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

• Conditions: Exercise Test; Coronary Disease; Myocardial Perfusion Imaging; Cardiac Catheterization; Percutaneous Coronary Intervention
• Interventions: Other: No study 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-19
• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-04-19
• Study Completion: 2025-04-19

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women Presenting with Cardiac Ischemia	No study intervention	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.

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

Trial Locations

Locations (1)

Yale University School of Medicine - Section of Cardiology; 🇺🇸 New Haven, Connecticut, United States