Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

Status: Recruiting
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Contact Information
Primary
Jiří Hynčica
jiri.hyncica@fno.cz
0042059737
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 10
Treatments
Experimental: Radiosurgery of Ganglion Stellatum
Patients will undergo radiosurgery of the ganglion stellatum (left one or both)
Sponsors
Leads: University Hospital Ostrava
Collaborators: Nemocnice AGEL Trinec-Podlesi a.s.

This content was sourced from clinicaltrials.gov