NCT00627783

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
642

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Dec 2000

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
Last Updated

March 3, 2008

Status Verified

February 1, 2008

Enrollment Period

4.6 years

First QC Date

February 22, 2008

Last Update Submit

February 29, 2008

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Unstable angina requiring hospitalization Coronary events Coronary revascularization

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

a bicycle exercise testOTHER
Intervention

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Louis Pradel

Bron, 69500, France

Location

Related Publications (1)

  • 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.

    PMID: 21269454DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2008

First Posted

March 3, 2008

Study Start

December 1, 2000

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

March 3, 2008

Record last verified: 2008-02

Locations

FR(1)