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

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
|
- 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
- Unstable angina requiring hospitalization Coronary events Coronary revascularization

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

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
France | |
Hopital Louis Pradel | |
Bron, France, 69500 |
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 |