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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Terminated

CT.gov ID

NCT00627783

Collaborator

(none)

642

Enrollment

Location

Arms

Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Dec 1, 2000

Primary Completion Date :

Jul 1, 2005

Study Completion Date :

Jul 1, 2005

Arms and Interventions

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

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hopital Louis Pradel	Bron		France	69500

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00627783

Other Study ID Numbers:

2000.217

First Posted:

Mar 3, 2008

Last Update Posted:

Mar 3, 2008

Last Verified:

Feb 1, 2008

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Ischemia

Study Results

No Results Posted as of Mar 3, 2008