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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT02591758
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent form
2. Patient 18 years of age
3. History of coronary artery disease that consists of a well-documented medical history (over 3 months prior to the enrolment) of myocardial infarction or significant coronary artery disease with non-invasive angiographic confirmation.
4. Symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ECG) changes.
5. All-comers with stable or unstable moderate-to-severe angina pectoris (Canadian Cardiovascular Class \[CCS\] II-III or IV subsequently medically stabilized (minimum 7 days) despite guideline directed medical therapy due to a reversible myocardial ischemia deemed sufficiently severe to justify a coronary angiography.
6. Patient can be treated percutaneously, surgically or medically.
7. Willing to undertake a cardiac rehabilitation program at home
8. Patient understands the nature of the device and is able to wear the Hexoskin for 24h Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
Exclusion Criteria:
1. Recent (\<1 week) acute coronary syndrome
2. Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the 3 months prior to screening.
3. Severe valvular disease
4. High-risk criteria demonstrated on the treadmill stress test (Appendix D5)
5. With contraindications to, unable to, or with other co-morbidities that may prevent or interfere with the ability to perform treadmill stress test (including but not limited to : pulmonary hypertension, functionally limiting chronic obstructive pulmonary disease (COPD), history of pulmonary tuberculosis, prior hospitalization for acute exacerbation of chronic lung disease, home oxygen use, chronic oral steroid therapy that can limit exercise capacity, functionally limiting peripheral artery disease.
6. Patients for whom an home-based cardiac rehabilitation is contraindicated or not possible
7. Left ventricular ejection fraction (LVEF) \< 40% or patients with defibrillator or cardiac resynchronisation pacemaker.
8. Severe left ventricular (LV) hypertrophy (defined as septal wall thickness at echocardiography of more than \> 13 mm)
9. Congenital cardiac defects, severe uncontrolled hypertension (seated systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mm Hg), severe anemia, suspected or known dissecting aortic aneurysm, acute myocarditis or pericarditis, thrombophlebitis or pulmonary embolism.
10. Presence of electrocardiographic or other abnormalities/factors that could interfere with exercise electrocardiograph interpretation or may lead to a false positive stress test (See appendix B for more details)
11. Clinically significant arrhythmias, rapid atrial fibrillation (\> 110 beats per minute at rest) or atrioventricular conduction block greater than first degree.
12. Planned need for concomitant cardiac surgery, such as valve surgery.
13. Refusal or an inability to perform cardiac rehabilitation.
14. Moribund patients, or patients with comorbidities limiting life expectancy \< 1 year.
15. Any contra-indications to the treadmill stress test (See Appendix D6)
16. Mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent.
17. Potential for non-compliance towards the requirements in the study protocol and/or follow-up visits
18. Any other conditions that, in the opinion of the investigator, are likely to prevent compliance with the study protocol or pose a safety concern if the subject participates in the study.
19. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02591758
Study Brief:
Protocol Section:
NCT02591758