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| Name | Class |
|---|---|
| Universität Duisburg-Essen | OTHER |
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Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.
The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to myocardial ischemic tissue. Shockwaves are created by a special generator and are focused using a shockwave applicator device. The treatment is guided by standard echocardiography equipment. The shockwaves are delivered in synchronization with Patient R-wave to avoid arrhythmias. The treatment is painless.
At first, the patient undergoes Stress-Echocardiography testing to identify the hypokinetic areas (ischemic areas). Following that, the ischemic areas sre treated with shockwaves. Several treatments are required for optimal results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | A - Treatment group. Patients in this group receive actual shockwave therapy. |
|
| B | Placebo Comparator | Placebo group. This group of patients undergo the same procedure as the treatment group, however shockwaves are not delivered to the heart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec) | Device | Energy Density - 0.09 mJ/mm2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Exercise Time | The primary efficacy endpoint is the change in maximal stress exercise capacity using the modified Bruce exercise test from baseline to the 6 months post-baseline assessment. | 6 months |
| The incidence of adverse events at 12 months post treatment | Incidence of patient complications, adverse reactions and rise in cardiac enzymes, blood count, platelate count renal and hepatic function, and Troponin levels, as well as E.C.G. changes, 12 months post treatment. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Seattle Angina Questionnaire (SAQ) | The change in the SAQ from baseline to 3 months post-treatment or to the last visit for patients who terminate prematurely | 6 months |
| Change in AP-CCS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Lind, MD | Westdeutsches Herzzentrum ,Universität Duisburg/Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westdeutsches Herzzentrum ,Universität Duisburg/Essen | Essen | Germany |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
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| Placebo | Device | Placebo |
|
The AP CCS Stage at the 6 months post-baseline, or to the last visit for patients who terminate prematurely.
| 6 months |
| Change in the Number of angina attacks | The change in the number of angina attacks from baseline to 3 months post-treatment. The number of attacks per week will be documented. | 6 months |
| Change in the Hospital Admission Rate | The change in the number of hospital admission from baseline to 3 months post-treatment. The number of attacks per week will be documented. | 6 months |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |