Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-01 @ 4:53 PM
Study NCT ID:
NCT05600751
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2022-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seattle Angina Questionnaire', 'timeFrame': '24 months', '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).'}, {'measure': 'Safety of radiosurgery of ganglion stellatum', 'timeFrame': '24 months', 'description': 'Safety of radiosurgery of ganglion stellatum will be observed and assessed according to the occurrence of adverse events'}], 'secondaryOutcomes': [{'measure': 'Usage of angina pectoris relief drugs', 'timeFrame': '24 months', 'description': 'The change of angina pectoris relief drugs will be evaluated'}, {'measure': 'Six-minute walk test improvement', 'timeFrame': '24 months', 'description': 'Change in the six-minute walk test will be evaluated before and after the procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiosurgery', 'ganglion stellatum', 'angina pectoris', 'coronary artery disease', 'myocardial ischemia'], 'conditions': ['Coronary Artery Disease', 'Angina Pectoris', 'Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Design: prospective, interventional trial (University Hospital Ostrava, Cardiocentre AGEL Podlesi Hospital Trinec)\n\n* radiosurgery of left GS after confirmation of responding to anesthetic blockade\n* 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)\n* Seattle Angina Questionary (SAQ) and amount of nitrate usage for responding confirmation\n* Radiotherapy 40 Gy\n* 2-year follow-up\n* Scheduled follow-up visits: 1, 3, 6, 12, and 24 months (24)\n\nPreliminary examination: selective coronary angiography, transthoracic echocardiography, stress test, 6 min walk test, SAQ (19-item)\n\nEndopoints:\n\nPrimary Endpoints: SAQ, safety of the radiosurgery of GS Secondary Endpoints:usage decrease of angina relief drugs, 6 min walk test improvement\n\nFollow-up visits examination, Restage: 6 min walk test, SAQ, amount of nitrate usage, ECG, blood tests incl. NT-proBNP, NSE'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have coronary artery disease (CAD) with refractory angina pectoris (AP).\n* Patients must have a maximum of tolerated medication therapy of angina pectoris available.\n* Patients must have done the maximum possible revascularization of CAD.\n* Two certificated independent interventional cardiologists and two cardiac surgeons must conclude that further revascularization (including CABG) is not possible/not effective/ with high risk.\n* Age ≥ 18 years.\n* Patients must have any stress test with proof of myocardial ischemia (dobutamine echocardiography, gated Tc-SPECT of myocardium).\n* Life expectancy at least 24 months (not limited due to severe comorbidities)\n* Patients must be responders of anesthetic blockade of the left stellate ganglion (GS) - clinically significant relief of AP symptoms after blockade at least twice.\n* Patients must provide verbal and written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Life expectancy less than 24 months\n* Non-responders of anesthetic blockade of GS\n* Impossibility to undergo a stress test.\n* Myocardial infarction in last 4 weeks\n* Heart failure - class IV NYHA\n* Unwillingness to participate or inability to comply with the protocol for the duration of the study\n* Patients who are pregnant, and patients with reproductive capability will need to use adequate contraception during the time of participation in the study\n* History of radiotherapy in the head and neck region'}, 'identificationModule': {'nctId': 'NCT05600751', 'acronym': 'RELIEF-AP', 'briefTitle': 'Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Radiosurgery of Ganglion StELlatum In Patients With REFractory Angina Pectoris', 'orgStudyIdInfo': {'id': 'RELIEF-AP Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiosurgery of Ganglion Stellatum', 'description': 'Patients will undergo radiosurgery of the ganglion stellatum (left one or both)', 'interventionNames': ['Procedure: Radiosurgery of ganglion stellatum']}], 'interventions': [{'name': 'Radiosurgery of ganglion stellatum', 'type': 'PROCEDURE', 'description': 'Patients will undergo radiosurgery of ganglion stellatum (left one or both)', 'armGroupLabels': ['Radiosurgery of Ganglion Stellatum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70852', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '0042059737', 'phoneExt': '2587'}, {'name': 'Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lukáš Knybel, Ing.,PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '73961', 'city': 'Třinec', 'state': 'Moravian-Silesian Region', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Miroslav Hudec, MD', 'role': 'CONTACT', 'email': 'miroslav.hudec@nempodlesi.cz', 'phone': '558304', 'phoneExt': '403'}, {'name': 'Miroslav Hudec, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Otakar Jiravský, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'AGEL Podlesí Hospital Třinec', 'geoPoint': {'lat': 49.67763, 'lon': 18.67078}}], 'centralContacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '0042059737', 'phoneExt': '2587'}], 'overallOfficials': [{'name': 'Jakub Cvek, Assoc.Prof.,MD,Ing.,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data may be made available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nemocnice AGEL Trinec-Podlesi a.s.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}