Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Angina Pectoris; Myocardial Ischemia
• Interventions: Procedure: Radiosurgery of ganglion stellatum

• Registration Number: NCT05600751
• Lead Sponsor: University Hospital Ostrava

Brief 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.

Detailed Description

Design: prospective, interventional trial (University Hospital Ostrava, Cardiocentre AGEL Podlesi Hospital Trinec)

* radiosurgery of left GS after confirmation of responding to anesthetic blockade

* in case of remaining AP after three months, radiosurgery of right GS in case of response confirmation to anesthetic blockade (patients must be responders of anesthetic blockade of left stellate ganglion)

* Seattle Angina Questionary (SAQ) and amount of nitrate usage for responding confirmation

* Radiotherapy 40 Gy

* 2-year follow-up

* Scheduled follow-up visits: 1, 3, 6, 12, and 24 months (24)

Preliminary examination: selective coronary angiography, transthoracic echocardiography, stress test, 6 min walk test, SAQ (19-item)

Endopoints:

Primary Endpoints: SAQ, safety of the radiosurgery of GS Secondary Endpoints:usage decrease of angina relief drugs, 6 min walk test improvement

Follow-up visits examination, Restage: 6 min walk test, SAQ, amount of nitrate usage, ECG, blood tests incl. NT-proBNP, NSE

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiosurgery of Ganglion Stellatum	Radiosurgery of ganglion stellatum	Patients will undergo radiosurgery of the ganglion stellatum (left one or both)

Primary Outcome Measures

Name	Time	Method
Safety of radiosurgery of ganglion stellatum	24 months	Safety of radiosurgery of ganglion stellatum will be observed and assessed according to the occurrence of adverse events
Seattle Angina Questionnaire	24 months	The Seattle Angina Questionnaire is a cardiac disease-related quality-of-life measure with 19 items. A lower score corresponds to a lower level of functioning. The scores are classified as "minimal (scores 75-100), mild (50-74), moderate (25-49), and severe (0-24).

Secondary Outcome Measures

Name	Time	Method
Usage of angina pectoris relief drugs	24 months	The change of angina pectoris relief drugs will be evaluated
Six-minute walk test improvement	24 months	Change in the six-minute walk test will be evaluated before and after the procedure

Trial Locations

Locations (2)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia

AGEL Podlesí Hospital Třinec; 🇨🇿 Třinec, Moravian-Silesian Region, Czechia