Clinical trial NCT04599192: Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Coronary Disease
Percutaneous Coronary Intervention
Exercise Test
Myocardial Perfusion Imaging
Cardiac Catheterization
Keywords: WOMEN FiRST
FFR in Women
iFR in Women
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients (\>18 years of age) presenting with suspected myocardial ischemia or acute coronary syndrome for evaluation of ischemia by non-invasive stress testing and coronary angiography.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Repeat revascularization
timeFrame: 5 years
measure: Non-fatal myocardial infarction
timeFrame: 5 years
measure: Non-fatal stroke
timeFrame: 5 years
measure: Cardiovascular death
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine - Section of Cardiology
state: Connecticut
Study officials:
affiliation: Yale University
name: Elissa Altin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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_Supplement_1/177