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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Coronary Artery Disease (CAD)
Drug: BMS747158

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BMS747158
    BMS747158 is a novel PET MPI agent labeled with Fluorine-18.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085162

Locations
United States, California
Cedars-Sinai Medical Center, S. Mark Taper Foundation Imaging Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Lantheus Medical Imaging
  More Information

Publications:

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT01085162     History of Changes
Other Study ID Numbers: BMS747158-501
Study First Received: March 10, 2010
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
Coronary Artery Disease
PET imaging
SPECT imaging

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014