Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-30 @ 2:33 AM
Study NCT ID:
NCT06149195
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-24
First Post:
2023-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-MFBG Cardiac Imaging for Heart Failure Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'observe the 18F-MFBG distribution of the myocardium in heart failure patients', 'timeFrame': '1 year', 'description': '18F-MFBG PET cardiac sympathetic nerve imaging was performed after injection of 30 minutes and 3 hours. The imaging agent distribution of left ventricular walls was observed at three axis positions (short axis, horizontal long axis, and vertical long axis). Target heart maps (17 segments) were obtained using Cedars QPS software to obtain radiation distribution counts (SMSe, SMSlate).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rest Gated Myocardial Perfusion Imaging in Heart Failure']}, 'descriptionModule': {'briefSummary': 'The clinical feasibility of 18F-FMBG cardiac PET imaging will be observed in sympathetic nervous system activity in patients with heart failure, predicted cardiac events, guided ICD implantation, and evaluated therapy efficiency.', 'detailedDescription': 'This is a prospective, single-center clinical study, using18F-meta-fluorobenzylguanidine (18F-MFBG) cardiac PET imaging to present the sympathetic nerve status in heart failure, including ICD implantation. Through follow-up, we analyze the correlation between the distribution of the tracer in the heart and the functions and progression of the patients, including the occurrence of ventricular arrhythmias and sudden cardiac death, And further investigate the guiding value of 18F-MFBG cardiac sympathetic nerve imaging in the screening of ICD implantation patients, including primary and secondary prevention, reducing the cost of ICD implantation and related complications. Furthermore, to evaluate the therapy efficacy for these patients with heart failure using 18F-MFBG cardiac imaging has been considered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'enrolling patients with chronic heart failure with a heart function of NYHA Class II-III.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Clinically confirmed patient with chronic heart failure, LVEF ≤ 40%, cardiac function NYHA 2-3 grade, survival period greater than 1 year, evaluated by the Heart Failure Center of Sichuan Provincial People's Hospital.\n* 2\\. Chronic heart failure patients were evaluated by the Cardiology Department of Sichuan Provincial People's Hospital 5-10 days before ICD implantation.\n* 3\\. All patients above have signed an informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Heart failure, heart function NYHA levels ⅠOR Ⅳ.\n* 2\\. The patient has already implanted ICD or CRT.\n* 3\\. Heart transplant patients.\n* 4\\. Patients with malignant tumors.\n* 5\\. Heart valve disease.\n* 6\\. Myocardial infarction occurred within the past three months.\n* 7\\. The patient has contraindications for ICD implantation surgery.\n* 8\\. The patient does not cooperate or is unwilling to conduct the study."}, 'identificationModule': {'nctId': 'NCT06149195', 'briefTitle': '18F-MFBG Cardiac Imaging for Heart Failure Administration', 'organization': {'class': 'OTHER', 'fullName': "Sichuan Provincial People's Hospital"}, 'officialTitle': '18F-meta-fluorobenzylguanidine Cardiac Imaging for Evaluation of Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'CMFBG202311'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'positive', 'description': 'positive imaging, referring to the tracer absented in the left myocardium whether diffuse or localized on 18F-FMBG cardiac imaging.', 'interventionNames': ['Diagnostic Test: Standard medical care for heart failure']}], 'interventions': [{'name': 'Standard medical care for heart failure', 'type': 'DIAGNOSTIC_TEST', 'description': "Standard treatment and care for heart failure patients from the heart failure center of Sichuan Provincial People's Hospital.", 'armGroupLabels': ['positive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Zhi Ling Ding', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Zhi Ling Ding', 'role': 'STUDY_DIRECTOR', 'affiliation': "China, Sichuan Departments of Nuclear Medicine, Sichuan Provincial People's Hospita"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sichuan Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate senior physician', 'investigatorFullName': 'Hao Wang', 'investigatorAffiliation': "Sichuan Provincial People's Hospital"}}}}