keyword>
  <keyword>neurological outcome</keyword>
  <keyword>minimal invasive coronary artery bypass graft (Endo-CABG)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02979782
org study id: 16.115/anesth16.01
nct id: NCT02979782
lead sponsor: 
collaborator: 
has dmc: No
Primary objectives:

      Assessment of the incidence of postoperative cognitive dysfunction (POCD), cerebrovascular
      accident (CVA), and delirium after minimal invasive coronary artery bypass grafting
      (Endo-CABG).

      Secondary objectives:

        -  Quality of life, three months after endo-CABG

        -  Patient satisfaction with endo-CABG and the tests performed

        -  The influence of various demographic and peri-operative variables on neurological
           outcome after endo-CABG

        -  Incidence of fear and depression, 3 months after endo-CABG
Introduction:

      Major improvements in surgical techniques, perfusion systems, and perioperative policies have
      led to improved quality of life of the patient, lower hospitalisation costs, and lower
      mortality rates in the field of cardiac surgery. However, despite these improvements and
      improved postoperative care, the neurological outcome after cardiac surgery remains a
      recurrent issue of interest. The most common neurological disorders after cardiac surgery are
      postoperative cognitive dysfunction (POCD), cerebrovascular accident (CVA), and delirium.
      After conventional cardiac surgery (invasive sternotomy procedure) the incidence of these
      neurological disorders is well studied. POCD has an incidence of 25-50%, CVA has an incidence
      of 1-5% and delirium has an incidence of 5-15%. These numbers prove that neurological outcome
      still is a major problem after cardiac surgery.

      Postoperative cognitive dysfunction (POCD) is the most common neurological disorder after
      cardiac surgery. POCD is defined as a disturbance of the brain function, which is causally
      related to surgery. Due to the multifactorial nature of POCD it is difficult to pinpoint one
      major cause. testing of POCD is not standardised and is based on the '1995 statement of
      concensus on assessment of neurobehavioural outcomes after cardiac surgery'. This consensus
      statement describes the most reliable tests and study design to study POCD in clinical
      studies.

      A battery of tests is described in the consensus statement:

        -  Rey auditory verbal learning test for verbal memory

        -  Trailmaking A and B for attention

        -  Grooved pegboard test for fine motor function

      In this study, two additional tests will be performed to assess POCD:

      the digit span test to test the short term verbal memory. the digit symbol-coding test to
      test the processing speed and memory of the patient.

      Additional recommendations of the consensus statement to conduct reliable POCD testing are:

        -  Baseline testing

        -  At least on assessment of POCD three months postoperatively

        -  A control group and a comparative group

        -  The same person tests both pre- and postoperatively

        -  a clinical neurological investigation is necessary

      Cerebrovascular accident (CVA or stroke) is caused by disturbances of the brain blood supply.
      The main causes of these disturbances are clotted vessels, hypoperfusion, or ruptured vessels
      in the brain. The risk of CVA is high in the first few days after cardiac surgery. CVA is
      diagnosed based on neurological evaluation and signs on CT or MRI scan.

      Delirium is characterised by attention disorders and fluctuating changes in the mental state
      of the patient. Delirium is mainly related to surgery and can be diagnosed with the CAM-ICU
      (confusion assessment method for the intensive care unit).

      These neurological complications have a negative effect on the quality of life, healthcare
      costs and mortality rate after cardiac surgery.

      Recently, new developments in cardiac surgery hav led to the introduction of minimal invasive
      cardiac procedures into practice. These minimal invasive cardiac procedures are proven to be
      beneficial for the patient. Neurological outcome after minimal invasive cardiac surgery
      however, is not well studied.

      Therefore, the main goal of this study is to examine the neurological outcome after
      endoscopic coronary artery bypass grafting (Endo-CABG). Endo-CABG is a minimal invasive
      cardiac procedure based on the conventional coronary artery bypass grafting (CABG) procedure.

      Study design and study tests:

      This study will be a single-centre prospective cohort study. The goal of the study is to
      assess the neurological outcome after endoscopic coronary artery bypass grafting (Endo-CABG).
      Three study groups will be included (described in section study groups), which will be tested
      for POCD, CVA and delirium.

      Secondary outcomes in this research are quality of life of the patient (EQ-5D-5L), Fear and
      depression outcomes (VVO; CES-D), and assessment of demographic and peri-operative predictors
      of poor neurological outcome after endo-CABG.

      Study tests:

      Baseline tests will be performed in both intervention groups (Endo-CABG and PCI) and the
      healthy control group.

      In the intervention groups the baseline preoperative tests will include:

        -  Baseline neurocognitive status: mini mental test

        -  Baseline EQ-5D: Quality of life

        -  Baseline fear and depression state (VVO; CES-D)

        -  Preoperative clinical neurological investigation

        -  Baseline POCD status (Rey auditory verbal learning test,Trailmaking A & B, Grooved
           pegboard test, Digit span test, Digit symbol-coding test)

      For the healthy volunteers the same baseline tests will be performed, with exception of the
      neurological clinical evaluation.

      Postoperative tests in the intervention groups will include:

        -  Postoperative neurologic clinical evaluation (CT scan if CVA suspected), CAM-ICU): these
           tests will be performed at the ICU or ward

        -  3 months after surgery: EQ-5d (quality of life), Fear and depression, POCD follow-up
           (Rey auditory verbal learning test, Trailmaking A & B, Grooved pegboard test, Digit span
           test, Digit symbol-coding test)

      For the healthy volunteers, the following tests will be performed 3 months after baseline
      testing:

        -  EQ-5d: quality of life

        -  Stroke follow-up

        -  Fear and depression

        -  POCD status (Rey auditory verbal learning test,Trailmaking A & B, Grooved pegboard test,
           Digit span test, Digit symbol-coding test)

      Statistical analysis:

      In this study POCD is defined as a decline in score between baseline and follow-up
      neurophysiological test, which should be higher than the natural variation. In this setting
      the natural learning effect will also be taken into account. To perform statistical analysis
      for POCD testing, Z-scores (or reliable change index (RCI)) will be used. The Z-score is a
      unit which indicates how the difference between the baseline score and the follow-up test
      behaves compared to the mean scores of the control group.

      Thus, the individual RCI scores will be calculated as follows:

        -  For each patient, the baseline score from each test will be subtracted from the
           follow-up score, giving Δx. The same will be done in the control group, giving Δxc. The
           mean change on that test in the control group will then be subtracted from Δx to
           eliminate practice effects.

        -  This result will then be divided by the standard deviation of Δxc to eliminate the
           effect of natural variation in test performance. This is called a Z-score.

      The RCI is the sum of the Z-scores of all tests.

      We defined POCD in an individual patient as an RCI equal to or less than -1.645 (significance
      level 5%), or Z-score equal to or less than -1.645 in at least two different tests.

      The group RCI scores will be compared using ANOVA or Kruskall-Wallis.

      The quality of life will be tested using a mann-whitney U test at significance level 5%.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of postoperative cognitive dysfunction
time frame: 3 months after intervention
description: percentage of total study population
measure: Prevalence of delirium
time frame: 3 months after intervention
description: percentage of total study population
measure: Prevalence of cerebrovascular accident
time frame: 3 months after intervention
description: percentage of total study population
measure: Quality of life of the patient
time frame: 3 months after intervention
description: assessment with the EQ-5D questionnaire
measure: assessment of predictors of poor neurological outcome after minimal invasive coronary artery bypass grafting
time frame: 3 months after intervention
description: assessment of which demographic and peri-operative variables are associated with poor neurological outcome after minimal invasive coronary
measure: Incidence of depression after minimal invasive coronary artery bypass grafting
time frame: 3 months after intervention
description: assessment with the CES-D questionnaire
measure: Incidence of fear after minimal invasive coronary artery bypass grafting
time frame: 3 months after intervention
description: assessment with the Surgical Fear Questionnaire
arm group label: Endo-CABG, surgical group
description: the minimal invasive cardiac surgery group
arm group label: PCI, comparative surgical group
description: a comparative minimal invasive procedure
arm group label: Healthy volunteer, control group
description: to exclude any learning effect or natural variation in neurological testing
intervention type: Procedure
intervention name: Endo-CABG
description: minimal invasive cardiac intervention
arm group label: Endo-CABG, surgical group
other name: minimal invasive Coronary Artery Bypass Grafting
intervention type: Procedure
intervention name: PCI
description: stenting procedure
arm group label: PCI, comparative surgical group
other name: percutaneous coronary intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Björn Stessel, MD, PhD
role: Principal Investigator
affiliation: bjornstessel@hotmail.com
facility: 
facility: 
country: Belgium
citation: Likosky DS, Nugent WC, Ross CS; Northern New England Cardiovascular Disease Study Group. Improving outcomes of cardiac surgery through cooperative efforts: the northern new England experience. Semin Cardiothorac Vasc Anesth. 2005 Jun;9(2):119-21. doi: 10.1177/108925320500900203.
PMID: 15920635
citation: GILMAN S. CEREBRAL DISORDERS AFTER OPEN-HEART OPERATIONS. N Engl J Med. 1965 Mar 11;272:489-98. doi: 10.1056/NEJM196503112721001. No abstract available.
PMID: 14250198
citation: Furlan AJ, Sila CA, Chimowitz MI, Jones SC. Neurologic complications related to cardiac surgery. Neurol Clin. 1992 Feb;10(1):145-66.
PMID: 1557000
citation: Jensen BO, Hughes P, Rasmussen LS, Pedersen PU, Steinbruchel DA. Health-related quality of life following off-pump versus on-pump coronary artery bypass grafting in elderly moderate to high-risk patients: a randomized trial. Eur J Cardiothorac Surg. 2006 Aug;30(2):294-9. doi: 10.1016/j.ejcts.2006.04.015. Epub 2006 Jul 7.
PMID: 16829089
citation: Newman MF, Grocott HP, Mathew JP, White WD, Landolfo K, Reves JG, Laskowitz DT, Mark DB, Blumenthal JA; Neurologic Outcome Research Group and the Cardiothoracic Anesthesia Research Endeavors (CARE) Investigators of the Duke Heart Center. Report of the substudy assessing the impact of neurocognitive function on quality of life 5 years after cardiac surgery. Stroke. 2001 Dec 1;32(12):2874-81. doi: 10.1161/hs1201.099803.
PMID: 11739990
citation: Newman MF. Open heart surgery and cognitive decline. Cleve Clin J Med. 2007 Feb;74 Suppl 1:S52-5. doi: 10.3949/ccjm.74.suppl_1.s52. No abstract available.
PMID: 17455545
citation: Ottens TH, Dieleman JM, Sauer AM, Peelen LM, Nierich AP, de Groot WJ, Nathoe HM, Buijsrogge MP, Kalkman CJ, van Dijk D; DExamethasone for Cardiac Surgery (DECS) Study Group. Effects of dexamethasone on cognitive decline after cardiac surgery: a randomized clinical trial. Anesthesiology. 2014 Sep;121(3):492-500. doi: 10.1097/ALN.0000000000000336.
PMID: 25225745
citation: Modi P, Chitwood WR Jr. Retrograde femoral arterial perfusion and stroke risk during minimally invasive mitral valve surgery: is there cause for concern? Ann Cardiothorac Surg. 2013 Nov;2(6):E1. doi: 10.3978/j.issn.2225-319X.2013.11.13.
PMID: 24350000
responsible party type: Principal Investigator
investigator affiliation: Jessa Hospital
investigator full name: Stessel Björn
investigator title: MD
mesh term: Stroke
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
sharing ipd: Undecided