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RecruitingNCT07068399ClinicalTrials.gov record

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

Coronary Artery Disease

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 80 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
100 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
No masking
CSWT

Cardiac patients who have progressively increasing coronary plaque burden that is not yet at a critical stage of the CAD process and are randomised to the group receiving extracorporeal shock wave therapy. Cardiac MRI scans will be done before the treatment and 6 months after the end of CSWT.

Procedure: Extracorporeal shock wave therapy

No intervention

The other half of similar cardiac patients who do not receive CSWT. Optimised medical therapy will be given to patients in this group. Cardiac MRI scans will be done twice.

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Myocardial perfusion

Time frame: 6 months and 3 weeks

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

Secondary measures

Left ventricular function

Time frame: 6 months and 3 weeks

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

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

HKU Li Ka Shing Faculty of MedicineHong Kong, Hong KongRecruiting

Study team and timeline

Lead sponsor
The University of Hong Kong
Study start
Sep 1, 2020 Actual
Primary completion
Apr 30, 2027 Estimated
Study completion
Apr 30, 2027 Estimated
First posted
Jul 16, 2025 Actual
Last updated
Nov 9, 2026 Actual

Official study contacts

Ming-Yen NG, BMBSCONTACTmyng2@hku.hk22554524
Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026