NCT04599192Active, not recruiting
Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 12 Aug 2020
- Start date
- 19 Apr 2019
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Yale University
- Diseases
- Coronary artery disease
- NCT number
- NCT04599192
What you commit to
- Study type: Observational
- Planned participants: 500
- From 19 Apr 2019 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to receive adenosine or regadenoson (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker.
- Patients with left main coronary artery disease requiring revascularization
Lab values
- Severe cardiomyopathy (ejection fraction \<30%)
- 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
Age
- Female of child baring age should have negative pregnancy test
Other
- Extremely tortuous or calcified coronary arteries precluding FFR/iFR measurements
- Subject is pregnant or breast feeding, or planning to become pregnant
- ICD or PPM
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale University School of Medicine - Section of Cardiology Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.