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Phase Pilot

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

  • Study HIC#:2000024865REG
  • Last Updated:11/13/2023

The aim of this data repository is to evaluate the impact of gender differences on fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). These findings will be used to refine the recommendations of the role of physiologic assessment using FFR and iFR-guided percutaneous coronary interventions (PCI) in women. Data will be stored long term for future undefined analyses, including outcomes in women presenting with ischemic syndromes. Gender comparisons will made from archival and published research data sets from studies comprised up to 80% men.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Scott Ardito

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    Trial Purpose and Description

    The aim of this data repository is to evaluate the impact of gender differences on fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). These findings will be used to refine the recommendations of the role of physiologic assessment using FFR and iFR-guided percutaneous coronary interventions (PCI) in women. Data will be stored long term for future undefined analyses, including outcomes in women presenting with ischemic syndromes. Gender comparisons will made from archival and published research data sets from studies comprised up to 80% men.

    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

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: