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Active Not Recruiting
NCT04599192
Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women
Conditions: Coronary Disease, Percutaneous Coronary Intervention, Exercise Test, Myocardial Perfusion Imaging, Cardiac Catheterization
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 500
Sponsor: Yale University
Location: Yale University School of Medicine - Section of Cardiology New Haven Connecticut
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).
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 \
Source: ClinicalTrials.gov (NCT04599192). StuddyBuddy aggregates publicly available trial information.