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

Sponsor

Yale University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04599192

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Apr 19, 2019

Anticipated Primary Completion Date :

Apr 19, 2023

Anticipated Study Completion Date :

Apr 19, 2023

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

Repeat revascularization [5 years]
Repeat revascularizations will be documented throughout the course of the 5 year follow up period
Non-fatal myocardial infarction [5 years]
Non-fatal myocardial infarctions will be documented throughout the course of the 5 year follow up period
Non-fatal stroke [5 years]
Non-fatal strokes will be documented throughout the course of the 5 year follow up period
Cardiovascular death [5 years]
Cardiovascular related death will be documented throughout the course of the 5 year follow up period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine - Section of Cardiology	New Haven	Connecticut	United States	06520

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Elissa Altin, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Yale University

ClinicalTrials.gov Identifier:

NCT04599192

Other Study ID Numbers:

2000024865

First Posted:

Oct 22, 2020

Last Update Posted:

Nov 3, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yale University

WOMEN FiRST

FFR in Women

iFR in Women

Additional relevant MeSH terms:

Coronary Disease

Study Results

No Results Posted as of Nov 3, 2021