Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes (DYNAMIT)

Civil Hospices of Lyon

Status: Terminated

Conditions: Type 2 Diabetes

Treatments: Other: a bicycle exercise test

Study type: Interventional

Funder types: Other

Identifiers

NCT00627783

2000.217

Details and patient eligibility

About

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.

Enrollment: 642 patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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642 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: a bicycle exercise test

Control

No Intervention group

Description:

Patients are treated according current guidelines but are not referred to a cardiologist