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

University Hospital Ostrava

Status

Enrolling

Conditions

Coronary Artery Disease

Myocardial Ischemia

Angina Pectoris

Treatments

Procedure: Radiosurgery of ganglion stellatum

Study type

Interventional

Funder types

Other

Identifiers

NCT05600751

RELIEF-AP Trial

Details and patient eligibility

About

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.

Full 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

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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