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

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)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01085162

Enrollment

Registered

2010-03-11

Start date

2013-03-31

Completion date

2015-03-31

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease (CAD)

Keywords

Coronary Artery Disease, PET imaging, SPECT 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).

Interventions

DRUGBMS747158

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026