Cardiac Catheterization, Coronary Disease, Exercise Test, Myocardial Perfusion Imaging, Percutaneous Coronary Intervention
Conditions
Keywords
WOMEN FiRST, FFR in Women, iFR in Women
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).
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.
Interventions
The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care.
Sponsors
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElissa Altin, MD
Yale University
Outcome results
None listed