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	Intervention	Phase
Diabetes	Drug: Technetium Tc99m Sestamibi	Phase IV

Further Study Details: 

Primary Outcomes: Examine the prevalence of ischemic heart disease in population of patients with diabetes mellitus and atypical chest pain.
Secondary Outcomes: 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.
Expected Total Enrollment:  500

Ages Eligible for Study:  18 Years   -   76 Years,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00162344

BMS Call Center      1 866 892 1BMS  Ext. 200 

California
      Local Institution, Rancho Santa Fe,  California,  United States; Recruiting
      Local Institution, Mission Viejo,  California,  United States; Recruiting
Illinois
      Local Institution, Winfield,  Illinois,  United States; Recruiting
Indiana
      Local Institution, Indianapolis,  Indiana,  United States; Recruiting
Minnesota
      Local Institution, St. Paul,  Minnesota,  United States; Recruiting
New York
      Local Institution, Albany,  New York,  United States; Recruiting
Canada, Quebec
      Local Institution, Montreal,  Quebec,  Canada; Recruiting

Study chairs or principal investigators

Martin Rosenberg, MD,  Principal Investigator,  Bristol Myers Squibb Medical Imaging   

Study ID Numbers:  CARDIOLITE-404
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162344
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13