Prospective Evaluation of Coronary Artery Disease in Women Presenting With Cardiac Ischemia: an Anatomic and Physiologic Study Comparing Fractional Flow Reserve (FFR) and Instantaneous Free-wave Ratio (iFR) on Cardiac Catheterization With Findings of Inducible Ischemia on Non-invasive Stress Imaging
| Registry | NCT04599192, acronym FiRST |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 500 (Estimated) |
| Sponsor | Yale University (Other) |
| Conditions | Coronary Disease, Percutaneous Coronary Intervention, Exercise Test, Myocardial Perfusion Imaging, Cardiac Catheterization |
| Interventions | No study intervention (Other) |
| Dates | start 2019-04-19, primary completion 2028-08-01 (estimated), completion 2028-08-01 (estimated), first posted 2020-10-22, last updated 2026-09-04 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Coronary Disease All trials for Percutaneous Coronary Intervention All trials of No study intervention
A real world study to evaluate outcomes in women based on guideline identified fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) cutoffs for ischemia (ischemia defined as FFR ≤ 0.80 and iFR ≤ 0.89).
The WOMEN FiRST (FFR iFR Revascularization Strategies Trial) study collects information from enrolled subjects to create a data repository. The data will be used to further elucidate recommendations for PCI of angiographically intermediate lesions (30-90% stenosis) in epicardial lesions in women by comparing FFR and iFR findings to findings of inducible ischemia on existing non-invasive stress imaging studies. Gender comparisons will also be made from archived and published research data sets from studies comprised up to 80% men. Data will also be stored long term for use in future undefined analyses.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Women Presenting with Cardiac Ischemia | Other: No study intervention | Women presenting with cardiac ischemia as indicated by standard of care non-invasive stress testing with cardiac magnetic resonance (CMR), SPECT myocardial perfusion, and PET myocardial perfusion imaging. This cohort of women must also meet the clinical criteria to undergo coronary angiography. Women may be approached for consent either before or after their coronary angiography procedure. |
Sex: Female, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Yale University School of Medicine - Section of Cardiology | New Haven, Connecticut | United States |