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This is a multi-center, prospective registry of patients with intermediate coronary lesions defined as a stenosis of 40-80% by angiography. Approximately 300 patients will be enrolled into the study at sites in the United States and Europe. There will be no follow up beyond hospital discharge in this study. A sub-group of 30 patients will undergo Adenosine MRI. The investigators hypothesize that Intravascular Ultrasound Radiofrequency (IVUS RF) anatomical criteria, such as minimal luminal area, plaque burden and virtual histology plaque type, can predict physiological ischemia by Fractional Flow Reserve (FFR).
Patients undergoing cardiac catheterization must meet clinical inclusion and exclusion criteria and sign an informed consent. At the time of catheterization the patients will be further analyzed for eligibility using angiographic inclusion and exclusion criteria. Patients who fulfilled the clinical and angiographic criteria will undergo further imaging evaluation using an IVUS RF catheter (Volcano Therapeutics) and FFR wire (Radi or Volcano). The decision for treatment of any lesion will be at the operator's discretion. For patients enrolled at Washington Hospital Center and do not undergo percutaneous coronary intervention, an assessment with non invasive perfusion adenosine MRI also be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermediate coronary lesions | Diagnostic device: FFR Diagnostic device: IVUS RF At participating centers, FFR and IVUS are standard of care diagnostic procedures for patients with intermediate (40-80% angiographic stenosis by visual estimate). Both modalities were used regularly for such patients whether or not they are participants in this clinical study. In FIRST, the decision to perform percutaneous coronary intervention (PCI) was left to the discretion of the investigator, and was not dictated by the clinical protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between (Minimum Luminal Area) MLA and FFR | The correlation between MLA and FFR; and the threshold value for MLA corresponding to an FFR < 0.8. | Day of Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between FFR and IVUS and VH parameters | Correlation between FFR and various IVUS measurements (MLA,area stenosis, lesion length, plaque burden) and VH parameters (plaque type and presence of a TCFA) | Day of Procedure |
| Association of FFR and Cut-off of MLA |
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Inclusion Criteria:
Specific Angiographic Inclusion Criteria:
Exclusion Criteria:
Angiographic Exclusion Criteria:
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Patients required to have an intermediate coronary lesion (stenosis 40-80% by visual estimate) in one or more native, major epicardial coronary artery with reference diameter ≥2.5mm (visual estimate)
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| Name | Affiliation | Role |
|---|---|---|
| Ron Waksman, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washingtoon Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23352786 | Result | Waksman R, Legutko J, Singh J, Orlando Q, Marso S, Schloss T, Tugaoen J, DeVries J, Palmer N, Haude M, Swymelar S, Torguson R. FIRST: Fractional Flow Reserve and Intravascular Ultrasound Relationship Study. J Am Coll Cardiol. 2013 Mar 5;61(9):917-23. doi: 10.1016/j.jacc.2012.12.012. Epub 2013 Jan 23. |
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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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Assess the association between FFR <0.75 and 0.8 and determined cut-off of MLA with presence of a Thin Cap Fibro-Atheroma(TCFA) and/or plaque burden ≥70% |
| Day of Procedure |
| Identify risk score model | To identify a risk score model taking into account IVUS measurements (MLA, plaque burden, area stenosis, lesion length) and VH parameters (plaque type and presence of TCFA) associated with FFR < 0.8 | 1 year |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |