- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03018561
Brain, Cardiac Hemodynamics and Cognition During Exercise in Subjects With Various Cardiovascular Profiles (COGNEX)
30. januar 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
140
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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
|
Eksperimentel: 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
|
Eksperimentel: 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
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cerebral hemodynamics measured with near-infra red spectroscopy (NIRS)
Tidsramme: Measured within 2 weeks
|
Total haemoglobin (ΔtHb): index of brain perfusion (in µM) measured during maximal exercise test.
|
Measured within 2 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Resting cognitive function (assessed by the battery test)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Anil Nigam, M.D, Montreal Heart Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2011
Primær færdiggørelse (Faktiske)
15. januar 2018
Studieafslutning (Faktiske)
15. januar 2018
Datoer for studieregistrering
Først indsendt
6. december 2016
Først indsendt, der opfyldte QC-kriterier
10. januar 2017
Først opslået (Skøn)
12. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- COGNEX-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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IPD-planbeskrivelse
no IPD plan
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