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) * 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will undergo radiosurgery of ganglion stellatum (left one or both)
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
RECRUITINGAGEL Podlesí Hospital Třinec
Třinec, Moravian-Silesian Region, Czechia
RECRUITINGSeattle 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).
Time frame: 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
Time frame: 24 months
Usage of angina pectoris relief drugs
The change of angina pectoris relief drugs will be evaluated
Time frame: 24 months
Six-minute walk test improvement
Change in the six-minute walk test will be evaluated before and after the procedure
Time frame: 24 months
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