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临床试验/NCT03263728
NCT03263728已完成不适用

Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2017年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
Prevalence of myocardial ischaemia

研究概览

简要总结

The aim of this study is to determine the prevalence of myocardial ischaemia in asymptomatic high risk type 2 diabetic patients using stress cardiac MR and how many stress cardiac MR examinations are false positive.

详细描述

Asymptomatic coronary artery disease (CAD) is highly prevalent (ie. 17-59%) in type 2 diabetic patients. In addition, cardiovascular disease remains the most common cause of death in type 2 diabetics. Previous trials using coronary computed tomography angiograms (CCTA) or nuclear myocardial perfusion imaging (MPI) to screen for asymptomatic coronary artery disease requiring intervention have been unsuccessful at reducing cardiovascular and all cause mortality when compared to optimised medical therapy where cardiovascular risk factors are treated in order to reduce cardiovascular complications. Possible reasons for this include, the choice of imaging modality, the intervention chosen (eg. bare metal stents vs drug eluting stents), patient cohort (eg. all diabetics vs high risk diabetics). Stress cardiac magnetic resonance (CMR) is ideally suited to assess this group of high risk patients as there is no radiation exposure and it allows a more complete analysis of the heart including the assessment of myocardial viability, cardiac systolic and diastolic function. The significance of this envisioned randomised controlled trial is firstly to investigate if stress CMR screening will reduce major adverse cardiovascular events including death. Secondly, a study using stress CMR has never been performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Onset of type 2 diabetes at ≥30yrs old with no history of ketoacidosis
  • 60-80yrs old
  • Framingham Risk Score ≥20%

排除标准

  • Angina pectoris or chest discomfort
  • Stress test or coronary angiography within 2 years
  • Previous myocardial infarction (MI)
  • Previous coronary artery stenting or coronary artery bypass grafting
  • Any clinical indication or contraindication for stress testing
  • Any contraindication to stress CMR (eg. non-MRI compatible devices)
  • Contraindication to gadolinium based contrast agent (eg. Renal impairment with an estimated glomerular filtration rate (GFR) <30ml/min/1.73m2)
  • Life expectancy <2 years due to cancer or liver disease
  • Contraindication to dual antiplatelet therapy
  • Planned need for concomitant cardiac surgery
  • Refusal or inability to sign an informed consent.
  • Potential for non-compliance towards the requirements in the trial protocol
  • Unable to cover the costs of percutaneous coronary intervention (PCI) whether through government subsidies, etc

研究组 & 干预措施

Stress Cardiac MR

Experimental

干预措施: Cardiac Magnetic Resonance (Diagnostic Test)

结局指标

主要结局

Prevalence of myocardial ischaemia

时间窗: 1 year

次要结局

  • Prevalence of myocardial infarction(1 year)
  • Clinical predictors of silent ischaemia(1 year)
  • Major adverse cardiovascular events(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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