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

Not Applicable

Completed

• Conditions: Heart Failure; Metabolic Syndrome; Coronary Artery Disease
• Interventions: Other: Exercise and Cognitive testing

• Registration Number: NCT03018561
• Lead Sponsor: Montreal Heart Institute

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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aged-gender matched healthy controls	Exercise and Cognitive testing	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.
patients with coronary heart disease	Exercise and Cognitive testing	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 chronic heart failure	Exercise and Cognitive testing	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.
patients with metabolic syndrome	Exercise and Cognitive testing	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.

Primary Outcome Measures

Name	Time	Method
Cerebral hemodynamics measured with near-infra red spectroscopy (NIRS)	Measured within 2 weeks	Total haemoglobin (ΔtHb): index of brain perfusion (in µM) measured during maximal exercise test.

Secondary Outcome Measures

Name	Time	Method
Resting cognitive function (assessed by the battery test)	Measured within 2 weeks	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.)