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| Name | Class |
|---|---|
| Nemocnice AGEL Trinec-Podlesi a.s. | OTHER |
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The core hypothesis to be tested is that the radiosurgery of stellate ganglion (left one or both if left-sided without full relief of symptoms) is an effective therapy of refractory angina pectoris in patients with no other therapeutic options - proof of concept study.
Design: prospective, interventional trial (University Hospital Ostrava, Cardiocentre AGEL Podlesi Hospital Trinec)
Preliminary examination: selective coronary angiography, transthoracic echocardiography, stress test, 6 min walk test, SAQ (19-item)
Endopoints:
Primary Endpoints: SAQ, safety of the radiosurgery of GS Secondary Endpoints:usage decrease of angina relief drugs, 6 min walk test improvement
Follow-up visits examination, Restage: 6 min walk test, SAQ, amount of nitrate usage, ECG, blood tests incl. NT-proBNP, NSE
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiosurgery of Ganglion Stellatum | Experimental | Patients will undergo radiosurgery of the ganglion stellatum (left one or both) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiosurgery of ganglion stellatum | Procedure | Patients will undergo radiosurgery of ganglion stellatum (left one or both) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seattle Angina Questionnaire | The Seattle Angina Questionnaire is a cardiac disease-related quality-of-life measure with 19 items. A lower score corresponds to a lower level of functioning. The scores are classified as "minimal (scores 75-100), mild (50-74), moderate (25-49), and severe (0-24). | 24 months |
| Safety of radiosurgery of ganglion stellatum | Safety of radiosurgery of ganglion stellatum will be observed and assessed according to the occurrence of adverse events | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Usage of angina pectoris relief drugs | The change of angina pectoris relief drugs will be evaluated | 24 months |
| Six-minute walk test improvement | Change in the six-minute walk test will be evaluated before and after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiří Hynčica | Contact | 0042059737 | 2587 | jiri.hyncica@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
Individual participant data may be made available upon request.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| 24 months |
| AGEL Podlesí Hospital Třinec | Recruiting | Třinec | Moravian-Silesian Region | 73961 | Czechia |
|
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |