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

NCT04599192 | Enrolling By Invitation DMC

• 1 other identifier: 2000024865
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

WOMEN FiRST; FFR in Women; iFR in Women

Outcome Measures

Primary Outcomes (4)

• Repeat revascularization

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

  5 years

• Non-fatal myocardial infarction

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

  5 years

• Non-fatal stroke

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

  5 years

• Cardiovascular death

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

  5 years

Study Arms (1)

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.

Other: No study intervention

Interventions

No study intervention OTHER

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

Women Presenting with Cardiac Ischemia

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility is not based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University School of Medicine - Section of Cardiology

New Haven, Connecticut, 06520, United States

Location

Related 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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Elissa Altin, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: October 22, 2020
• Study Start: April 19, 2019
• Primary Completion: April 10, 2026
• Study Completion (Estimated): April 30, 2029
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)