Detection of Ischemia in Asymptomatic Diabetics (DIAD)

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Astellas Pharma US, Inc.
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00769275
First received: October 8, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: October 8, 2008
Last Updated: October 8, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014