Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris (NCT05600751) | Clinical Trial Compass
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Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
Czechia10 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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