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:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT05611333
Eligibility Criteria:
Inclusion Criteria:
1\. Age 40-80 years 2. Female sex 3. Diagnosis of coronary artery disease that meets criteria for one of the following:
a. Stable obstructive CAD i. A history of myocardial infarction (MI) at least 12 months prior to enrollment, history of coronary artery bypass graft surgery (CABG), and/or history of percutaneous coronary intervention (PCI) with
1. Coronary angiogram completed at time of diagnosis with MI or completion of CABG/PCI AND
2. Stress test (completed within 12 months after diagnosis of MI OR within 5 years prior to enrollment) OR
3. Absence of anginal symptoms following revascularization ii. Previous imaging (e.g. coronary computed tomographic angiography \[CCTA\] or coronary angiography) demonstrating any stenosis 50% or greater in the left main coronary artery, 70% or greater in any other coronary artery, or both.
b. Non-obstructive CAD i. Previous imaging (e.g. CCTA or coronary angiography) with/without additional stress testing demonstrating coronary artery stenosis 1 to 49% in the left main coronary artery or 1-70% in any other epicardial coronary artery with or without stress testing negative for ischemia.
ii. Previous imaging (e.g. calcium scoring or conventional computed tomography) demonstrating calcified coronary artery plaque with or without stress testing negative for ischemia.
4. Completed visit with Mass General Brigham (MGB) cardiologist within 12 months prior to enrollment
5. Self-reported physical inactivity (any amount of PA less than guideline-recommended amount of 150 minutes/week of at least moderate intensity aerobic exercise)10 as reported on the brief "Exercise as a Vital Sign" (EVS) instrument11
6. Ability to ambulate independently
7. Possession of and ability to use a computer and/or smart device with video conferencing capability
8. Possession of and willing to use a home scale daily.
9. Willing to use a Fitbit activity tracker daily.
Exclusion Criteria:
1. A history of conditions that limit or contraindicate exercise (e.g., myocardial infarction within 48 hours, unstable angina, heart failure with reduced ejection fraction, severe aortic stenosis, uncontrolled cardiac arrhythmias, myocarditis, acute pulmonary embolism, severe pulmonary hypertension, aortic dissection, hypertrophic obstructive cardiomyopathy, hypertension greater than 200/110 mmHg, known obstruction of the left coronary artery)
2. Musculoskeletal or plantar wounds/injuries
3. Severe mental or cognitive disabilities
4. Inability to speak English
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05611333
Study Brief:
Protocol Section:
NCT05611333