Fractional Flow Reserve and Intravascular Ultrasound RelationShip STudy

NCT01153555 | Completed

• 1 other identifier: FIRST
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Correlation between FFR and IVUS and VH parameters

  Day of Procedure

• Association of FFR and Cut-off of MLA

  Day of Procedure

• Identify risk score model

  1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Volcano Corporation: lead

Study Sites (1)

Washingtoon Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• 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.

  PMID: 23352786 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: June 30, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 4, 2015

Record last verified: 2015-01

Locations

US (1)