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

Coronary Disease Clinical Trial

— FiRST  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04599192
• Other study ID #: 2000024865
• Status: Enrolling by invitation
• Start date: April 19, 2019
• Est. completion date: April 19, 2025

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: April 19, 2025
• Est. primary completion date: April 19, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• No study intervention
The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care.

Locations

Country	Name	City	State
United States	Yale University School of Medicine - Section of Cardiology	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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_Supplement_1/177

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeat revascularization	Repeat revascularizations will be documented throughout the course of the 5 year follow up period	5 years
Primary	Non-fatal myocardial infarction	Non-fatal myocardial infarctions will be documented throughout the course of the 5 year follow up period	5 years
Primary	Non-fatal stroke	Non-fatal strokes will be documented throughout the course of the 5 year follow up period	5 years
Primary	Cardiovascular death	Cardiovascular related death will be documented throughout the course of the 5 year follow up period	5 years