Type 2 Diabetes Mellitus
Conditions
Keywords
silent ischemia, type 2 diabetes mellitus, screening, cardiac outcome, Prevalence silent myocardial ischemia, Cardiac outcome in screened and not-screened subjects
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Astellas Pharma US, Inc.
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%. | At study entry |
| 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 |
| Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort | 5 years |
Countries
United States
Outcome results
None listed