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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Wyomissing, Pennsylvania 19610
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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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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Aventura, Florida 33180
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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
617.638.8000
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Boynton Beach, Florida 33437
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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1100
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Columbia, Missouri 65201
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Columbus, Ohio 43214
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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Fort Myers, Florida 33907
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Grand Rapids, Michigan 49503
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Hattiesburg, Mississippi 39401
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Jacksonville, Florida 32216
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Jerseyville, Illinois 62052
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Kansas City, Missouri 64111
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Katy, Texas 77493
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Kingsport, Tennessee 37660
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Knoxville, Tennessee 37909
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Lake Mary, Florida 32746
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Las Vegas, Nevada 89113
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1153 Western Road
London, Ontario N6G 1G6
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Los Angeles, California 90073
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Los Angeles, California 90033
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Los Angeles, California 90095
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Louisville, Kentucky 40205
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Mobile, Alabama 36608
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Mount Clemens, Michigan 48043
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Nashville, Tennessee 37232
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New Haven, Connecticut 6520
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630 W 168th St
New York, New York
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Newark, Delaware 19713
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Newark, Delaware 19713
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Palo Alto, California 94304
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Pembroke Pines, Florida 33028
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Pittsburgh, Pennsylvania 15213
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320 E North Ave
Pittsburgh, Pennsylvania 15212
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Pleasant Hill, California 94523
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Richmond, Virginia 23249
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Roanoke, Virginia 24014
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Roslyn, New York 11576
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Royal Oak, Michigan 48073
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3350 La Jolla Village Dr
San Diego, California 92161
(858) 552-8585
VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
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York, Pennsylvania 17405
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