- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01085162
A Long-term Follow-up Study to Evaluate the Predictive Value of BMS747158 in Patients Suspected of Coronary Artery Disease (CAD)
April 2, 2013 updated by: Lantheus Medical Imaging
An Open-Label Prospective, Non-Randomized, International, Multi-center, Long-term Follow-up Study to Evaluate the Predictive Value of BMS747158 Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in Patients Suspected of Coronary Artery Disease (CAD)
This long-term study will follow patients with known or suspected of having coronary artery disease (CAD) and have participated in present and future BMS747158 clinical studies.
The purpose of this study is to evaluate the long-term predictive value associated with BMS747158 Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI).
Study Overview
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects will be recruited from prior BMS747158 clinical studies.
They will have known or suspected CAD and have received at least 1 dose of BMS747158.
Description
Inclusion Criteria:
- Have known or suspected CAD
- Have participated in a BMS747158 clinical study
- Have received at least 1 dose of BMS747158
- Provide signed informed consent for this study prior to any follow-up contact
- Be capable of communicating effectively with study personnel
Exclusion Criteria:
- If determined by the Investigator that participation in the study is not in the best interest of the patient or for any sound medical, psychiatric, and/or social reason.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Independent predictive value of BMS747158 PET MPI
Time Frame: 2 years
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The primary outcome measure is the independent predictive value (PV) of rest and stress BMS747158 PET MPI in defining cardicac populations at high and low risk of developing cardiac events.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of independent incremental PV of BMS747158 PET MPI to SPECT MPI
Time Frame: 2 years
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Comparison of independent incremental PV of BMS747158 PET MPI to that of single photon SPECT MPI in patients with known or suspected CAD
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2 years
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Incidence of soft and hard cardiac events post BMS747158 administration
Time Frame: 2 years
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Incidence of soft and hard cardiac events post BMS747158 administration in patients with positive and negative BMS747158 PET MPI scans obtained in the qualifying study
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Beller GA. First annual Mario S. Verani, MD, Memorial lecture: clinical value of myocardial perfusion imaging in coronary artery disease. J Nucl Cardiol. 2003 Sep-Oct;10(5):529-42. doi: 10.1016/s1071-3581(03)00655-x.
- Beller GA, Zaret BL. Contributions of nuclear cardiology to diagnosis and prognosis of patients with coronary artery disease. Circulation. 2000 Mar 28;101(12):1465-78. doi: 10.1161/01.cir.101.12.1465. No abstract available.
- Glover DK, Gropler RJ. Journey to find the ideal PET flow tracer for clinical use: are we there yet? J Nucl Cardiol. 2007 Nov-Dec;14(6):765-8. doi: 10.1016/j.nuclcard.2007.09.019. No abstract available.
- Di Carli MF, Hachamovitch R. New technology for noninvasive evaluation of coronary artery disease. Circulation. 2007 Mar 20;115(11):1464-80. doi: 10.1161/CIRCULATIONAHA.106.629808. No abstract available.
- Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. No abstract available. Erratum In: Circulation. 2009 Jan 27;119(3):e182. Circulation. 2010 Jul 6;122(1):e11. Circulation. 2011 Oct 18;124(16):e424.
- Clark AN, Beller GA. The present role of nuclear cardiology in clinical practice. Q J Nucl Med Mol Imaging. 2005 Mar;49(1):43-58.
- Ritchie JL, Bateman TM, Bonow RO, Crawford MH, Gibbons RJ, Hall RJ, O'Rourke RA, Parisi AF, Verani MS. Guidelines for clinical use of cardiac radionuclide imaging: A report of the American College of Cardiology/American Heart Association Task Force on assessment of diagnostic and therapeutic cardiovascular procedures (Committee on Radionuclide Imaging)--developed in collaboration with the American Society of Nuclear Cardiology. J Nucl Cardiol. 1995 Mar-Apr;2(2 Pt 1):172-92. doi: 10.1016/s1071-3581(06)80030-9. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Anticipated)
March 1, 2015
Study Completion (Anticipated)
March 1, 2015
Study Registration Dates
First Submitted
March 10, 2010
First Submitted That Met QC Criteria
March 10, 2010
First Posted (Estimate)
March 11, 2010
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 2, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMS747158-501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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