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

Brief Summary

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)”

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 Type: Observational
  • Study Design: Time Perspective: Prospective
  • Study Primary Completion Date: March 2015

Interventions Used in this Clinical Trial

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Independent predictive value of BMS747158 PET MPI
    • Time Frame: 2 years
      Safety Issue?: No

Secondary Measures

  • Comparison of independent incremental PV of BMS747158 PET MPI to SPECT MPI
    • Time Frame: 2 years
      Safety Issue?: No
  • Incidence of soft and hard cardiac events post BMS747158 administration
    • Time Frame: 2 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Lantheus Medical Imaging
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

Source

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01085162