Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes

Not Applicable

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Other: a bicycle exercise test

• Registration Number: NCT00627783
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2008-02
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-29
• Last Update Submitted: 2008-02-29
• Study First Posted: 2008-03-03
• Last Update Posted: 2008-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 642

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	a bicycle exercise test	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Unstable angina requiring hospitalization Coronary events Coronary revascularization

Trial Locations

Locations (1)

Hopital Louis Pradel; 🇫🇷 Bron, France