Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

Launched by UNIVERSITY HOSPITAL OSTRAVA · Oct 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients suffering from severe chest pain, known as refractory angina pectoris, caused by coronary artery disease. The researchers want to see if a procedure called radiosurgery, targeting a specific nerve cluster in the neck called the stellate ganglion, can help relieve this pain when other treatments have not worked. This study is looking for participants aged 18 and older who have tried the maximum amount of medications and have had all possible heart surgeries but still experience significant chest pain. Additionally, participants need to show that they respond well to a temporary nerve block in the stellate ganglion that reduces their pain.

If you or a loved one qualifies for this trial, you can expect to undergo the radiosurgery procedure, which is intended to provide pain relief. Before participating, there will be thorough discussions to ensure you understand the process, and you will need to give both verbal and written consent. It's important to know that participants will also need to have a life expectancy of at least 24 months and must not have had a recent heart attack or severe heart failure. The goal of this study is to determine if this innovative approach can help improve the quality of life for patients with limited treatment options.

Gender

ALL

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