Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes (DYNAMIT)
DYNAMIT is a prospective, randomized, multicenter, open strategy trial run in 45 French hospitals. Diabetic patients with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors are randomized to screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N=316), or follow-up without screening (N=315). All have access to cardiovascular prevention according current guidelines. The main end point is time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Randomized Strategy Trial Comparing Detection of Silent Ischemia With no Detection of Silent Ischemia in Asymptomatic Patients With Type 2 Diabetes Mellitus. Effects on Cardiovascular Events.|
- Death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention, measured after a minimum follow-up of 2 years
- Unstable angina requiring hospitalization Coronary events Coronary revascularization
|Study Start Date:||December 2000|
|Estimated Study Completion Date:||July 2005|
|Estimated Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
Patients are referred to a cardiologist for a systematic detection of silent ischemia by a bicycle exercise test performed according to the French Society of Cardiology protocol after washout of cardiovascular medications likely to interfere with the test. Dipyridamole Single Photon Emission Computed Tomography (SPECT) is used in patients unable to perform the exercise test, with a sub-maximal negative exercise test result or with electrocardiographic abnormalities impairing the interpretation of the exercise test. Subsequent investigations (such as coronary angiography) and treatments (such as revascularization procedures) are left at the cardiologist's decision.
|Other: a bicycle exercise test|
No Intervention: Control
Patients are treated according current guidelines but are not referred to a cardiologist