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: 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.

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

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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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. doi: 10.1186/1745-6215-12-23.


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

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Ischemia Glucose Metabolism Disorders	Metabolic Diseases Endocrine System Diseases Pathologic Processes

ClinicalTrials.gov processed this record on September 19, 2017

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