Coronary Artery DiseaseRELIEF-APNCT05600751
Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
A study testing Radiosurgery of ganglion stellatum in people with Coronary Artery Disease and Angina Pectoris, run by University Hospital Ostrava at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia
- What is being tested?
- Radiosurgery of ganglion stellatum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Jan 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD
- Recruiting
AGEL Podlesí Hospital Třinec
Třinec, Moravian-Silesian Region, 73961
Miroslav Hudec, MD, 558304 ext. 403, miroslav.hudec@nempodlesi.cz
Miroslav Hudec, MD
About this study
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.
Read the 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
- Being tested
- Radiosurgery of ganglion stellatum
- Keywords
- radiosurgery, ganglion stellatum, angina pectoris, coronary artery disease, myocardial ischemia
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiosurgery of ganglion stellatumProcedure or surgery
Patients will undergo radiosurgery of ganglion stellatum (left one or both)
| Study group | Role | What they receive |
|---|---|---|
| Radiosurgery of Ganglion Stellatum | Experimental | Patients will undergo radiosurgery of the ganglion stellatum (left one or both) Receives: Procedure: Radiosurgery of ganglion stellatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 24 months
Secondary outcomes (2)
Usage of angina pectoris relief drugs
The change of angina pectoris relief drugs will be evaluated
Measured: 24 months
Six-minute walk test improvement
Change in the six-minute walk test will be evaluated before and after the procedure
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Jan 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- Nemocnice AGEL Trinec-Podlesi a.s.
- Responsible party
- Sponsor
- Investigators
- Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600751
- Sponsor's protocol ID
- RELIEF-AP Trial
- Acronym
- RELIEF-AP
- Status last verified
- Jan 2024
- First submitted
- 26 Oct 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data may be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
- ClinicalTrials.gov ID
- NCT05600751
- Acronym / sponsor ID
- RELIEF-AP / RELIEF-AP Trial
- Keywords
- radiosurgery, ganglion stellatum, angina pectoris, coronary artery disease, myocardial ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- Nemocnice AGEL Trinec-Podlesi a.s.
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiosurgery of Ganglion Stellatum | Experimental | Procedure: Radiosurgery of ganglion stellatumPatients will undergo radiosurgery of the ganglion stellatum (left one or both) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiosurgery of ganglion stellatumPatients will undergo radiosurgery of ganglion stellatum (left one or both) | Procedure or surgery | Radiosurgery of Ganglion Stellatum |
Primary outcome
Seattle Angina Questionnaire
Time frame: 24 months
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
Time frame: 24 months
Safety of radiosurgery of ganglion stellatum will be observed and assessed according to the occurrence of adverse events
2 secondary outcomes
Usage of angina pectoris relief drugs
Time frame: 24 months
Six-minute walk test improvement
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No. Individual participant data may be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD principal investigator
University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiosurgery of ganglion stellatum in people with Coronary Artery Disease and Angina Pectoris, run by University Hospital Ostrava at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle Angina Questionnaire (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.