Detection of Ischemia in Asymptomatic Diabetics - Full Text View

Sponsor:	Yale University
Collaborators:	Bristol-Myers Squibb Astellas Pharma US, Inc.
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00769275

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:

To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.
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.
To assess progression of (silent) myocardial ischemia after 3 years.
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:	Cohort, Prospective
Official Title:	Detection of Ischemia in Asymptomatic Diabetics

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Heart Attack

U.S. FDA Resources

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

Biospecimen Description:

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:

Wackers FJ, Young LH, Inzucchi SE, Chyun DA, Davey JA, Barrett EJ, Taillefer R, Wittlin SD, Heller GV, Filipchuk N, Engel S, Ratner RE, Iskandrian AE; Detection of Ischemia in Asymptomatic Diabetics Investigators. Detection of silent myocardial ischemia in asymptomatic diabetic subjects: the DIAD study. Diabetes Care. 2004 Aug;27(8):1954-61. Erratum in: Diabetes Care. 2005 Feb;28(2):504.

Wackers FJ, Chyun DA, Young LH, Heller GV, Iskandrian AE, Davey JA, Barrett EJ, Taillefer R, Wittlin SD, Filipchuk N, Ratner RE, Inzucchi SE; Detection of Ischemia in Asymptomatic Diabetics (DIAD) Investigators. Resolution of asymptomatic myocardial ischemia in patients with type 2 diabetes in the Detection of Ischemia in Asymptomatic Diabetics (DIAD) study. Diabetes Care. 2007 Nov;30(11):2892-8. Epub 2007 Aug 6.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Young LH, Wackers FJ, Chyun DA, Davey JA, Barrett EJ, Taillefer R, Heller GV, Iskandrian AE, Wittlin SD, Filipchuk N, Ratner RE, Inzucchi SE; DIAD Investigators. Cardiac outcomes after screening for asymptomatic coronary artery disease in patients with type 2 diabetes: the DIAD study: a randomized controlled trial. JAMA. 2009 Apr 15;301(15):1547-55.

Responsible Party:	Yale University School of Medicine ( Frans J Th Wackers, MD, PhD )
Study ID Numbers:	DIAD, HIC #11312
Study First Received:	October 8, 2008
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00769275 History of Changes
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:

Pathologic Processes
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Ischemia
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2009