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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014