<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/NCT03248921</url>
  </required_header>
  <id_info>
    <org_study_id>RS#: 2014-2006</org_study_id>
    <nct_id>NCT03248921</nct_id>
  </id_info>
  <brief_title>The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery</brief_title>
  <acronym>OPOS</acronym>
  <official_title>The Impact of Obesity on Postoperative Outcomes Following Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiovascular Research New Brunswick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Horizon Health Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maritime Heart Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiovascular Research New Brunswick</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify measures of obesity, functional capacity, and&#xD;
      specific biomarkers that may be predictive of obesity and post-operative outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Increasing levels of obesity worldwide have led to a rise in the prevalence of&#xD;
      obesity-related complications including cardiovascular disease, diabetes, cancers etc. Health&#xD;
      care providers believe that obesity has a negative effect on patients undergoing cardiac&#xD;
      surgery, with overweight and obese patients being more likely to experience adverse&#xD;
      post-operative outcomes. The body mass index (BMI) is the single most used measure for&#xD;
      determining obesity classification in clinical practice, without accounting for a patient's&#xD;
      level of cardiopulmonary fitness or muscle mass.&#xD;
&#xD;
      Study Design: Patients between the ages of 18 and 75 years undergoing elective cardiac&#xD;
      surgery will be consented to participate in this prospective observational trial. Patients&#xD;
      are invited to participate in measures of obesity, functional capacity and exercise capacity&#xD;
      assessments, quality of life questionnaires, and blood and tissue sampling for biomarker&#xD;
      analysis.&#xD;
&#xD;
      Endpoints: Measures other than BMI that could be predictive of short-term and long-term&#xD;
      post-operative outcomes. Outcomes of interest include: prolonged length of ventilation,&#xD;
      hospital length of stay and all-cause mortality.&#xD;
&#xD;
      Summary: The results of this trial will potentially identify an improved definition of&#xD;
      fitness capacity for obese cardiac surgical patients and biomarkers alone or in combination&#xD;
      that could identify the potential for adverse outcomes in patients undergoing cardiac&#xD;
      surgery. This study will help clinicians better segregate and treat patients pre-operatively&#xD;
      based on fitness levels and associated biomarkers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Anticipated">November 2030</completion_date>
  <primary_completion_date type="Anticipated">November 2025</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>Prolonged Hospitalization</measure>
    <time_frame>post-operative day (POD) 30</time_frame>
    <description>A length of stay of more than 5 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prolonged ventilation &gt; 24 hours</measure>
    <time_frame>post-operative day (POD) 30</time_frame>
    <description>mechanical ventilation for more than 24 hours of invasive (via endotracheal tube or tracheostomy) and/or noninvasive (facial/nasal interface) methods of delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>all cause mortality</measure>
    <time_frame>post-operative day (POD) 30 and 1 year post-op</time_frame>
    <description>Patient death, either in hospital or long-term</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>non fatal myocardial infarction</measure>
    <time_frame>post-operative day (POD) 30 and 1 year post-op</time_frame>
    <description>Transmural, Subendocardial infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>post-operative day (POD) 30</time_frame>
    <description>Transient, permanent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory complications</measure>
    <time_frame>post-operative day (POD) 30</time_frame>
    <description>Pleural effusion, pneumonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolonged ICU length of stay</measure>
    <time_frame>post-operative day (POD) 30</time_frame>
    <description>length of stay of more than 48 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operation for any cause</measure>
    <time_frame>post-operative day (POD) 30 and 1 year post-op</time_frame>
    <description>re-operation due to complications, bleeding and/or other reasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation</measure>
    <time_frame>post-operative day (POD) 30 and 1 year post-op</time_frame>
    <description>post-op occurrence requiring treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative length of stay and disposition on discharge</measure>
    <time_frame>post-operative day (POD) 30 and 1 year post-op</time_frame>
    <description>home, home with care, transfer to other facility, or expired</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound infection</measure>
    <time_frame>post-operative day (POD) 30</time_frame>
    <description>infection of sternum or other incisional access sites</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">610</enrollment>
  <condition>Obesity</condition>
  <condition>Cardiac Disease</condition>
  <condition>Cardiovascular Syndromes, Metabolic</condition>
  <arm_group>
    <arm_group_label>High-Fit obese</arm_group_label>
    <description>Cardiac surgery patients will be segregated into the high-fit group based on 6 minute walk test distance and other measures of functional capacity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-Fit obese</arm_group_label>
    <description>Cardiac surgery patients will be segregated into the low-fit group based on 6 minute walk test distance and other measures of functional capacity</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiac surgery</intervention_name>
    <description>cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery</description>
    <arm_group_label>High-Fit obese</arm_group_label>
    <arm_group_label>Low-Fit obese</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The following biological samples have been approved for collection: 4 types of adipose tissue&#xD;
      (subcutaneous adipose tissue; epicardial adipose tissue; pericardial adipose tissue;&#xD;
      peri-aortic adipose tissue); atrial appendage tissue sample; and 8-10mL blood sample (plasma&#xD;
      and serum sample).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients scheduled to undergo elective, first-time cardiac surgery will be considered&#xD;
        for eligibility to participate in the study. As well, a patient whose BMI is less than 18.5&#xD;
        kg/m2 and classified as underweight by the World Health Organization will be excluded. Only&#xD;
        those patients who are classified as being normal weight range or overweight and/or obese&#xD;
        may be considered for eligibility to participate as defined by the study objectives&#xD;
        regarding post-operative cardiac surgery outcomes in obese patients. Patients in the normal&#xD;
        weight range classification will be included as a baseline control participant cohort.&#xD;
        Finally, patients over the age of 75 will be excluded so as to eliminate the role that&#xD;
        advanced age may play in affecting functional capacity.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  · Provide informed consent&#xD;
&#xD;
               -  Male or female patients who are &gt; 18 years of age&#xD;
&#xD;
               -  Patients must be scheduled to undergo elective, first-time cardiac surgery during&#xD;
                  routine scheduling times&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are &gt; 75 years of age&#xD;
&#xD;
          -  BMI is less than 18.5 kg/m2 and classified as underweight according to the World&#xD;
             Health Organization&#xD;
&#xD;
          -  Any non-elective first time cardiac surgery patient (eg. in-house urgent patients;&#xD;
             emergent patients)&#xD;
&#xD;
          -  Any cardiac patients to undergo re-operation&#xD;
&#xD;
          -  Simultaneous participation in another study with an investigational study agent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ansar Hassan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New Brunswick Heart Centre, Department of Cardiac Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint John Regional Hospital</name>
      <address>
        <city>Saint John</city>
        <state>New Brunswick</state>
        <zip>E2L 4L2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://impart.team/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Aguiar C, MacLeod J, Yip A, Melville S, Legare JF, Pulinilkunnil T, Kienesberger P, Brunt K, Hassan A. Impact of Obesity on Postoperative Outcomes following cardiac Surgery (The OPOS study): rationale and design of an investigator-initiated prospective study. BMJ Open. 2019 Mar 3;9(3):e023418. doi: 10.1136/bmjopen-2018-023418.</citation>
    <PMID>30833313</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dalhousie University</investigator_affiliation>
    <investigator_full_name>Ansar Hassan, MD, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Metabolic Syndrome</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/NCT03248921
org study id: RS#: 2014-2006
nct id: NCT03248921
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to identify measures of obesity, functional capacity, and
      specific biomarkers that may be predictive of obesity and post-operative outcomes.
Background: Increasing levels of obesity worldwide have led to a rise in the prevalence of
      obesity-related complications including cardiovascular disease, diabetes, cancers etc. Health
      care providers believe that obesity has a negative effect on patients undergoing cardiac
      surgery, with overweight and obese patients being more likely to experience adverse
      post-operative outcomes. The body mass index (BMI) is the single most used measure for
      determining obesity classification in clinical practice, without accounting for a patient's
      level of cardiopulmonary fitness or muscle mass.

      Study Design: Patients between the ages of 18 and 75 years undergoing elective cardiac
      surgery will be consented to participate in this prospective observational trial. Patients
      are invited to participate in measures of obesity, functional capacity and exercise capacity
      assessments, quality of life questionnaires, and blood and tissue sampling for biomarker
      analysis.

      Endpoints: Measures other than BMI that could be predictive of short-term and long-term
      post-operative outcomes. Outcomes of interest include: prolonged length of ventilation,
      hospital length of stay and all-cause mortality.

      Summary: The results of this trial will potentially identify an improved definition of
      fitness capacity for obese cardiac surgical patients and biomarkers alone or in combination
      that could identify the potential for adverse outcomes in patients undergoing cardiac
      surgery. This study will help clinicians better segregate and treat patients pre-operatively
      based on fitness levels and associated biomarkers.
observational model: Cohort
time perspective: Prospective
measure: Prolonged Hospitalization
time frame: post-operative day (POD) 30
description: A length of stay of more than 5 days
measure: Prolonged ventilation > 24 hours
time frame: post-operative day (POD) 30
description: mechanical ventilation for more than 24 hours of invasive (via endotracheal tube or tracheostomy) and/or noninvasive (facial/nasal interface) methods of delivery
measure: all cause mortality
time frame: post-operative day (POD) 30 and 1 year post-op
description: Patient death, either in hospital or long-term
measure: non fatal myocardial infarction
time frame: post-operative day (POD) 30 and 1 year post-op
description: Transmural, Subendocardial infarction
measure: Stroke
time frame: post-operative day (POD) 30
description: Transient, permanent
measure: Respiratory complications
time frame: post-operative day (POD) 30
description: Pleural effusion, pneumonia
measure: Prolonged ICU length of stay
time frame: post-operative day (POD) 30
description: length of stay of more than 48 hours
measure: Re-operation for any cause
time frame: post-operative day (POD) 30 and 1 year post-op
description: re-operation due to complications, bleeding and/or other reasons
measure: Atrial fibrillation
time frame: post-operative day (POD) 30 and 1 year post-op
description: post-op occurrence requiring treatment
measure: Post-operative length of stay and disposition on discharge
time frame: post-operative day (POD) 30 and 1 year post-op
description: home, home with care, transfer to other facility, or expired
measure: Wound infection
time frame: post-operative day (POD) 30
description: infection of sternum or other incisional access sites
arm group label: High-Fit obese
description: Cardiac surgery patients will be segregated into the high-fit group based on 6 minute walk test distance and other measures of functional capacity
arm group label: Low-Fit obese
description: Cardiac surgery patients will be segregated into the low-fit group based on 6 minute walk test distance and other measures of functional capacity
intervention type: Procedure
intervention name: cardiac surgery
description: cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery
arm group label: High-Fit obese
arm group label: Low-Fit obese
The following biological samples have been approved for collection: 4 types of adipose tissue
      (subcutaneous adipose tissue; epicardial adipose tissue; pericardial adipose tissue;
      peri-aortic adipose tissue); atrial appendage tissue sample; and 8-10mL blood sample (plasma
      and serum sample).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ansar Hassan, MD, PhD
role: Principal Investigator
affiliation: New Brunswick Heart Centre, Department of Cardiac Surgery
facility: 
country: Canada
url: https://impart.team/
description: Related Info
citation: Aguiar C, MacLeod J, Yip A, Melville S, Legare JF, Pulinilkunnil T, Kienesberger P, Brunt K, Hassan A. Impact of Obesity on Postoperative Outcomes following cardiac Surgery (The OPOS study): rationale and design of an investigator-initiated prospective study. BMJ Open. 2019 Mar 3;9(3):e023418. doi: 10.1136/bmjopen-2018-023418.
PMID: 30833313
responsible party type: Principal Investigator
investigator affiliation: Dalhousie University
investigator full name: Ansar Hassan, MD, PhD
investigator title: Principal Investigator
mesh term: Heart Diseases
mesh term: Obesity
mesh term: Metabolic Syndrome
sharing ipd: Undecided