Diabetes Mellitus Clinical Trial
Official title:
Study Comparing Coronary Computed Tomography Angiography and SPECT to Detect Subclinical Coronary Atherosclerosis in Asymptomatic Diabetes
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.
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).
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Observational Model: Cohort, Time Perspective: Prospective
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