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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00162344
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 15, 2011
Information provided by:
Lantheus Medical Imaging

September 9, 2005
September 13, 2005
April 15, 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 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
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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.
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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Drug: Technetium Tc99m Sestamibi
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years to 76 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
Lantheus Medical Imaging
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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