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

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ClinicalTrials.gov Identifier: NCT01085162
Recruitment Status : Withdrawn
First Posted : March 11, 2010
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging

Tracking Information
First Submitted Date March 10, 2010
First Posted Date March 11, 2010
Last Update Posted Date April 4, 2013
Study Start Date March 2013
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2010)
Independent predictive value of BMS747158 PET MPI [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01085162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 10, 2010)
  • Comparison of independent incremental PV of BMS747158 PET MPI to SPECT MPI [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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).
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Coronary Artery Disease (CAD)
Intervention Drug: BMS747158
BMS747158 is a novel PET MPI agent labeled with Fluorine-18.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 2, 2013)
0
Original Estimated Enrollment
 (submitted: March 10, 2010)
1000
Estimated Study Completion Date March 2015
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01085162
Other Study ID Numbers BMS747158-501
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lantheus Medical Imaging
Study Sponsor Lantheus Medical Imaging
Collaborators Not Provided
Investigators Not Provided
PRS Account Lantheus Medical Imaging
Verification Date April 2013