NCT00769275
Completed
Not Applicable
Detection of Ischemia in Asymptomatic Diabetics
ConditionsType 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Yale University
- Enrollment
- 1123
- Locations
- 1
- Primary Endpoint
- Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%.
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction.
The aims are:
- To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.
- To identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate.
- To assess progression of (silent) myocardial ischemia after 3 years.
- To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 50-75 years
- •Type 2 diabetes mellitus
Exclusion Criteria
- •Angina or anginal equivalent
- •Abnormal rest ECG (Q or ST depression)
- •Known CAD
- •Stress testing within the last 3 years
Outcomes
Primary Outcomes
Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%.
Time Frame: At study entry
Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort
Time Frame: 5 years
At repeat stress imaging three years after recruitment 79% of subjects showed resolution of ischemia, whereas only 10% developed new ischemia.
Time Frame: 3 years after start
Study Sites (1)
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