Detection of Ischemia in Asymptomatic Diabetics (DIAD)
|ClinicalTrials.gov Identifier: NCT00769275|
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : October 9, 2008
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:
- To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.
- 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.
- To assess progression of (silent) myocardial ischemia after 3 years.
- To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.
|Condition or disease|
|Type 2 Diabetes Mellitus|
|Study Type :||Observational|
|Actual Enrollment :||1123 participants|
|Official Title:||Detection of Ischemia in Asymptomatic Diabetics|
|Study Start Date :||August 2000|
|Primary Completion Date :||September 2007|
|Study Completion Date :||January 2008|
Screening at start study with Adenosine vasodilator stress Tc-99m Sestamibi SPECT imaging
- Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%. [ Time Frame: At study entry ]
- 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 ]
- Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort [ Time Frame: 5 years ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769275
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520|
|Study Chair:||Frans J Wackers, MD||Yale University|