Detection of Ischemia in Asymptomatic Diabetics

Type 2 Diabetes Mellitus Clinical Trial

— DIAD  

Official title:

Detection of Ischemia in Asymptomatic Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769275
• Other study ID #: DIAD
• Secondary ID: HIC #11312
• Status: Completed
• Phase: N/A
• First received: October 8, 2008
• Last updated: October 8, 2008
• Start date: August 2000
• Est. completion date: January 2008

Study information

• Verified date: October 2008
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1123
• Est. completion date: January 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Ischemia
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Astellas Pharma US, Inc., Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (2)

Wackers FJ, Chyun DA, Young LH, Heller GV, Iskandrian AE, Davey JA, Barrett EJ, Taillefer R, Wittlin SD, Filipchuk N, Ratner RE, Inzucchi SE; Detection of Ischemia in Asymptomatic Diabetics (DIAD) Investigators. Resolution of asymptomatic myocardial ischemia in patients with type 2 diabetes in the Detection of Ischemia in Asymptomatic Diabetics (DIAD) study. Diabetes Care. 2007 Nov;30(11):2892-8. Epub 2007 Aug 6. — View Citation

Wackers FJ, Young LH, Inzucchi SE, Chyun DA, Davey JA, Barrett EJ, Taillefer R, Wittlin SD, Heller GV, Filipchuk N, Engel S, Ratner RE, Iskandrian AE; Detection of Ischemia in Asymptomatic Diabetics Investigators. Detection of silent myocardial ischemia in asymptomatic diabetic subjects: the DIAD study. Diabetes Care. 2004 Aug;27(8):1954-61. Erratum in: Diabetes Care. 2005 Feb;28(2):504. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%.		At study entry	No
Primary	At repeat stress imaging three years after recruitment 79% of subjects showed resolution of ischemia, whereas only 10% developed new ischemia.		3 years after start	No
Primary	Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort		5 years	No