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

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
a bicycle exercise test
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital Louis Pradel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Patients are treated according current guidelines but are not referred to a cardiologist

Outcomes

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

Full Information

First Posted
February 22, 2008
Last Updated
February 29, 2008
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT00627783
Brief Title
Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes
Acronym
DYNAMIT
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 Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Terminated
Why Stopped
Poor recruiting status
Study Start Date
December 2000 (undefined)
Primary Completion Date
July 2005 (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
642 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients are treated according current guidelines but are not referred to a cardiologist
Intervention Type
Other
Intervention Name(s)
a bicycle exercise test
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Unstable angina requiring hospitalization Coronary events Coronary revascularization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hopital Louis Pradel
City
Bron
ZIP/Postal Code
69500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21269454
Citation
Lievre 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.
Results Reference
derived

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Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes

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