By InvitationNot Applicable

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

United States500 participantsStarted 2019-04-19

Plain-language 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).

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Repeat revascularization

Timeframe: 5 years

Non-fatal myocardial infarction

Timeframe: 5 years

Non-fatal stroke

Timeframe: 5 years

Cardiovascular death

Timeframe: 5 years

Trial details

NCT IDNCT04599192

SponsorYale University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04-10

View on ClinicalTrials.gov More Coronary Disease trials

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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