Clinical trial NCT05600751: Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
Official title: Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Angina Pectoris
Myocardial Ischemia
Keywords: radiosurgery
ganglion stellatum
angina pectoris
coronary artery disease
myocardial ischemia
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: Nemocnice AGEL Trinec-Podlesi a.s.
First posted: 2022-10-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Seattle Angina Questionnaire
timeFrame: 24 months
measure: Safety of radiosurgery of ganglion stellatum
timeFrame: 24 months
Secondary outcomes:
measure: Usage of angina pectoris relief drugs
timeFrame: 24 months
measure: Six-minute walk test improvement
timeFrame: 24 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
city: Třinec
country: Czechia
facility: AGEL Podlesí Hospital Třinec
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD
role: PRINCIPAL_INVESTIGATOR
References: