Clinical trial NCT01153555: Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy
Official title: Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy: The FIRST Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Sign written informed consent to participate in the study.
* Clinical indication for coronary angiography for stable or unstable angina

Specific Angiographic Inclusion Criteria:

* 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)
* The vessel(s) with the intermediate lesion must have no flow limiting lesions and must be available for imaging and must be considered safe for imaging evaluation.

Exclusion Criteria:

* Patient has had a documented acute ST-segment elevation myocardial infarction within the past 24 hours
* Decompensated heart failure or hypotension requiring intubation, inotropes, intravenous diuretics or intraaortic balloon counterpulsation.
* Renal dysfunction (creatinine clearance \< 60 mL/min/1.73m2)
* Pregnancy or breast-feeding
* Standard contra-indications to MRI for implanted ferro-magnetic devices - i.e.: pacemakers, defibrillator (AICD), and aneurysm clips
* Body weight \> 400lbs
* Left ventricular hypertrophy \>1.5cm by by echocardiogram
* History of bronchospasm or asthma
* ECG evidence of conduction defect, including 2nd or 3rd degree AVB
* Patient has a known hypersensitivity, allergy or contraindication to gadolinium-based contrast agents.
* Prior participation in this study or patient is currently enrolled in another investigational use device or drug study that has not reached its primary endpoint. If the patient is enrolled in another study that is not investigational, required visits for that trial must not interfere with the conduct of this trial.

Angiographic Exclusion Criteria:

* Unprotected left main lesion location.
* Ostial lesion
* Angiographic evidence of severe calcification or marked tortuosity of the target vessel that would preclude safe imaging
* Lesion is located within or distal to an arterial or saphenous vein graft.
* Angiographic presence of thrombus in the lesion or vessel studied.
* Lesion in a vessel with \<2.5 mm reference diameter or with more than one lesion in the vessel

Primary outcomes:
measure: Correlation between (Minimum Luminal Area) MLA and FFR
timeFrame: Day of Procedure
Secondary outcomes:
measure: Correlation between FFR and IVUS and VH parameters
timeFrame: Day of Procedure
measure: Association of FFR and Cut-off of MLA
timeFrame: Day of Procedure
measure: Identify risk score model
timeFrame: 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washingtoon Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.