Metabolic SyndromeCOGNEXNCT03018561
Brain, Cardiac Hemodynamics and Cognition During Exercise in Subjects With Various Cardiovascular Profiles
A study testing Exercise and Cognitive testing in people with Metabolic Syndrome and Coronary Artery Disease, run by Montreal Heart Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Coronary Artery Disease, Heart Failure
- What is being tested?
- Exercise and Cognitive testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to 15 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects: with no 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.
- 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. 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.
- 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).
- 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 MUGA Scan, echo or radiological ventriculography)
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- 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.
Who cannot join
- For healthy subjects:
- lack of expressed written consent
- metabolic syndrome
- coronary heart disease
- chronic systolic heart failure
- resting left ventricular ejection fraction < 40 %
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- symptomatic aortic stenosis
- chronic atrial fibrillation
- malignant exertional arrhythmias
- non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)
- severe exercise intolerance.
- For patients with MetS:
- lack of expressed written consent
- coronary heart disease
- chronic systolic heart failure
- resting left ventricular ejection fraction < 40 %
- symptomatic aortic stenosis
- chronic atrial fibrillation
- malignant exertional arrhythmias
- non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)
- severe exercise intolerance.
- For patients with CHD
- lack of expressed written consent
- recent acute coronary event (< 3 months)
- chronic systolic heart failure
- resting left ventricular ejection fraction < 40 %
- symptomatic aortic stenosis
- severe non-revascularizable coronary disease including left main coronary stenosis
- patient awaiting coronary artery bypass surgery
- chronic atrial fibrillation
- presence of permanent ventricular pacemaker
- malignant exertional arrhythmias
- non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)
- severe exercise intolerance.
- For CHF patients:
- Any relative or absolute contraindications to exercise training among patients with stable chronic heart failure according to current recommendations (Working Group on Cardiac Rehabilitation 2001)
- Fixed-rate pacemaker or ICD devices with heart rate limits set lower than the exercise training target heart rate.
- Major cardiovascular event of procedure within the 3 months preceding enrolment in the study.
- Atrial fibrillation
- Heart failure secondary to significant uncorrected primary valvular disease (except for mitral regurgitation secondary to LV dysfunction)
- Heart failure secondary to congenital heart disease or obstructive cardiomyopathy.
About this study
Official title: Cerebral Oxygenation, Cardiac Output, COGnitive Function, and EXercise in Patients With Metabolic Syndrome, Coronary Heart Disease and Chronic Heart Failure
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.
Read the detailed description
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.
- Conditions
- Metabolic Syndrome, Coronary Artery Disease, Heart Failure
- Being tested
- Exercise and Cognitive testing
- Medical subject headings
- Metabolic Syndrome, Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Cognitive testingOther
Maximal cardiopulmonary test Rest cognitive testing
| Study group | Role | What they receive |
|---|---|---|
| aged-gender matched healthy controls | Active comparator | 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. Receives: Other: Exercise and Cognitive testing |
| patients with metabolic syndrome | Experimental | 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. Receives: Other: Exercise and Cognitive testing |
| patients with coronary heart disease | Experimental | 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). Receives: Other: Exercise and Cognitive testing |
| patients with chronic heart failure | Experimental | 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. Receives: Other: Exercise and Cognitive testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral hemodynamics measured with near-infra red spectroscopy (NIRS)
Total haemoglobin (ΔtHb): index of brain perfusion (in µM) measured during maximal exercise test.
Measured: Measured within 2 weeks
Secondary outcomes (1)
Resting cognitive function (assessed by the battery test)
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.)
Measured: Measured within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2011
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anil Nigam, M.D, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018561
- Sponsor's protocol ID
- COGNEX-1
- Acronym
- COGNEX
- Status last verified
- Nov 2024
- First submitted
- 6 Dec 2016
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no IPD plan
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygenation, Cardiac Output, COGnitive Function, and EXercise in Patients With Metabolic Syndrome, Coronary Heart Disease and Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03018561
- Acronym / sponsor ID
- COGNEX / COGNEX-1
- Conditions
- Metabolic Syndrome, Coronary Artery Disease, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| aged-gender matched healthy controls | Active comparator | Other: Exercise and Cognitive testingHealthy 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. |
| patients with metabolic syndrome | Experimental | Other: Exercise and Cognitive testingPatients 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. |
| patients with coronary heart disease | Experimental | Other: Exercise and Cognitive testingCHD 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). |
| patients with chronic heart failure | Experimental | Other: Exercise and Cognitive testingPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy subjects: with no 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.
- 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. 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.
- 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).
- Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria:
Key exclusion criteria (41 listed)
- lack of expressed written consent
- metabolic syndrome
- coronary heart disease
- chronic systolic heart failure
- resting left ventricular ejection fraction < 40 %
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise and Cognitive testingMaximal cardiopulmonary test Rest cognitive testing | Other | aged-gender matched healthy controls, patients with chronic heart failure, patients with coronary heart disease, patients with metabolic syndrome |
Primary outcome
Cerebral hemodynamics measured with near-infra red spectroscopy (NIRS)
Time frame: Measured within 2 weeks
Total haemoglobin (ΔtHb): index of brain perfusion (in µM) measured during maximal exercise test.
1 secondary outcome
Resting cognitive function (assessed by the battery test)
Time frame: Measured within 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: No. no IPD plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Nigam, M.D principal investigator
Montreal Heart Institute
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cognitive testing in people with Metabolic Syndrome and Coronary Artery Disease, run by Montreal Heart Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral hemodynamics measured with near-infra red spectroscopy (NIRS) (time frame: Measured within 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.