An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:June 8, 2018
End Date:August 2020
Contact:Aleksandar Sarac
Email:aleksandar.sarac@ge.com
Phone:+44 (0) 1494 546 138

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A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz
(18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.


Inclusion Criteria:

- The subject is a man or woman ≥18 years of age.

- The subject has read, signed, and dated an informed consent form (ICF) prior to any
study procedures being performed.

- At the time of enrolment, the subject has been scheduled via written documentation to
undergo an ICA for the assessment of CAD.

- The subject has undergone a clinically indicated SPECT OR the patient is willing to
undergo SPECT MPI for the purposes of the clinical study.

- The subject is male or is a nonpregnant, nonlactating female who is either surgically
sterile or is post-menopausal.

- The subject is able and willing to comply with all study procedures as described in
the protocol.

Exclusion Criteria:

- Patients who are pregnant, may possibly be pregnant, or wish (including their
partners) to become pregnant during the study period, or are lactating.

- Patients who are unable to undergo all of the imaging procedures.

- Patients who have an established diagnosis of CAD as confirmed by any of the
following:

1. Previous myocardial infarction (MI);

2. Previous cardiac catheter angiography showing ≥50% stenosis;

3. Previous coronary revascularisation, such as percutaneous coronary intervention
(PCI), thrombolysis or coronary artery bypass graft (CABG) placement.

- Patients incapable of undergoing either exercise or pharmacological cardiac stress
testing.

- Patients who have a current illness or pathology that, in the opinion of the
investigator, would pose a significant safety risk for the patient during cardiac
stress testing.

- Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection
fraction (LVEF) <50%).

- Patients scheduled for or planning to undergo any cardiac interventional procedures
between enrolment and ICA.

- Patients undergoing evaluation for heart transplantation or with history of heart
transplantation.

- Patients enrolled in another clinical study within the 30 days prior to being enrolled
in this study or scheduled to participate in another clinical study during the 7-day
follow-up period of this study.
We found this trial at
23
sites
Wyomissing, Pennsylvania 19610
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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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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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Birmingham, AL
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Des Moines, Iowa 50314
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Katy, TX
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Kingsport, Tennessee 37660
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Knoxville, Tennessee 37920
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Los Angeles, California 90033
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Los Angeles, California 90073
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Morgantown, West Virginia
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Orleans, Louisiana 70121
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Newark, Delaware 19713
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Roanoke, Virginia 24014
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915 North Grand Boulevard
Saint Louis, Missouri 63106
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Tomball, TX
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