RELIEF-AP: Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

Sponsor

University Hospital Ostrava (Other)

Overall Status

Recruiting

CT.gov ID

NCT05600751

Collaborator

Nemocnice AGEL Trinec-Podlesi a.s. (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Angina Pectoris Myocardial Ischemia	Procedure: Radiosurgery of ganglion stellatum	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiosurgery of Ganglion Stellatum Patients will undergo radiosurgery of the ganglion stellatum (left one or both)	Procedure: Radiosurgery of ganglion stellatum Patients will undergo radiosurgery of ganglion stellatum (left one or both)

Arm

Intervention/Treatment

Experimental: Radiosurgery of Ganglion Stellatum

Patients will undergo radiosurgery of the ganglion stellatum (left one or both)

Procedure: Radiosurgery of ganglion stellatum

Patients will undergo radiosurgery of ganglion stellatum (left one or both)

Outcome Measures

Primary Outcome Measures

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).
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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