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NCT05600751
Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
Conditions: Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 10
Sponsor: University Hospital Ostrava
Location: Czechia
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.
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 monthsNon-responders of anesthetic blockade of GSImpossibility to undergo a stress test.Myocardial infarction in last 4 weeksHeart failure - class IV NYHAUnwillingness to participate or inability to comply with the protocol for the duration of the studyPatients who are pregnant, and patients with reproductive capability will need to use adequate contraception during the time of participation in the studyHistory of radiotherapy in the head and neck region
Source: ClinicalTrials.gov (NCT05600751). StuddyBuddy aggregates publicly available trial information.