Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

Study Overview
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Brief Summary
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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.

Detailed Description
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Design: prospective, interventional trial (University Hospital Ostrava, Cardiocentre AGEL Podlesi Hospital Trinec) radiosurgery of left GS after confirmation of responding to anesthetic blockade in case of remaining AP after three months, radiosurgery of right GS in case of response confirmation to anesthetic blockade (patients must be responders of anesthetic blockade of left stellate ganglion) Seattle Angina Questionary (SAQ) and amount of nitrate usage for responding confirmation Radiotherapy 40 Gy 2-year follow-up Scheduled follow-up visits: 1, 3, 6, 12, and 24 months (24) 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

Official Title
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Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

Conditions
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Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia

Intervention / Treatment
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* Procedure: Radiosurgery of ganglion stellatum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have coronary artery disease (CAD) with refractory angina pectoris (AP). Patients must have a maximum of tolerated medication therapy of angina pectoris available. Patients must have done the maximum possible revascularization of CAD. Two certificated independent interventional cardiologists and two cardiac surgeons must conclude that further revascularization (including CABG) is not possible/not effective/ with high risk. Age ≥ 18 years. Patients must have any stress test with proof of myocardial ischemia (dobutamine echocardiography, gated Tc-SPECT of myocardium). Life expectancy at least 24 months (not limited due to severe comorbidities) Patients must be responders of anesthetic blockade of the left stellate ganglion (GS) - clinically significant relief of AP symptoms after blockade at least twice. Patients must provide verbal and written informed consent to participate in the study. Exclusion Criteria: Life expectancy less than 24 months Non-responders of anesthetic blockade of GS Impossibility to undergo a stress test. Myocardial infarction in last 4 weeks Heart failure - class IV NYHA Unwillingness to participate or inability to comply with the protocol for the duration of the study Patients who are pregnant, and patients with reproductive capability will need to use adequate contraception during the time of participation in the study History of radiotherapy in the head and neck region

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiosurgery of Ganglion Stellatum<br>Patients will undergo radiosurgery of the ganglion stellatum (left one or both) | Procedure: Radiosurgery of ganglion stellatum<br>* Patients will undergo radiosurgery of ganglion stellatum (left one or both)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiosurgery, ganglion stellatum, angina pectoris, coronary artery disease, myocardial ischemia