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

Lantheus Medical Imaging

Overview

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

Conditions

Coronary Artery Disease (CAD)

Interventions

BMS747158DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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

Comparison of independent incremental PV of BMS747158 PET MPI to that of single photon SPECT MPI in patients with known or suspected CAD

Time frame: 2 years

Incidence of soft and hard cardiac events post BMS747158 administration

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

Time frame: 2 years

Data from ClinicalTrials.gov

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