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| Name | Class |
|---|---|
| Medispec ltd. | UNKNOWN |
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There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shockwave treatment | Procedure | 9 treatments in 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of exercise tolerance | Modified Bruce protocol, changes compared to the baseline | after 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of myocardial perfusion | myocardial perfusion scintigraphy changes compared to the baseline | 6 months |
| Number of Patients with Adverse Events as a Measure of Safety | Changes in electrocardiogram and cardiac enzymes (e.g. creatininekinase, troponin), clinical status and chestpain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jindra Vainer, MD | Contact | +31433875106 | J.Vainer@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| H. Crijns, Prof Dr. | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Recruiting | Maastricht | Limburg | 6229HX | Netherlands |
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| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 6 months |
| Improvement of quality of life | Number of anginal attacks/week, use of nitrates/week | 6 months |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |