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 |
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).
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).
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
74
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
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1 Boston Medical Center Place
Boston, Massachusetts 02118
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Clearwater, Florida 33756
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Knoxville, Tennessee 37917
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UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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VA San Diego Healthcare System The VA San Diego Healthcare System (VASDHS) provides high quality...
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