Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No study intervention.
- Who it may be relevant to
- Registry conditions: Coronary Disease, Percutaneous Coronary Intervention, Exercise Test, Myocardial Perfusion Imaging. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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).
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.
Interventions
- Other No study intervention
The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care.
Primary outcome measures
- Repeat revascularization [Time frame: 5 years]
- Non-fatal myocardial infarction [Time frame: 5 years]
- Non-fatal stroke [Time frame: 5 years]
- Cardiovascular death [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Yale University School of Medicine - Section of Cardiology — New Haven
Publications
- Gitto, M., Saito Y., Schneider, M., Papoutsidakis, N., Ardito, S., McCarthy, M., Cristea, E., Lansky, A., Altin, E. (2020). Journal of the American College of Cardiology. Discrepancy Between Visually Assessed and Quantitative Coronary Angiography Derived Diameter Stenosis in a Cohort of Women with Stable Coronary Artery Disease, 75(11). https://www.onlinejacc.org/content/75/11_Supplement_1/178
- Gitto, M., Saito Y., Schneider, M., Papoutsidakis, N., Ardito, S., McCarthy, M., Cristea, E., Lansky, A., Altin, E. (2020). Journal of the American College of Cardiology. Quantitative Flow Ratio According to Three-Dimensional Quantitative Coronary Angiography Defined Severity of Stenosis in a Cohort of Women with Stable Coronary Artery Disease, 75(11). https://www.onlinejacc.org/content/75/11_Supp
Identifiers
NCT: NCT04599192 · 2000024865