Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy (FIRST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01153555
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : March 4, 2015
Information provided by (Responsible Party):
Volcano Corporation

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).

Condition or disease
Coronary Artery Disease

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.

Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy: The FIRST Study
Study Start Date : September 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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.

Primary Outcome Measures :
  1. Correlation between (Minimum Luminal Area) MLA and FFR [ Time Frame: Day of Procedure ]
    The correlation between MLA and FFR; and the threshold value for MLA corresponding to an FFR < 0.8.

Secondary Outcome Measures :
  1. Correlation between FFR and IVUS and VH parameters [ Time Frame: Day of Procedure ]
    Correlation between FFR and various IVUS measurements (MLA,area stenosis, lesion length, plaque burden) and VH parameters (plaque type and presence of a TCFA)

  2. Association of FFR and Cut-off of MLA [ Time Frame: Day of Procedure ]
    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%

  3. Identify risk score model [ Time Frame: 1 year ]
    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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01153555

United States, District of Columbia
Washingtoon Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Volcano Corporation
Principal Investigator: Ron Waksman, MD Washington Hospital Center

Publications of Results:
Responsible Party: Volcano Corporation Identifier: NCT01153555     History of Changes
Other Study ID Numbers: FIRST
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases