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

Withdrawn

• Conditions: Coronary Artery Disease (CAD)

• Registration Number: NCT01085162
• Lead Sponsor: Lantheus Medical Imaging

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Study Start: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Independent predictive value of BMS747158 PET MPI	2 years	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

Name	Time	Method
Comparison of independent incremental PV of BMS747158 PET MPI to SPECT MPI	2 years	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	2 years	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

Trial Locations

Locations (1)

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