Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women

Launched by YALE UNIVERSITY · Oct 16, 2020

Keywords

ClinConnect Summary

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 undefine...

Gender

FEMALE

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