Detection of Ischemia in Asymptomatic Diabetics
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT00769275
- Lead Sponsor
- Yale University
- 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:
1. To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.
2. 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.
3. To assess progression of (silent) myocardial ischemia after 3 years.
4. To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1123
- Age 50-75 years
- Type 2 diabetes mellitus
- Angina or anginal equivalent
- Abnormal rest ECG (Q or ST depression)
- Known CAD
- Stress testing within the last 3 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%. At study entry Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort 5 years At repeat stress imaging three years after recruitment 79% of subjects showed resolution of ischemia, whereas only 10% developed new ischemia. 3 years after start
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Yale University School of Medicine🇺🇸New Haven, Connecticut, United States