Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No study intervention | Other | The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Repeat revascularization | Repeat revascularizations will be documented throughout the course of the 5 year follow up period | 5 years |
| Non-fatal myocardial infarction | Non-fatal myocardial infarctions will be documented throughout the course of the 5 year follow up period | 5 years |
| Non-fatal stroke | Non-fatal strokes will be documented throughout the course of the 5 year follow up period | 5 years |
| Cardiovascular death | Cardiovascular related death will be documented throughout the course of the 5 year follow up period | 5 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participant eligibility is not based on self-representation of gender identity
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elissa Altin, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine - Section of Cardiology | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided