Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: a bicycle exercise test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 55 to 75 years old had type-2 diabetes and at least two of the following cardiovascular risk factors: urinary albumin excretion > 30 mg/L or > 30 mg/24 hours, treated or untreated hypertension, treated or untreated lipid abnormality, peripheral arterial disease, history of transient ischemic accident, tobacco consumption familial history of premature cardiovascular disease. Exclusion Criteria: History of myocardial infarction, coronary artery disease, or stroke, Previous positive stress test or myocardial perfusion imaging, Negative stress test or myocardial perfusion imaging within the last three years

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br> <br> |
| No Intervention: Control<br>Patients are treated according current guidelines but are not referred to a cardiologist | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unstable angina requiring hospitalization Coronary events Coronary revascularization |  |  |