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Completed

NCT Number: NCT00769275

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%.

    Time frame: At study entry

  2. 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

  3. Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort

    Time frame: 5 years

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Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Astellas Pharma US, Inc.
  • Bristol-Myers Squibb

Registry information

Acronym: DIAD

Important dates

Study start
2000
Primary completion
2007
Study completion
2008
First posted
Oct 9, 2008
Registry last updated
Oct 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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