Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women
- Conditions
- Exercise TestCoronary DiseaseMyocardial Perfusion ImagingCardiac CatheterizationPercutaneous Coronary Intervention
- Registration Number
- NCT04599192
- Lead Sponsor
- Yale University
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Non-fatal myocardial infarction 5 years Non-fatal myocardial infarctions will be documented throughout the course of the 5 year follow up period
Non-fatal stroke 5 years Non-fatal strokes will be documented throughout the course of the 5 year follow up period
Repeat revascularization 5 years Repeat revascularizations will be documented throughout the course of the 5 year follow up period
Cardiovascular death 5 years Cardiovascular related death will be documented throughout the course of the 5 year follow up period
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Yale University School of Medicine - Section of Cardiology
🇺🇸New Haven, Connecticut, United States
Yale University School of Medicine - Section of Cardiology🇺🇸New Haven, Connecticut, United States