Overview
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.
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
Eligibility
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