Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris

NCT05600751 | Unknown

• 1 other identifier: RELIEF-AP Trial
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Ischemia

Keywords

radiosurgery; ganglion stellatum; angina pectoris; coronary artery disease; myocardial ischemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Usage of angina pectoris relief drugs

  24 months

• Six-minute walk test improvement

  24 months

Study Arms (1)

Radiosurgery of Ganglion Stellatum

EXPERIMENTAL

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

Procedure: Radiosurgery of ganglion stellatum

Interventions

Radiosurgery of ganglion stellatum PROCEDURE

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

Radiosurgery of Ganglion Stellatum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• Nemocnice AGEL Trinec-Podlesi a.s.: collaborator

Study Sites (2)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

AGEL Podlesí Hospital Třinec

Třinec, Moravian-Silesian Region, 73961, Czechia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)