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临床试验/NCT00431717
NCT00431717已完成不适用

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

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
1

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究者

申办方类型
Other

研究点 (1)

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