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)

Lantheus Medical Imaging1 site in 1 countryMarch 2013

ConditionsCoronary Artery Disease (CAD)

DrugsBMS747158

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease (CAD)
Sponsor: Lantheus Medical Imaging
Locations: 1
Primary Endpoint: Independent predictive value of BMS747158 PET MPI
Status: Withdrawn
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

March 2015

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Lantheus Medical Imaging

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Independent predictive value of BMS747158 PET MPI

Time Frame: 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 Outcomes

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)