Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris (RELIEF-AP)
Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring radiosurgery, ganglion stellatum, angina pectoris, coronary artery disease, myocardial ischemia
Eligibility Criteria
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
Sites / Locations
- University Hospital OstravaRecruiting
- AGEL Podlesí Hospital TřinecRecruiting
Arms of the Study
Arm 1
Experimental
Radiosurgery of Ganglion Stellatum
Patients will undergo radiosurgery of the ganglion stellatum (left one or both)