Spots Global Cancer Trial Database for Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

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Trial Identification

Brief Title: Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

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

Study ID: NCT05600751

Conditions

Coronary Artery Disease

Angina Pectoris

Myocardial Ischemia

Interventions

Radiosurgery of ganglion stellatum

Study Description

Brief Summary: 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: 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