跳至主要内容
临床试验/NCT05801432
NCT05801432
招募中
不适用

Diabetes Follow-up Study for REduction of cardiovAscular outcoMes: a Coronary Computed Tomographic Angiography Cohort Study

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 511 人2021年8月24日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Diabetes Mellitus
发起方
Asan Medical Center
入组人数
511
试验地点
1
主要终点
The change in coronary atherosclerosis detected by initial and follow-up CCTA
状态
招募中
最后更新
上个月

概览

简要总结

The purpose of this study is to evaluate the natural history of coronary atherosclerosis development and progression over time by CCTA and to identify risk factors attributable to the development of coronary atherosclerosis in a Korean DM population.

详细描述

Patients with diabetes mellitus, who underwent initial CCTA (coronary computed tomographic angiography) at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012, will be evaluated for inclusion in the study. All DREAM-CCTA study patients will undergo follow-up CCTA based on order from their primary physician. CCTA and demographic data, medical history, cardiovascular risk factors, and laboratory data was collected in case report forms at the time of the initial CCTA and at the time of follow-up CCTA.

注册库
clinicaltrials.gov
开始日期
2021年8月24日
结束日期
2026年12月31日
最后更新
上个月
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Seung-Whan Lee, M.D., Ph.D.

Part of cardiology, Principal Investigator, associate professor

Asan Medical Center

入排标准

入选标准

  • Age 19 years or older
  • Asymptomatic patients with type 2 DM who had undergone initial CCTA evaluation at the Diabetes Center of the Asan Medical Center between February 2008 and June 2012
  • Willing and able to provide informed written consent

排除标准

  • Blood test results that the Creatinine level exceeds 1.5 mg/dL
  • A person with a history of anaphylaxis or allergic shock associated with a contrast medium
  • Pregnant women
  • Unable to undergo follow-up CCTA
  • Uninterpretable CCTA

结局指标

主要结局

The change in coronary atherosclerosis detected by initial and follow-up CCTA

时间窗: about 10 years after first CCTA

the natural history of coronary atherosclerotic plaque development and progression over time by CCTA

研究点 (1)

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