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Detection of Ischemia in Asymptomatic Diabetics (DIAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00769275
First Posted: October 9, 2008
Last Update Posted: October 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bristol-Myers Squibb
Astellas Pharma US, Inc.
Information provided by:
Yale University
  Purpose

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.

Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Ischemia in Asymptomatic Diabetics

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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
blood

Enrollment: 1123
Study Start Date: August 2000
Study Completion Date: January 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Screening at start study with Adenosine vasodilator stress Tc-99m Sestamibi SPECT imaging
2
No screening

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asymptomatic patients with type 2 diabetes mellitus
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Bristol-Myers Squibb
Astellas Pharma US, Inc.
Investigators
Study Chair: Frans J Wackers, MD Yale University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frans J Th Wackers, MD, PhD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00769275     History of Changes
Other Study ID Numbers: DIAD
HIC #11312
First Submitted: October 8, 2008
First Posted: October 9, 2008
Last Update Posted: October 9, 2008
Last Verified: October 2008

Keywords provided by Yale University:
silent ischemia
type 2 diabetes mellitus
screening
cardiac outcome
Prevalence silent myocardial ischemia
Cardiac outcome in screened and not-screened subjects

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Ischemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes