Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy (FIRST)
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).
Coronary Artery Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy: The FIRST Study|
- Correlation between (Minimum Luminal Area) MLA and FFR [ Time Frame: Day of Procedure ] [ Designated as safety issue: No ]The correlation between MLA and FFR; and the threshold value for MLA corresponding to an FFR < 0.8.
- Correlation between FFR and IVUS and VH parameters [ Time Frame: Day of Procedure ] [ Designated as safety issue: No ]Correlation between FFR and various IVUS measurements (MLA,area stenosis, lesion length, plaque burden) and VH parameters (plaque type and presence of a TCFA)
- Association of FFR and Cut-off of MLA [ Time Frame: Day of Procedure ] [ Designated as safety issue: No ]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%
- Identify risk score model [ Time Frame: 1 year ] [ Designated as safety issue: No ]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
|Study Start Date:||September 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153555
|United States, District of Columbia|
|Washingtoon Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Ron Waksman, MD||Washington Hospital Center|