Radiosurgery for treating severe chest pain in heart disease patients

Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

This study is testing if a special type of surgery can help people with severe chest pain from heart disease who haven't found relief from other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital Ostrava (other)
• Locations: 2 sites (Ostrava, Moravian-Silesian Region and 1 other locations)
• Trial ID: NCT05600751 on ClinicalTrials.gov

What this trial studies

This interventional trial investigates the effectiveness of radiosurgery on the stellate ganglion in patients suffering from refractory angina pectoris, who have exhausted other treatment options. The study involves a prospective design where patients will undergo radiosurgery after confirming their response to anesthetic blockade of the left stellate ganglion. If symptoms persist after three months, the right stellate ganglion may also be treated. The primary endpoints include improvements in angina symptoms measured by the Seattle Angina Questionnaire and safety assessments, with a follow-up period of two years.

Who should consider this trial

Good fit: Ideal candidates are adults with coronary artery disease and refractory angina pectoris who have maximized medication therapy and revascularization options.

Not a fit: Patients with a life expectancy of less than 24 months or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief from severe chest pain for patients with limited options.

How similar studies have performed: While the approach of using radiosurgery for this condition is novel, similar interventions targeting nerve pathways have shown promise in other studies.

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

Where this trial is running

Ostrava, Moravian-Silesian Region and 1 other locations

• University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (RECRUITING)
• AGEL Podlesí Hospital Třinec — Třinec, Moravian-Silesian Region, Czechia (RECRUITING)

Study contacts

• Principal investigator: Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD — University Hospital Ostrava
• Study coordinator: Jiří Hynčica

Conditions: Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia, radiosurgery, ganglion stellatum, angina pectoris, coronary artery disease, myocardial ischemia