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

NCT07068399 | Recruiting

• 1 other identifier: UW 19-651
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Stress Cardiac Magnetic Resonance; Cardiac Extracorporeal Shock Wave Therapy

Outcome Measures

Primary Outcomes (1)

• Myocardial perfusion

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

  6 months and 3 weeks

Secondary Outcomes (1)

• Left ventricular function

  6 months and 3 weeks

Study Arms (2)

CSWT

EXPERIMENTAL

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

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.

Interventions

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.

Also known as: CSWT, Cardiac ESWT

CSWT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

HKU Li Ka Shing Faculty of Medicine

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Ming-Yen NG, BMBS

CONTACT

22554524; myng2@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: September 1, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-02

Locations

HK (1)