Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
NCT ID: NCT05600751
Last Updated: 2024-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
10 participants
INTERVENTIONAL
2022-01-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Radiofrequency Ablation (RFA) in Breast Tumors
NCT04389216
Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients
NCT04896242
Radiation Therapy in Treating Patients With Aggressive Fibromatoses
NCT00030680
Effectiveness of Stereotactic RadioTherapy in Solid Primary Inoperable and Oligometastatic Cancer
NCT03461822
Monitoring Radiobiological Effects in Thoracic Malignancy by Using Myocardial Perfusion Scan
NCT01913769
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Radiosurgery of Ganglion Stellatum
Patients will undergo radiosurgery of the ganglion stellatum (left one or both)
Radiosurgery of ganglion stellatum
Patients will undergo radiosurgery of ganglion stellatum (left one or both)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Radiosurgery of ganglion stellatum
Patients will undergo radiosurgery of ganglion stellatum (left one or both)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nemocnice AGEL Trinec-Podlesi a.s.
OTHER
University Hospital Ostrava
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
AGEL Podlesí Hospital Třinec
Třinec, Moravian-Silesian Region, Czechia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RELIEF-AP Trial
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.