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

This study has been terminated.
(Poor recruiting status)
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00627783
First received: February 22, 2008
Last updated: February 29, 2008
Last verified: February 2008

February 22, 2008
February 29, 2008
December 2000
July 2005   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00627783 on ClinicalTrials.gov Archive Site
Unstable angina requiring hospitalization Coronary events Coronary revascularization
Same as current
Not Provided
Not Provided
 
Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Type 2 Diabetes
Other: a bicycle exercise test
  • 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.
    Intervention: Other: a bicycle exercise test
  • No Intervention: Control
    Patients are treated according current guidelines but are not referred to a cardiologist
Lièvre MM, Moulin P, Thivolet C, Rodier M, Rigalleau V, Penfornis A, Pradignac A, Ovize M; DYNAMIT investigators. Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening. Trials. 2011 Jan 26;12:23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
642
July 2005
July 2005   (final data collection date for primary outcome measure)

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
Both
55 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00627783
2000.217
No
PLATTNER, MD, HOSPICES CIVILS DE LYON
Hospices Civils de Lyon
Not Provided
Not Provided
Hospices Civils de Lyon
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP