Coronary Artery DiseaseCSWTNCT07068399
Use of Shock Wave Therapy for Neo-Vascularisation in Non-critical Coronary Artery Disease: Validation by Quantitative Cardiac MRI Perfusion
A study testing Extracorporeal shock wave therapy in people with Coronary Artery Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Extracorporeal shock wave therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2020to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptoms of coronary artery disease
- Patients without obstructive coronary artery disease
- with LVEF not < 40%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
HKU Li Ka Shing Faculty of Medicine
Hong Kong
Ming-Yen NG, BMBS, 22554524, myng2@hku.hk
About this study
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 detailed 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Extracorporeal shock wave therapy
- Keywords
- Stress Cardiac Magnetic Resonance, Cardiac Extracorporeal Shock Wave Therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapyProcedure or surgery
Also called CSWT, Cardiac ESWT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion
Quantitative magnetic resonance imaging with resting and and stress perfusion imaging will be performed.
Measured: 6 months and 3 weeks
Secondary outcomes (1)
Left ventricular function
Quantitative magnetic resonance imaging with resting and and stress perfusion imaging will be performed
Measured: 6 months and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Sep 2020
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068399
- Sponsor's protocol ID
- UW 19-651
- Acronym
- CSWT
- Status last verified
- Feb 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Shock Wave Therapy for Neo-Vascularisation in Non-critical Coronary Artery Disease: Validation by Quantitative Cardiac MRI Perfusion
- ClinicalTrials.gov ID
- NCT07068399
- Acronym / sponsor ID
- CSWT / UW 19-651
- Conditions
- Coronary Artery Disease
- Keywords
- Stress Cardiac Magnetic Resonance, Cardiac Extracorporeal Shock Wave Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| CSWT | Experimental | Procedure: Extracorporeal shock wave therapyCardiac 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with symptoms of coronary artery disease
- Patients without obstructive coronary artery disease
- with LVEF not < 40%.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock wave therapyAlso: CSWT, Cardiac ESWTExtracorporeal 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. | Procedure or surgery | CSWT |
Primary outcome
Myocardial perfusion
Time frame: 6 months and 3 weeks
Quantitative magnetic resonance imaging with resting and and stress perfusion imaging will be performed.
1 secondary outcome
Left ventricular function
Time frame: 6 months and 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy in people with Coronary Artery Disease, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yen NG, BMBS (22554524, myng2@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial perfusion (time frame: 6 months and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.