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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
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
 Other: a bicycle exercise test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome 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 Outcome Measures:
  • Unstable angina requiring hospitalization Coronary events Coronary revascularization

Enrollment: 642
Study Start Date: December 2000
Estimated Study Completion Date: July 2005
Estimated Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627783

Locations
France
Hopital Louis Pradel
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided by Hospices Civils de Lyon

Additional 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
Study First Received: February 22, 2008
Last Updated: February 29, 2008
Health Authority: France: Direction Générale de la Santé

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

ClinicalTrials.gov processed this record on May 21, 2013