Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00627783
• Other study ID #: 2000.217
• Status: Terminated
• Phase: N/A
• First received: February 22, 2008
• Last updated: February 29, 2008
• Start date: December 2000
• Est. completion date: July 2005

Study information

• Verified date: February 2008
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 642
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• a bicycle exercise test

Locations

Country	Name	City	State
France	Hopital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Unstable angina requiring hospitalization Coronary events Coronary revascularization