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

N/AEnrolling By InvitationNCT04599192

Yale University500 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

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

Interventions

No study interventionOTHER

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale University School of Medicine - Section of Cardiology

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Repeat revascularization

Repeat revascularizations will be documented throughout the course of the 5 year follow up period

Time frame: 5 years

Non-fatal myocardial infarction

Non-fatal myocardial infarctions will be documented throughout the course of the 5 year follow up period

Time frame: 5 years

Non-fatal stroke

Non-fatal strokes will be documented throughout the course of the 5 year follow up period

Time frame: 5 years

Cardiovascular death

Cardiovascular related death will be documented throughout the course of the 5 year follow up period

Time frame: 5 years

Data from ClinicalTrials.gov

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