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- Klinische proef NCT03018561
Brain, Cardiac Hemodynamics and Cognition During Exercise in Subjects With Various Cardiovascular Profiles (COGNEX)
30 januari 2018 bijgewerkt door: Montreal Heart Institute
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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
140
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria
- 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)
- 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.
Exclusion criteria
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
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: aged-gender matched healthy controls
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.
|
Maximal cardiopulmonary test Rest cognitive testing
|
Experimenteel: patients with metabolic syndrome
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.
|
Maximal cardiopulmonary test Rest cognitive testing
|
Experimenteel: patients with coronary heart disease
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).
|
Maximal cardiopulmonary test Rest cognitive testing
|
Experimenteel: patients with chronic heart failure
Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria:
|
Maximal cardiopulmonary test Rest cognitive testing
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Cerebral hemodynamics measured with near-infra red spectroscopy (NIRS)
Tijdsspanne: Measured within 2 weeks
|
Total haemoglobin (ΔtHb): index of brain perfusion (in µM) measured during maximal exercise test.
|
Measured within 2 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Resting cognitive function (assessed by the battery test)
Tijdsspanne: 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.)
|
Measured within 2 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Anil Nigam, M.D, Montreal Heart Institute
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2011
Primaire voltooiing (Werkelijk)
15 januari 2018
Studie voltooiing (Werkelijk)
15 januari 2018
Studieregistratiedata
Eerst ingediend
6 december 2016
Eerst ingediend dat voldeed aan de QC-criteria
10 januari 2017
Eerst geplaatst (Schatting)
12 januari 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 januari 2018
Laatste update ingediend die voldeed aan QC-criteria
30 januari 2018
Laatst geverifieerd
1 januari 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Myocardiale ischemie
- Hartziekten
- Hart-en vaatziekten
- Vaatziekten
- Glucosemetabolismestoornissen
- Metabole ziekten
- Arteriosclerose
- Arteriële occlusieve ziekten
- Ziekte
- Insuline-resistentie
- Hyperinsulinisme
- Hart-en vaatziekte
- Hartfalen
- Coronaire hartziekte
- Syndroom
- Metaboolsyndroom
Andere studie-ID-nummers
- COGNEX-1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
no IPD plan
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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