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

Primary Purpose

Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Radiosurgery of ganglion stellatum
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring radiosurgery, ganglion stellatum, angina pectoris, coronary artery disease, myocardial ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital OstravaRecruiting
  • AGEL Podlesí Hospital TřinecRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiosurgery of Ganglion Stellatum

Arm Description

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

Outcomes

Primary Outcome Measures

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).
Safety of radiosurgery of ganglion stellatum
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
The change of angina pectoris relief drugs will be evaluated
Six-minute walk test improvement
Change in the six-minute walk test will be evaluated before and after the procedure

Full Information

First Posted
October 26, 2022
Last Updated
October 31, 2022
Sponsor
University Hospital Ostrava
Collaborators
Nemocnice AGEL Trinec-Podlesi a.s.
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1. Study Identification

Unique Protocol Identification Number
NCT05600751
Brief Title
Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
Acronym
RELIEF-AP
Official Title
Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
Nemocnice AGEL Trinec-Podlesi a.s.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia
Keywords
radiosurgery, ganglion stellatum, angina pectoris, coronary artery disease, myocardial ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiosurgery of Ganglion Stellatum
Arm Type
Experimental
Arm Description
Patients will undergo radiosurgery of the ganglion stellatum (left one or both)
Intervention Type
Procedure
Intervention Name(s)
Radiosurgery of ganglion stellatum
Intervention Description
Patients will undergo radiosurgery of ganglion stellatum (left one or both)
Primary Outcome Measure Information:
Title
Seattle Angina Questionnaire
Description
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).
Time Frame
24 months
Title
Safety of radiosurgery of ganglion stellatum
Description
Safety of radiosurgery of ganglion stellatum will be observed and assessed according to the occurrence of adverse events
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Usage of angina pectoris relief drugs
Description
The change of angina pectoris relief drugs will be evaluated
Time Frame
24 months
Title
Six-minute walk test improvement
Description
Change in the six-minute walk test will be evaluated before and after the procedure
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD
First Name & Middle Initial & Last Name & Degree
Lukáš Knybel, Ing.,PhD
Facility Name
AGEL Podlesí Hospital Třinec
City
Třinec
State/Province
Moravian-Silesian Region
ZIP/Postal Code
73961
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miroslav Hudec, MD
Phone
558304
Ext
403
Email
miroslav.hudec@nempodlesi.cz
First Name & Middle Initial & Last Name & Degree
Miroslav Hudec, MD
First Name & Middle Initial & Last Name & Degree
Otakar Jiravský, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data may be made available upon request.

Learn more about this trial

Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

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