Brain, Cardiac Hemodynamics and Cognition During Exercise in Subjects With Various Cardiovascular Profiles

NCT03018561 | Completed

• 1 other identifier: COGNEX-1
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Metabolic Syndrome; Coronary Artery Disease; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Cerebral hemodynamics measured with near-infra red spectroscopy (NIRS)

  Total haemoglobin (ΔtHb): index of brain perfusion (in µM) measured during maximal exercise test.

  Measured within 2 weeks

Secondary Outcomes (1)

• Resting cognitive function (assessed by the battery test)

  Measured within 2 weeks

Study Arms (4)

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.

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.

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).

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.

Other: Exercise and Cognitive testing

Interventions

Exercise and Cognitive testing OTHER

Maximal cardiopulmonary test Rest cognitive testing

aged-gender matched healthy controls; patients with chronic heart failure; patients with coronary heart disease; patients with metabolic syndrome

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• ≥18 years
• Left ventricular ejection fraction (LVEF) \<40% (measured within 6 months of their enrolment by MUGA 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.

You may not qualify if:

• For healthy subjects:
• lack of expressed written consent
• metabolic syndrome
• 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 MetS:
• lack of expressed written consent
• coronary heart disease
• chronic systolic heart failure

Sponsors & Collaborators

• Montreal Heart Institute: lead

MeSH Terms

Conditions

Metabolic Syndrome; Coronary Artery Disease; Heart Failure

Interventions

Exercise; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Anil Nigam, M.D

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: January 12, 2017
• Study Start: January 1, 2011
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share