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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Disease, Percutaneous Coronary Intervention, Exercise Test, Myocardial Perfusion Imaging, Cardiac Catheterization

Intervention / Treatment
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* Other: No study intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women Presenting with Cardiac Ischemia<br>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. | Other: No study intervention<br>* The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeat revascularization | Repeat revascularizations will be documented throughout the course of the 5 year follow up period | 5 years | 
| Non-fatal myocardial infarction | Non-fatal myocardial infarctions will be documented throughout the course of the 5 year follow up period | 5 years | 
| Non-fatal stroke | Non-fatal strokes will be documented throughout the course of the 5 year follow up period | 5 years | 
| Cardiovascular death | Cardiovascular related death will be documented throughout the course of the 5 year follow up period | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WOMEN FiRST, FFR in Women, iFR in Women