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|
|Actual Primary Completion Date :||September 2007|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|