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Detection of Ischemia in Asymptomatic Diabetics

NCT ID: NCT00769275

Last Updated: 2008-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-08-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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silent ischemia type 2 diabetes mellitus screening cardiac outcome Prevalence silent myocardial ischemia Cardiac outcome in screened and not-screened subjects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Screening at start study with Adenosine vasodilator stress Tc-99m Sestamibi SPECT imaging

No interventions assigned to this group

2

No screening

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Yale University School of Medicine

Principal Investigators

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Frans J Wackers, MD

Role: STUDY_CHAIR

Yale University

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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. doi: 10.2337/diacare.27.8.1954.

Reference Type BACKGROUND
PMID: 15277423 (View on PubMed)

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. doi: 10.2337/dc07-1250. Epub 2007 Aug 6.

Reference Type BACKGROUND
PMID: 17682123 (View on PubMed)

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. doi: 10.1001/jama.2009.476.

Reference Type DERIVED
PMID: 19366774 (View on PubMed)

Other Identifiers

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HIC #11312

Identifier Type: -

Identifier Source: secondary_id

DIAD

Identifier Type: -

Identifier Source: org_study_id