A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2011
End Date:September 2013

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A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (CAD)

The primary objective of the study is to assess the diagnostic efficacy (specificity and
sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to
single photon emission computed tomography (SPECT) MPI in the detection of significant
coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a
documented history of Myocardial Infarction (MI).

The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz
F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six
hundred and eighty evaluable patients will be enrolled and will undergo SPECT MPI and
Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to
undergo or have undergone prior ICA without intervention (being either positive or negative
for CAD).

Inclusion Criteria:

Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional
details.

Exclusion Criteria:

Women who are pregnant, lactating, or of child bearing potential who are not practicing
birth control.

Unstable cardiac status. History of coronary artery bypass graft. History of percutaneous
coronary intervention within the past six months. See protocol for additional details.
We found this trial at
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3550 Jerome Avenue
Bronx, New York 10467
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301 University Blvd
Galveston, Texas 77555
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
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Auburn, Maine 04210
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Beverly Hills, California 90211
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Boston, Massachusetts 02114
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1 Boston Medical Center Place
Boston, Massachusetts 02118
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Boynton Beach, Florida 33437
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171 Ashley Avenue
Charleston, South Carolina 29425
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1215 Lee St
Charlottesville, Virginia 22903
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2600 Clifton Ave
Cincinnati, Ohio 45267
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Columbus, Ohio 43214
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281 W. Lane Ave
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
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2799 W Grand Blvd
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3535 Southern Blvd
Kettering, Ohio 45429
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Kingsport, Tennessee 37660
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1153 Western Road
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Los Angeles, California 90095
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New Haven, Connecticut 6520
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630 W 168th St
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320 E North Ave
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3350 La Jolla Village Dr
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