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Trial Title:
Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
NCT ID:
NCT05600751
Condition:
Coronary Artery Disease
Angina Pectoris
Myocardial Ischemia
Conditions: Official terms:
Ganglion Cysts
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Ischemia
Conditions: Keywords:
radiosurgery
ganglion stellatum
angina pectoris
coronary artery disease
myocardial ischemia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Radiosurgery of ganglion stellatum
Description:
Patients will undergo radiosurgery of ganglion stellatum (left one or both)
Arm group label:
Radiosurgery of Ganglion Stellatum
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Ostrava
Address:
City:
Ostrava
Zip:
70852
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Jiří Hynčica
Phone:
0042059737
Phone ext:
2587
Email:
jiri.hyncica@fno.cz
Investigator:
Last name:
Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD
Email:
Principal Investigator
Investigator:
Last name:
Lukáš Knybel, Ing.,PhD
Email:
Sub-Investigator
Facility:
Name:
AGEL Podlesí Hospital Třinec
Address:
City:
Třinec
Zip:
73961
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Miroslav Hudec, MD
Phone:
558304
Phone ext:
403
Email:
miroslav.hudec@nempodlesi.cz
Investigator:
Last name:
Miroslav Hudec, MD
Email:
Principal Investigator
Investigator:
Last name:
Otakar Jiravský, MD
Email:
Sub-Investigator
Start date:
January 1, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
University Hospital Ostrava
Agency class:
Other
Collaborator:
Agency:
Nemocnice AGEL Trinec-Podlesi a.s.
Agency class:
Other
Source:
University Hospital Ostrava
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05600751
