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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.
ClinicalTrials.gov Identifier: NCT00162344
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 15, 2011
Information provided by:
Lantheus Medical Imaging

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Technetium Tc99m Sestamibi Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: AceP-D: Non-invasive Assessment of Atypical Chest Pain in Patients With Diabetes
Study Start Date : December 2003
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain.

Secondary Outcome Measures :
  1. 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.
  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162344

United States, California
Local Institution
Mission Viejo, California, United States
Local Institution
Rancho Santa Fe, California, United States
Local Institution
San Diego, California, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, Indiana
Local Institution
Indianapolis, Indiana, United States
United States, Michigan
Local Institution
Detroit, Michigan, United States
United States, Minnesota
Local Institution
Minneapolis, Minnesota, United States
United States, New York
Local Institution
Albany, New York, United States
Local Institution
Roslyn, New York, United States
United States, Ohio
Local Institution
Columbus, Ohio, United States
United States, Texas
Local Institution
Houston, Texas, United States
Canada, Quebec
Local Institution
Montreal, Quebec, Canada
Sponsors and Collaborators
Lantheus Medical Imaging
Principal Investigator: Martin Rosenberg, MD Bristol-Myers Squibb

Responsible Party: Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162344     History of Changes
Other Study ID Numbers: CARDIOLITE-404
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Technetium Tc 99m Sestamibi
Molecular Mechanisms of Pharmacological Action