<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/NCT03018561</url>
  </required_header>
  <id_info>
    <org_study_id>COGNEX-1</org_study_id>
    <nct_id>NCT03018561</nct_id>
  </id_info>
  <brief_title>Brain, Cardiac Hemodynamics and Cognition During Exercise in Subjects With Various Cardiovascular Profiles</brief_title>
  <acronym>COGNEX</acronym>
  <official_title>Cerebral Oxygenation, Cardiac Output, COGnitive Function, and EXercise in Patients With Metabolic Syndrome, Coronary Heart Disease and Chronic Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montreal Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montreal Heart Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with cardiovascular risk (CV) factors (obesity, diabetes, etc...) or established heart&#xD;
      disease (such as coronary heart disease or chronic heart failure) often have cognitive&#xD;
      dysfunction as compared to people without CV risk factors or heart disease. Among the&#xD;
      mechanisms, a reduced cardiac output and cerebral blood flow in those people have been&#xD;
      suggested. The aim of this study was to compare resting cognitive function, maximal&#xD;
      cardiopulmonary function, cardiac output and cerebral hemodynamics during exercise in&#xD;
      patients with metabolic syndrome, coronary heart disease, or heart failure vs. healthy&#xD;
      subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All subjects will underwent a baseline evaluation including a medical history, physical&#xD;
      examination with measurement of height and weight, body composition and fasting blood sample.&#xD;
      All subjects will performed a cognitive testing at rest and a maximal cardiopulmonary&#xD;
      exercise test (CEPT) with gas exchange analysis. During CEPT, cerebral oxygenation (measured&#xD;
      by near-infra red spectroscopy) and cardiac hemodynamics responses (impedance cardiography)&#xD;
      will be measured continuously.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">January 15, 2018</completion_date>
  <primary_completion_date type="Actual">January 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebral hemodynamics measured with near-infra red spectroscopy (NIRS)</measure>
    <time_frame>Measured within 2 weeks</time_frame>
    <description>Total haemoglobin (ΔtHb): index of brain perfusion (in µM) measured during maximal exercise test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resting cognitive function (assessed by the battery test)</measure>
    <time_frame>Measured within 2 weeks</time_frame>
    <description>Resting cognitive function : will be evaluated by a validated paper-and-pencil full neuropsychological battery test that include: - D-KEFS Color-Word Interference Stroop test : time (sec.)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>aged-gender matched healthy controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy subjects: with no MetS and no-documented coronary heart disease (CHD), both males and females, aged&gt;18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with metabolic syndrome</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with MetS and no-documented CHD, both males and females, aged &gt; 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Metabolic syndrome (MetS) will be defined according to recent updated criteria (Alberti et al. 2005):presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides &gt; 1.70 mmol/l, decreased HDL-cholesterol (&lt; 1.0 mmol/l in men and &lt; 1.3 mmol/l in women), systolic blood pressure &gt; 130 mmHg or diastolic blood pressure &gt; 85 mmHg, and FPG &gt; 5.6 mmol/l.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with coronary heart disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CHD patients, both males and females, aged &gt; 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with chronic heart failure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria:&#xD;
≥18 years&#xD;
Left ventricular ejection fraction (LVEF) &lt;40% (measured within 6 months of their enrolment by a multigated acquisition Scan, echo or radiological ventriculography)&#xD;
NYHA functional class I-III&#xD;
Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or ARA for at least 6 weeks prior to investigation (unless documented rationale for variation).&#xD;
Able to perform an symptom limited exercise test.&#xD;
Capacity and willingness to sign the informed consent form.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise and Cognitive testing</intervention_name>
    <description>Maximal cardiopulmonary test Rest cognitive testing</description>
    <arm_group_label>aged-gender matched healthy controls</arm_group_label>
    <arm_group_label>patients with chronic heart failure</arm_group_label>
    <arm_group_label>patients with coronary heart disease</arm_group_label>
    <arm_group_label>patients with metabolic syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Healthy subjects: with no MetS and no-documented CHD, both males and females, aged&gt;18&#xD;
             years will be included in the study, should they provide written informed consent and&#xD;
             have a sufficient initial physical and intellectual capacities allowing an independent&#xD;
             daily living.&#xD;
&#xD;
          -  Patients with MetS and no-documented CHD, both males and females, aged &gt; 18 years will&#xD;
             be included in the study, should they provide written informed consent and have a&#xD;
             sufficient initial physical and intellectual capacities allowing an independent daily&#xD;
             living. MetS will be defined according to recent updated criteria (Alberti et al.&#xD;
             2005):presence of at least three of five criteria, namely abdominal obesity (waist&#xD;
             circumference cut-off depending on the recently published ethnic-based variations,&#xD;
             triglycerides &gt; 1.70 mmol/l, decreased HDL-cholesterol (&lt; 1.0 mmol/l in men and &lt; 1.3&#xD;
             mmol/l in women), systolic blood pressure &gt; 130 mmHg or diastolic blood pressure &gt; 85&#xD;
             mmHg, and FPG &gt; 5.6 mmol/l.&#xD;
&#xD;
          -  CHD patients, both males and females, aged &gt; 18 years will be included in the study,&#xD;
             should they provide written informed consent and have a sufficient initial physical&#xD;
             and intellectual capacities allowing an independent daily living. Moreover, they must&#xD;
             have documented CHD (prior myocardial infarction, prior coronary angiography or&#xD;
             angioplasty, or documented myocardial ischemia on myocardial scintigraphy).&#xD;
&#xD;
          -  Patients with documented stable chronic heart failure will be recruited if they show&#xD;
             the following inclusion criteria:&#xD;
&#xD;
               -  ≥18 years&#xD;
&#xD;
               -  Left ventricular ejection fraction (LVEF) &lt;40% (measured within 6 months of their&#xD;
                  enrolment by MUGA Scan, echo or radiological ventriculography)&#xD;
&#xD;
               -  NYHA functional class I-III&#xD;
&#xD;
               -  Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or&#xD;
                  ARA for at least 6 weeks prior to investigation (unless documented rationale for&#xD;
                  variation).&#xD;
&#xD;
               -  Able to perform an symptom limited exercise test.&#xD;
&#xD;
               -  Capacity and willingness to sign the informed consent form.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        For healthy subjects:&#xD;
&#xD;
          -  lack of expressed written consent&#xD;
&#xD;
          -  metabolic syndrome&#xD;
&#xD;
          -  coronary heart disease&#xD;
&#xD;
          -  chronic systolic heart failure&#xD;
&#xD;
          -  resting left ventricular ejection fraction &lt; 40 %&#xD;
&#xD;
          -  symptomatic aortic stenosis&#xD;
&#xD;
          -  chronic atrial fibrillation&#xD;
&#xD;
          -  malignant exertional arrhythmias&#xD;
&#xD;
          -  non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)&#xD;
&#xD;
          -  severe exercise intolerance.&#xD;
&#xD;
        For patients with MetS:&#xD;
&#xD;
          -  lack of expressed written consent&#xD;
&#xD;
          -  coronary heart disease&#xD;
&#xD;
          -  chronic systolic heart failure&#xD;
&#xD;
          -  resting left ventricular ejection fraction &lt; 40 %&#xD;
&#xD;
          -  symptomatic aortic stenosis&#xD;
&#xD;
          -  chronic atrial fibrillation&#xD;
&#xD;
          -  malignant exertional arrhythmias&#xD;
&#xD;
          -  non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)&#xD;
&#xD;
          -  severe exercise intolerance.&#xD;
&#xD;
        For patients with CHD&#xD;
&#xD;
          -  lack of expressed written consent&#xD;
&#xD;
          -  recent acute coronary event (&lt; 3 months)&#xD;
&#xD;
          -  chronic systolic heart failure&#xD;
&#xD;
          -  resting left ventricular ejection fraction &lt; 40 %&#xD;
&#xD;
          -  symptomatic aortic stenosis&#xD;
&#xD;
          -  severe non-revascularizable coronary disease including left main coronary stenosis&#xD;
&#xD;
          -  patient awaiting coronary artery bypass surgery&#xD;
&#xD;
          -  chronic atrial fibrillation&#xD;
&#xD;
          -  presence of permanent ventricular pacemaker&#xD;
&#xD;
          -  malignant exertional arrhythmias&#xD;
&#xD;
          -  non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)&#xD;
&#xD;
          -  severe exercise intolerance.&#xD;
&#xD;
        For CHF patients:&#xD;
&#xD;
          -  Any relative or absolute contraindications to exercise training among patients with&#xD;
             stable chronic heart failure according to current recommendations (Working Group on&#xD;
             Cardiac Rehabilitation 2001)&#xD;
&#xD;
          -  Fixed-rate pacemaker or ICD devices with heart rate limits set lower than the exercise&#xD;
             training target heart rate.&#xD;
&#xD;
          -  Major cardiovascular event of procedure within the 3 months preceding enrolment in the&#xD;
             study.&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Heart failure secondary to significant uncorrected primary valvular disease (except&#xD;
             for mitral regurgitation secondary to LV dysfunction)&#xD;
&#xD;
          -  Heart failure secondary to congenital heart disease or obstructive cardiomyopathy.&#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>Anil Nigam, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montreal Heart Institute</affiliation>
  </overall_official>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no IPD plan</ipd_description>
  </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/NCT03018561
org study id: COGNEX-1
nct id: NCT03018561
lead sponsor: 
has dmc: No
People with cardiovascular risk (CV) factors (obesity, diabetes, etc...) or established heart
      disease (such as coronary heart disease or chronic heart failure) often have cognitive
      dysfunction as compared to people without CV risk factors or heart disease. Among the
      mechanisms, a reduced cardiac output and cerebral blood flow in those people have been
      suggested. The aim of this study was to compare resting cognitive function, maximal
      cardiopulmonary function, cardiac output and cerebral hemodynamics during exercise in
      patients with metabolic syndrome, coronary heart disease, or heart failure vs. healthy
      subjects.
All subjects will underwent a baseline evaluation including a medical history, physical
      examination with measurement of height and weight, body composition and fasting blood sample.
      All subjects will performed a cognitive testing at rest and a maximal cardiopulmonary
      exercise test (CEPT) with gas exchange analysis. During CEPT, cerebral oxygenation (measured
      by near-infra red spectroscopy) and cardiac hemodynamics responses (impedance cardiography)
      will be measured continuously.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Cerebral hemodynamics measured with near-infra red spectroscopy (NIRS)
time frame: Measured within 2 weeks
description: Total haemoglobin (ΔtHb): index of brain perfusion (in µM) measured during maximal exercise test.
measure: Resting cognitive function (assessed by the battery test)
time frame: Measured within 2 weeks
description: Resting cognitive function : will be evaluated by a validated paper-and-pencil full neuropsychological battery test that include: - D-KEFS Color-Word Interference Stroop test : time (sec.)
arm group label: aged-gender matched healthy controls
arm group type: Active Comparator
description: Healthy subjects: with no MetS and no-documented coronary heart disease (CHD), both males and females, aged>18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living.
arm group label: patients with metabolic syndrome
arm group type: Experimental
description: Patients with MetS and no-documented CHD, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Metabolic syndrome (MetS) will be defined according to recent updated criteria (Alberti et al. 2005):presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l.
arm group label: patients with coronary heart disease
arm group type: Experimental
description: CHD patients, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy).
arm group label: patients with chronic heart failure
arm group type: Experimental
description: Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria:
≥18 years
Left ventricular ejection fraction (LVEF) <40% (measured within 6 months of their enrolment by a multigated acquisition Scan, echo or radiological ventriculography)
NYHA functional class I-III
Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or ARA for at least 6 weeks prior to investigation (unless documented rationale for variation).
Able to perform an symptom limited exercise test.
Capacity and willingness to sign the informed consent form.
intervention type: Other
intervention name: Exercise and Cognitive testing
description: Maximal cardiopulmonary test Rest cognitive testing
arm group label: aged-gender matched healthy controls
arm group label: patients with chronic heart failure
arm group label: patients with coronary heart disease
arm group label: patients with metabolic syndrome
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anil Nigam, M.D
role: Principal Investigator
affiliation: Montreal Heart Institute
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Coronary Artery Disease
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No
ipd description: no IPD plan