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IRB Approval expired on 05/28/09 as it was pilot study. A new study was later initiated once VA Merit Review Grant (I01CX000342-01) was received. Thus a new IRB (10-05-05-02) and clinicaltrials.gov (NCT01719016) were initiated in place of this study.
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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Newly developed diagnostic parameters have potential to differentiate between epicardial disease and microvascular dysfunction with the help of anatomical details and physiological endpoints and can be used in present clinical settings.
The pressure drop coefficient (CDP) is a functional index based on hyperemic dp and u measurements. The lesion flow coefficient (LFC) combines the functional index CDP with an atomic measure (percentage area stenosis) as a single parameter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDP LFC | all patients will have this calculation based upon diagnostic parameters with IVUS and FFR and/or CFR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR/CFR and IVUS | Device | All patients with clinical indication for cardiac cath will have FFR and IVUS |
|
| Measure | Description | Time Frame |
|---|---|---|
| to detect ischemic heart disease in patients with abnormal stress tests using MPI with SPECT and to determine the presence of significant epicardial stenosis using coronary angiography with simultaneous physiological pressure and flow measurements | Upon Diagnostic Angiogram and Flow Wire |
| Measure | Description | Time Frame |
|---|---|---|
| To compare novel measurements, Pressure Drop Coefficient (CDP) & Lesion Flow Coefficient (LFC), against measured current parameters called Fractional flow reserve (FFR) & Coronary flow reserve (CFR). | Upon Diagnostic Angiogram and Flow Wire |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chest pain and suspected ischemia that needs to be assessed by a stress test
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Effat, MD | University of Cincinnati | Principal Investigator |
| Kranthi K Kolli, MS | University of Cincinnati | Principal Investigator |
| Massoud Leesar, MD | University of Cincinnati | Principal Investigator |
| Rupak Banerjee, PhD | University of Cincinnati | Principal Investigator |
| Tarek Helmy, MD | University of Cincinnati | Principal Investigator |
| Srikara Pellukhana, BS | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Cincinnati | Ohio | 45219 | United States | ||
| Department of Veterans Affairs |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Cincinnati |
| Ohio |
| 45220 |
| United States |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |