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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT01085162
First received: March 10, 2010
Last updated: April 2, 2013
Last verified: April 2013

March 10, 2010
April 2, 2013
March 2013
March 2015   (final data collection date for primary outcome measure)
Independent predictive value of BMS747158 PET MPI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01085162 on ClinicalTrials.gov Archive Site
  • Comparison of independent incremental PV of BMS747158 PET MPI to SPECT MPI [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
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)

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).

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Coronary Artery Disease (CAD)
Drug: BMS747158
BMS747158 is a novel PET MPI agent labeled with Fluorine-18.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01085162
BMS747158-501
Yes
Lantheus Medical Imaging
Lantheus Medical Imaging
Not Provided
Not Provided
Lantheus Medical Imaging
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP