跳至主要内容
临床试验/NCT07068399
NCT07068399招募中不适用

Use of Shock Wave Therapy for Neo-Vascularisation in Non-critical Coronary Artery Disease: Validation by Quantitative Cardiac MRI Perfusion

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Myocardial perfusion

研究概览

简要总结

This is a randomised controlled trial aimed to demonstrate the effect of cardiac extracorporeal shock wave therapy (CSWT) on the angiogenesis effect of myocardium by determining myocardial perfusion and left ventricular function in patients with coronary artery disease (CAD) when measured by cardiac MRI before and after the treatment.

详细描述

In 2017 a systematic review of extracorporeal shock wave therapy (ESWT) in the treatment of coronary artery disease was undertaken by Berneikaite G. et al. to perform meta-analysis regarding anti-anginal efficacy of Cardiac ESWT (CSWT). The review identified 39 studies encompassing 1,189 patients with 1006 patients treated by CSWT. The meta-analysis found all selected studies demonstrated significant improvement in subjective measures of angina symptoms and/or quality of life, while the majority of studies also found improvement in left ventricular function and myocardial perfusion. For myocardial perfusion, SPECT was employed in 27 of 32 studies and PET in 2 of 4 studies. Cassar et al compared myocardial segments that were treated with CSWT and those segments that were not, finding after 4 months of follow-up that the progression of Ischaemic burden of untreated segments was significantly greater. As Cardiac MRI has not been employed to monitor myocardial perfusion in these studies, and with the increasing number of reports demonstrating the usefulness of MRI in characterising ischaemia, it seems opportune to utilise this non-radioactive technology to study the beneficial effect of CSWT in non-critical Coronary artery cases who have been found to have serially increasing coronary plaque burden. It has been shown that efficacious Statin usage can progressively regress coronary plaque volume, so augmenting collateral flow at stenotic coronary sites would buy time for Statin usage to complete this regression for definitive cure of CAD. With the availability of MRI methods to quantify myocardial perfusion accurately, the efficacy of CSWT for Neovascularization can thus be effectively documented as numerical data using Quantitative Cardiac MRI Perfusion, accompanied by Bull's eye views for ease of visual appreciation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients with symptoms of coronary artery disease
  • Patients without obstructive coronary artery disease
  • with LVEF not < 40%.

排除标准

  • Age < 18 years,
  • Pregnancy or lactation.
  • Contraindication to contrast enhanced stress Cardiac Magnetic Resonance (eg. Estimated GFR <30ml/min/1.73m2, severe allergy to gadolinium based contrast agent, contraindication to adenosine)
  • Life expectancy <24 months
  • Haemodynamically unstable
  • Participation in other clinical trial within 6 months of enrollment.
  • Recent myocardial infarction within 6 months.
  • Unable to consent to or perform components of the study.

结局指标

主要结局

Myocardial perfusion

时间窗: 6 months and 3 weeks

Quantitative magnetic resonance imaging with resting and and stress perfusion imaging will be performed.

次要结局

  • Left ventricular function(6 months and 3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Use of Shock Wave Therapy for Neo-Vascularisation in... | 临床试验