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| Name | Class |
|---|---|
| Hadassah Medical Organization | 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- SPECT testing to identify the ischemic areas. Following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SPECT | 6 months | |
| Change in AP-CCS | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Leibowitz, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah-Hebrew University Medical Center | Jerusalem | Israel |
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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 |
|
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |