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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial perfusion | Quantitative magnetic resonance imaging with resting and and stress perfusion imaging will be performed. | 6 months and 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular function | Quantitative magnetic resonance imaging with resting and and stress perfusion imaging will be performed | 6 months and 3 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Yen NG, BMBS | Contact | 22554524 | myng2@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HKU Li Ka Shing Faculty of Medicine | Recruiting | Hong Kong | Hong Kong |
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Randomised controlled trial
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|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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