Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:40 PM
Ignite Modification Date:
2025-12-24 @ 12:40 PM
NCT ID:
NCT02715661
Eligibility Criteria:
Inclusion Criteria:
Coronary Artery Disease
* inclusion age range is 45-80 years of age
* both female and male participants are being studied
* upon discharge from hospital, are referred into Cardiac Rehabilitation (CR) programs in London. Prospective able to read \& write English
* living in private residence
* under the care of a family physician, having been discharged from hospital following admission for acute coronary syndrome (e.g. ST elevation or non ST elevation MI), angina, per cutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as documented by the attending physician.
* Coronary artery disease patients who were not eligible for cardiac rehabilitation or who were referred to CR but have declined (by not enrolling or attending CR) will be invited as Usual Care (CADuc) Coronary artery disease Subjects.
Metabolic Syndrome Group:
* inclusion age range is 45-80 years of age
* both female and male participants are being studied
* Systolic Blood Pressure\>130 and/or Diastolic Blood Pressure\>85 mmHg
* any two of the following criteria:
* Abdominal obesity (waist circumference \>102cm in males;\>88cm in females), Fasting triglycerides \> 1.695 mmol/L, Low HDL cholesterol: Males \< 1.04 mmol/L; Females \< 1.29 mmol/L, Fasting glucose \>5.60 mmol/L
* able to read \& write English
* living in private residence
Healthy Control Group
* the inclusion age range is 18-80 years of age
* both female and male participants are being studied
* Control individuals will have no diagnosis of cardiac, vascular, metabolic, inflammatory or neurological disease, and have not been on any medication for such conditions in the past 12 months able to read \& write English
* living in private residence
Exclusion Criteria:
* As magnetic resonance imaging (MRI) is used to examine the brain in this study, participants will not be included in the study if they have any history of head or eye injury involving metal fragments, some type of implanted electrical device (such as a cardiac pacemaker). If they have severe heart disease (including susceptibility to heart rhythm abnormalities), they should not have an MRI scan unless supervised by a physician. Additionally they should not have a MRI scan if they have conductive implants or devices such as skin patches, body piercing or tattoos containing metallic inks because there is a risk of heating or induction of electrical currents within the metal element causing burns to adjacent tissue. In addition to these guidelines, patients with claustrophobia will not be studied in the MRI elements of this project.
* respiratory disease
* a history of psychosis
* eating disorders
* manic or bipolar disorder
* major psychiatric conditions
* immunological, congenital or neurodegenerative disorders (e.g., Raynaud's syndrome, multiple sclerosis, Parkinson's Disease, ALS),
* dependence on alcohol or drugs within the past year
* who smoke (within the past five years)
* women who are pregnant or trying to become pregnant will also be excluded
* participants will be excluded if they are unable to provide written informed consent, or to complete questionnaires or health history forms due to language or cognitive difficulties
* coronary artery disease Subjects will be excluded if they have:
* unstable heart rhythm
* congenital coronary abnormality
* cardiomyopathy
* severe congestive heart failure
* 2°-3° atrioventricular block
* more than 2 M.I.s
* major arrhythmias such as atrial fibrillation or more than 4 ectopic beats/min, sick sinus syndrome, or are scheduled to undergo PCI or CABG within 2 months following hospital discharge
* all healthy Control and Metabolic Syndrome participants will provide clearance from their Family Physician to participate in exercise training on the Physical Activity Readiness Questionnaire (PARQ) Form.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02715661
Study Brief:
Protocol Section:
NCT02715661