Clinical trial NCT00769275: Detection of Ischemia in Asymptomatic Diabetics
Official title: Detection of Ischemia in Asymptomatic Diabetics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: silent ischemia
type 2 diabetes mellitus
screening
cardiac outcome
Prevalence silent myocardial ischemia
Cardiac outcome in screened and not-screened subjects
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Astellas Pharma US, Inc.
First posted: 2008-10-09
Enrollment: 1123
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asymptomatic patients with type 2 diabetes mellitus

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Prevalence of silent myocardial ischemia in subjects randomized to screening was 22%.
timeFrame: At study entry
measure: At repeat stress imaging three years after recruitment 79% of subjects showed resolution of ischemia, whereas only 10% developed new ischemia.
timeFrame: 3 years after start
measure: Overall cardiac event rate (cardiac death, myocardial infarction) was 3.0%, not different in screened and not screened cohort
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Frans J Wackers, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.