NCT05600751

Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Coronary Artery Disease
• Angina Pectoris
• Myocardial Ischemia

Interventions

Type	Name	Description
PROCEDURE	Radiosurgery of ganglion stellatum	Patients will undergo radiosurgery of ganglion stellatum (left one or both)

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-10-31
• Last updated: 2024-01-18

Locations

2 sites across 1 country: Czechia