A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.

This study has been completed.
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162344
First received: September 9, 2005
Last updated: April 14, 2011
Last verified: April 2011

September 9, 2005
April 14, 2011
December 2003
December 2005   (final data collection date for primary outcome measure)
Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain.
Same as current
Complete list of historical versions of study NCT00162344 on ClinicalTrials.gov Archive Site
  • Determine the accuracy of myocardial perfusion imaging (MPI) and exercise tolerance testing (ETT) for the detection of coronary artery disease (CAD) in a subset of patients undergoing clinically indicated coronary angiography.
  • Determine the relative value of ETT, Duke Treadmill Score (DTS), MPI, ejection fraction (EF), clinical risk factors, and C-Reactive Protein (CRP) values for identifying patients at risk for cardiac events.
Same as current
Not Provided
Not Provided
 
A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.
AceP-D: Non-invasive Assessment of Atypical Chest Pain in Patients With Diabetes

The study is designed to see if stress heart imaging can be used as a screening exam in patients with diabetes and risk factors of developing of coronary artery disease and experiencing future cardiac events.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes
Drug: Technetium Tc99m Sestamibi
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
December 2005
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of diabetes for at least 5 years, with a least 2 risk factors (i.e. hypertension, elevated cholesterol levels, history of or current smoker, obese, family history of heart disease) & atypical chest pain.

Exclusion Criteria:

  • Typical chest pain being treated with medication, unable to exercise, previous confirmed heart disease
Both
18 Years to 76 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00162344
CARDIOLITE-404
Not Provided
Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
Lantheus Medical Imaging
Not Provided
Principal Investigator: Martin Rosenberg, MD Bristol-Myers Squibb
Lantheus Medical Imaging
April 2011

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