Text Size

Detection of Ischemia in Asymptomatic Diabetics (DIAD)

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Astellas Pharma US, Inc.
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00769275
First received: October 8, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

October 8, 2008
October 8, 2008
August 2000
September 2007   (final data collection date for primary outcome measure)
  • Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%. [ Time Frame: At study entry ] [ Designated as safety issue: No ]
  • At repeat stress imaging three years after recruitment 79% of subjects showed resolution of ischemia, whereas only 10% developed new ischemia. [ Time Frame: 3 years after start ] [ Designated as safety issue: No ]
  • Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Detection of Ischemia in Asymptomatic Diabetics
Detection of Ischemia in Asymptomatic Diabetics

Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction.

The aims are:

  1. To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.
  2. To identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate.
  3. To assess progression of (silent) myocardial ischemia after 3 years.
  4. To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood
Non-Probability Sample

Asymptomatic patients with type 2 diabetes mellitus
Type 2 Diabetes Mellitus
Not Provided
  • 1
    Screening at start study with Adenosine vasodilator stress Tc-99m Sestamibi SPECT imaging
  • 2
    No screening

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1123
January 2008
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 50-75 years
  • Type 2 diabetes mellitus

Exclusion Criteria:

  • Angina or anginal equivalent
  • Abnormal rest ECG (Q or ST depression)
  • Known CAD
  • Stress testing within the last 3 years
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00769275
DIAD, HIC #11312
Yes
Frans J Th Wackers, MD, PhD, Yale University School of Medicine
Yale University
  • Bristol-Myers Squibb
  • Astellas Pharma US, Inc.
Study Chair: Frans J Wackers, MD Yale University
Yale University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP