A Long-term Follow-up Study to Evaluate the Predictive Value of BMS747158 in Patients Suspected of Coronary Artery Disease (CAD) - Full Text View

Purpose

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).

Condition	Intervention
Coronary Artery Disease (CAD)	Drug: BMS747158

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:

Independent predictive value of BMS747158 PET MPI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Comparison of independent incremental PV of BMS747158 PET MPI to SPECT MPI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Comparison of independent incremental PV of BMS747158 PET MPI to that of single photon SPECT MPI in patients with known or suspected CAD
Incidence of soft and hard cardiac events post BMS747158 administration [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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

Enrollment:	0
Study Start Date:	March 2013
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Intervention Details:

BMS747158 is a novel PET MPI agent labeled with Fluorine-18.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085162

Locations

United States, California
Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
Los Angeles, California, United States, 90048

Sponsors and Collaborators

Lantheus Medical Imaging

More Information

Publications:

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. Review.

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. 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. Review. 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. No abstract available.

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. Review. No abstract available.

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.

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; for the 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-e181. Epub 2008 Dec 15. No abstract available.

Responsible Party:	Lantheus Medical Imaging
ClinicalTrials.gov Identifier:	NCT01085162 History of Changes
Other Study ID Numbers:	BMS747158-501
Study First Received:	March 10, 2010
Last Updated:	April 2, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:

Coronary Artery Disease
PET imaging
SPECT imaging

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013