Coronary Computed Tomography Angiography and SPECT in Asymptomatic Diabetes

This study has been completed.

Sponsor:

Information provided by:

Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT00431717

First received: February 5, 2007

Last updated: August 22, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 5, 2007

Last Updated Date

August 22, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00431717 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Coronary Computed Tomography Angiography and SPECT in Asymptomatic Diabetes

Official Title ^ICMJE

Study Comparing Coronary Computed Tomography Angiography and SPECT to Detect Subclinical Coronary Atherosclerosis in Asymptomatic Diabetes

Brief Summary

The purpose of this study is to compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.

Detailed Description

Coronary artery disease (CAD) is the leading cause of death in patients with diabetes. Patients with diabetes are known to have silent myocardial ischemia more frequently than those without diabetes. Furthermore, CAD in patients with diabetes frequently manifested in advance stage, and morbidity and mortality are higher than those without diabetes. Early screening and treatment of CAD in asymptomatic patients with diabetes might reduce high morbidity and mortality.

Myocardial perfusion single photon emission computerized tomography (SPECT) is known as a gold standard method in detecting silent myocardial ischemia in asymptomatic patients with diabetes. Despite of the power of detecting myocardial ischemia functionally, there are limitations of SPECT in diagnosing subclinical coronary atherosclerosis anatomically. In recent advance in technology, coronary CT angiography (CTA) could detect subclinical coronary atherosclerosis. However, there is a paucity of information comparing the diagnostic power between SPECT and CTA.

Therefore in our study, we compare the difference of diagnostic efficiency between coronary CT angiography and myocardial perfusion single photon emission computerized tomography in asymptomatic patients with type 2 diabetes mellitus.

In this study, we will recruit asymptomatic patients with diabetes. At the time of enrollment, all patients will undergo two imaging studies (SPECT and CTA) within a few days apart. When patients had positive result in either study, they will undergo coronary angiography for confirmation. We will evaluate the results of two studies comparing with coronary angiography. When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed. Investigators will evaluate the status of diabetic complication (retinopathy/nephropathy/cardiac autonomic neuropathy).

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Asymptomtaic type 2 diabetes mellitus with multiple risk factors

Condition ^ICMJE

Coronary Atherosclerosis
Diabetes Mellitus

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

116

Completion Date

September 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 diabetes mellitus
Age 50 ~ 75 years
Duration of diabetes: more than 5 years
More than two of the following risk factors in addition to diabetes:

1)dyslipidemia, 2)hypertension, 3)smoking, 4)family history of premature coronary artery disease

Exclusion Criteria:

Angina pectoris or anginal equivalent symptoms
Insulin pump user or history of ketoacidosis
History of myocardial infarction, heart failure, or coronary revascularization
Electrocardiographic evidence of Q-wave myocardial infarction, ischemic ST- segment or T-wave changes, or complete left bundle branch block
Uncontrolled arrythmia
Hypersensitivity to contrast dye
Renal failure

Gender

Both

Ages

50 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00431717

Other Study ID Numbers ^ICMJE

B-0609/037-019

Has Data Monitoring Committee

Yes

Responsible Party

Hyuk-Jae Chang MD, PhD, Seoul National University Bundang Hospital

Study Sponsor ^ICMJE

Seoul National University Bundang Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Huk-Jae Chang, MD, PhD

Seoul National University Bundang Hospital

Information Provided By

Seoul National University Bundang Hospital

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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