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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04599192
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2020
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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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).

Condition or disease Intervention/treatment
Coronary Disease Percutaneous Coronary Intervention Exercise Test Myocardial Perfusion Imaging Cardiac Catheterization Other: No study intervention

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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
Actual Study Start Date : April 19, 2019
Estimated Primary Completion Date : April 19, 2023
Estimated Study Completion Date : April 19, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care.


Outcome Measures
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Primary Outcome Measures :
  1. Repeat revascularization [ Time Frame: 5 years ]
    Repeat revascularizations will be documented throughout the course of the 5 year follow up period

  2. Non-fatal myocardial infarction [ Time Frame: 5 years ]
    Non-fatal myocardial infarctions will be documented throughout the course of the 5 year follow up period

  3. Non-fatal stroke [ Time Frame: 5 years ]
    Non-fatal strokes will be documented throughout the course of the 5 year follow up period

  4. Cardiovascular death [ Time Frame: 5 years ]
    Cardiovascular related death will be documented throughout the course of the 5 year follow up period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is not based on self-representation of gender identity
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599192


Locations
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United States, Connecticut
Yale University School of Medicine - Section of Cardiology
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Elissa Altin, MD Yale University
More Information
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Additional Information:

Publications:
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

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04599192    
Other Study ID Numbers: 2000024865
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale University:
WOMEN FiRST
FFR in Women
iFR in Women
Additional relevant MeSH terms:
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Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases