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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Angina Pectoris
• Intervention / Treatment: Procedure: Radiosurgery of ganglion stellatum

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • Recruiting
      • University Hospital Ostrava
      • Contact: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz
      • Principal Investigator: Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD
      • Sub-Investigator: Lukáš Knybel, Ing.,PhD
    • Třinec, Moravian-Silesian Region, Czechia, 73961
      • Recruiting
      • AGEL Podlesí Hospital Třinec
      • Contact: Miroslav Hudec, MD; Phone Number: 403 558304; Email: miroslav.hudec@nempodlesi.cz
      • Principal Investigator: Miroslav Hudec, MD
      • Sub-Investigator: Otakar Jiravský, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seattle Angina Questionnaire	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).	24 months
Safety of radiosurgery of ganglion stellatum	Safety of radiosurgery of ganglion stellatum will be observed and assessed according to the occurrence of adverse events	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Collaborators: Nemocnice AGEL Trinec-Podlesi a.s.
• Investigators: Principal Investigator: Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD, University Hospital Ostrava

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: coronary artery disease; angina pectoris; radiosurgery; myocardial ischemia; ganglion stellatum
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neoplasms; Pain; Neurologic Manifestations; Cysts; Connective Tissue Diseases; Mucinoses; Chest Pain; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Angina Pectoris; Ganglion Cysts
• Other Study ID Numbers: RELIEF-AP Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data may be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No