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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-19

Study Completion Date

2029-04-30

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).

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women Presenting with Cardiac Ischemia

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.

No study intervention

Intervention Type OTHER

The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care.

Interventions

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No study intervention

The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care.

Intervention Type OTHER

Eligibility Criteria

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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 \<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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No