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

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ClinicalTrials.gov Identifier: NCT00627783
Recruitment Status : Terminated (Poor recruiting status)
First Posted : March 3, 2008
Last Update Posted : March 3, 2008
Sponsor:
Information provided by:
Hospices Civils de Lyon

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: a bicycle exercise test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 642 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Study Start Date : December 2000
Primary Completion Date : July 2005
Study Completion Date : July 2005

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Arms and Interventions
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Arm Intervention/treatment
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.
 Other: a bicycle exercise test
No Intervention: Control
Patients are treated according current guidelines but are not referred to a cardiologist


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Unstable angina requiring hospitalization Coronary events Coronary revascularization

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627783


Locations
France
Hopital Louis Pradel
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: PLATTNER, MD, HOSPICES CIVILS DE LYON
ClinicalTrials.gov Identifier: NCT00627783     History of Changes
Other Study ID Numbers: 2000.217
First Posted: March 3, 2008    Key Record Dates
Last Update Posted: March 3, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Ischemia
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pathologic Processes