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NCT Number: NCT07068399

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HKU Li Ka Shing Faculty of Medicine

Hong Kong

Location status: Recruiting

Location contact

Ming-Yen NG, BMBS

CONTACT

[email protected]

22554524

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Extracorporeal Shock Wave Therapy

Procedure

Extracorporeal shock wave therapy (ESWT) delivers acoustic energy transmitted through liquid medium to internal body tissues. The intervention group will receive a total of 9 ESWT treatment sessions and 200 shocks will be applied to each ischaemic zone of myocardium for 3 times a week on the three weeks that the patients receive ESWT.

Other names: CSWT, Cardiac ESWT

Primary outcomes

  1. Myocardial perfusion

    Time frame: 6 months and 3 weeks

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

Secondary outcomes

  1. Left ventricular function

    Time frame: 6 months and 3 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ming-Yen NG, BMBS

CONTACT

[email protected]

22554524

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Acronym: CSWT

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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