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| Name | Class |
|---|---|
| Academisch Ziekenhuis Maastricht | 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 treatment session (9 in total, spread over 9 weeks) are required for optimal results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Treatment group. Patients in this group receive actual shockwave therapy. |
|
| 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 |
|---|---|---|
| Time to Angina | Change in time to angina using the modified Bruce exercise test from baseline to the 6 months post baseline assessment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SPECT | The change in perfusion in pharmacological induced stress SPECT test (at rest and at stress) from baseline to 6 months post baseline (17 segment model) | 6 months |
| Change in AP-CCS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Johannes Waltenberger, MD, PhD | Academisch Ziekenhuis Maastricht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Ziekenhuis Maastricht | Maastricht | Netherlands |
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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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The AP-CCS stage at the 6 months post baseline.
| 6 months |
| Total Exercise time | The change in total exercise time (Exercise Tolerance Test- ETT) from baseline to 6 months post baseline. | 6 months |
| Number of Angina attacks (patient diary) | The change in the number of angina attacks from baseline to 6 months post baseline. 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 |