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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04599192
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Apr 19, 2019
Status verified
Nov 2025
Primary completion
Apr 10, 2026
Completion
Apr 30, 2029

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Repeat revascularization [ Time Frame: 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of Medicine - Section of CardiologyNew HavenConnecticut06520-

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Yale University School of Medicine - Section of Cardiology· New Haven, CT

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