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 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT04599192
Eligibility Criteria:
Inclusion Criteria:
1. Female ≥ 18 years old at signing of informed consent
2. Suspected myocardial ischemia or acute coronary syndrome
3. Indication for non-invasive perfusion imaging study
4. Indication for diagnostic catheterization
5. Eligible for PCI
6. Signed informed clinical procedural consent by subject or by surrogate
Exclusion Criteria:
1. Inability to receive adenosine or regadenoson (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker.
2. Severe cardiomyopathy (ejection fraction \<30%)
3. Extremely tortuous or calcified coronary arteries precluding FFR/iFR measurements
4. Patients with left main coronary artery disease requiring revascularization
5. Female of child baring age should have negative pregnancy test
6. Subject is pregnant or breast feeding, or planning to become pregnant
7. Contraindication to non-invasive stress imaging including severe claustrophobia, renal disease with GFR \<30 where CMR is indication, any metal in the body which is a contraindication to CMR, allergy to gadolinium contrast
8. ICD or PPM
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04599192
Study Brief:
Protocol Section:
NCT04599192