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

Sponsor

Lantheus Medical Imaging (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01085162

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease (CAD)	Drug: BMS747158

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Time Perspective:

Prospective

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)

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Mar 1, 2015

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.