Clinical trial NCT01085162: A Long-term Follow-up Study to Evaluate the Predictive Value of BMS747158 in Patients Suspected of Coronary Artery Disease (CAD)
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease (CAD)
Keywords: Coronary Artery Disease
PET imaging
SPECT imaging
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2010-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from prior BMS747158 clinical studies. They will have known or suspected CAD and have received at least 1 dose of BMS747158.

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).


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.

Primary outcomes:
measure: Independent predictive value of BMS747158 PET MPI
timeFrame: 2 years
Secondary outcomes:
measure: Comparison of independent incremental PV of BMS747158 PET MPI to SPECT MPI
timeFrame: 2 years
measure: Incidence of soft and hard cardiac events post BMS747158 administration
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
state: California
Study officials:
References:
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