Detection of Ischemia in Asymptomatic Diabetics (DIAD)

Yale University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00769275

DIAD

HIC #11312

Details and patient eligibility

About

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.

Enrollment: 1,123 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,123 participants in 2 patient groups

1

Description:

Screening at start study with Adenosine vasodilator stress Tc-99m Sestamibi SPECT imaging

2

Description:

No screening