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

NCT01085162 | Withdrawn DMC

• 1 other identifier: BMS747158-501
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Artery Disease (CAD)

Keywords

Coronary Artery Disease; PET imaging; SPECT imaging

Outcome Measures

Primary Outcomes (1)

• Independent predictive value of BMS747158 PET MPI

  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.

  2 years

Secondary Outcomes (2)

• Comparison of independent incremental PV of BMS747158 PET MPI to SPECT MPI

  2 years

• Incidence of soft and hard cardiac events post BMS747158 administration

  2 years

Interventions

BMS747158 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (1)

Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center

Los Angeles, California, 90048, United States

Location

Related Publications (7)

• 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.

  PMID: 15724135 BACKGROUND

• 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.

  PMID: 9463028 BACKGROUND

• 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.

  PMID: 17372188 BACKGROUND

• 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.

  PMID: 18022101 BACKGROUND

• 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.

  PMID: 10736294 BACKGROUND

• 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.

  PMID: 14569247 BACKGROUND

• 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.

  PMID: 19075105 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

BMS 747158-02

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

US (1)