Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women
Enrolling by invitation
Conditions studied: Coronary Disease, Percutaneous Coronary Intervention, Exercise Test, Myocardial Perfusion Imaging, Cardiac Catheterization
In brief
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).
Key facts
- Study ID
- NCT04599192
- Run by
- Yale University
- People needed
- 500
- Starts
- 2019-04-19
- Expected to finish
- 2029-04-30
- Last updated by the study team
- 2025-11-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female ≥ 18 years old at signing of informed consent
- Suspected myocardial ischemia or acute coronary syndrome
- Indication for non-invasive perfusion imaging study
- Indication for diagnostic catheterization
- Eligible for PCI
- Signed informed clinical procedural consent by subject or by surrogate
You may not qualify if…
- Inability to receive adenosine or regadenoson (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker.
- Severe cardiomyopathy (ejection fraction <30%)
- Extremely tortuous or calcified coronary arteries precluding FFR/iFR measurements
- Patients with left main coronary artery disease requiring revascularization
- Female of child baring age should have negative pregnancy test
- Subject is pregnant or breast feeding, or planning to become pregnant
- 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
- ICD or PPM
Where it is running
- Yale University School of Medicine - Section of Cardiology — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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