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.”

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 Type: Interventional

Study Design: Diagnostic, Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: July 2005

Intervention(s) in this Clinical Trial

• Other: a bicycle exercise test

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Intervention
  • 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.
• No Intervention: Control
  • Patients are treated according current guidelines but are not referred to a cardiologist

Primary Measures

• 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 Measures

• Unstable angina requiring hospitalization Coronary events Coronary revascularization

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospices Civils de Lyon

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00627783

Study ID Number: 2000.217

ClinicalTrials.gov Identifier: NCT00627783

Health Authority: France: Direction Générale de la Santé