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 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 1:03 AM
NCT ID:
NCT03925493
Eligibility Criteria:
Inclusion Criteria:
* Patients who are referred with an eligible diagnosis to CR.
* Patients with myocardial infarction, percutaneous coronary intervention, or bypass surgery
Exclusion Criteria:
* Permanent Atrial fibrillation, as this would interfere with using a target heart rate range during cardiac rehabilitation.
* Patients with pacemakers, as the polar heart rate monitor interferes with pacing lines on the telemetry system.
* Stable angina, as chest pain could become a limiting factor as exercise training progresses, rather than using target heart rates.
* Patients with high risk unrevascularized coronary artery disease including left main coronary disease \>60% or proximal left anterior descending artery (LAD) \>80%, per the discretion of the medical director.
* Patients with heart transplant or left-ventricular assist device, as heart rates can be inaccurate and difficult to measure.
* Patients who plan to attend fewer than 12 sessions of CR, for reasons that might include need to return to work, high copays, transportation, lack of insurance, or lack of interest in the program.
* Patients who join the Baystate CR program after having completed more than 3 sessions of CR at a different CR program.
* Major orthopedic limitations to exercise, such as history of amputation or exercise-limiting joint pain, or inability to walk on a treadmill, because all patients will have to complete a stress test on a treadmill and objective data collected during CR will be recorded during treadmill exercise.
* Patients who plan to undergo a clinically indicated stress test in the next 3 months as this would potentially interfere with the exercise prescription in the control group.
* Any elective hospitalization or revascularization procedure (such as PCI or CABG) that are planned to occur in the next 3 months. These could interrupt exercise training or change target heart rate ranges.
* Any other condition in which exercise training or exercise testing would be contraindicated such as severe uncontrolled hypertension, diabetes, arrhythmia, or severe valvular disease, as determined by the Medical Director of Cardiac Rehabilitation.
* Any other condition that would prohibit adherence to study protocols, such as active drug use, or untreated mental health conditions that would interfere with following instructions.
* Patients judged to be at very high or high-risk of early drop-out, per current program risk stratification
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03925493
Study Brief:
Protocol Section:
NCT03925493