Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT04276220
Status:
COMPLETED
Last Update Posted:
2025-08-15
First Post:
2020-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C567782', 'term': 'Amyloidosis, Hereditary, Transthyretin-Related'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of wild-type transthyretin cardiac amyloidosis in patients undergoing surgery for idiopathic Carpal Tunnel Syndrome Surgery where biopsies from transverse carpal ligament stain positive for amyloid.', 'timeFrame': 'Through study completion, 6 years.', 'description': 'We will examine the amyloid deposits prevalence in biopsies from the Carpal Tunnel and ATTRwt prevalence in an aged and predominantly male population operated for idiopathic Carpal Tunnel Syndrom. Diagnosis of wild-type cardiac amyloidosis will be determined by TC99-DPD scintigraphy, endomyocardial biopsy, or both. Biopsies will be examined using Congo Red staining and fluorescent light'}], 'secondaryOutcomes': [{'measure': 'Levels of transthyretin in blood and urine from patients with suspected wild-type transthyretin cardiac amyloidosis', 'timeFrame': 'Has been added after study start, will run through study completion, 3 years.', 'description': 'We will investigate the plasma and urine levels of different forms of TTR (total TTR, misTTR, and fragTTR) in patients with amyloid deposits in the transverse carpal ligament, patients subsequently diagnosed with ATTRwt-CM and in patients with already diagnosed ATTRwt matched age and gender.\n\nWe will investigate whether the levels of TTR is higher among ligament amyloid positive patients that are subsequently diagnosed ATTRwt-CM as compared to those without ATTR-CM.'}, {'measure': 'Comparing patients diagnosed with wild-type transthyretin cardiac amyloidosis due to screening with age and gender matched clinically diagnosed ATTRwt patients.', 'timeFrame': 'Through study completion, 6 years.', 'description': 'Compare NAC-stage, NYHA-class, LVEF ect.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transthyretin Amyloidosis', 'Transthyretin Cardiac Amyloidosis', 'Wild-Type Transthyretin-Related (ATTR)Amyloidosis']}, 'descriptionModule': {'briefSummary': 'Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination including blod- and urine samples examined for transthyretin.\n\nIf the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test.\n\nMyocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males above 65 years of age, females above 75 years of age.\n* Scheduled idiopathic carpal tunnel release surgery.\n* Informed written consent.\n\nExclusion Criteria:\n\n* Operation by other indication, e.g.\n* Fracture\n* Ganglion\n* Known amyloidosis'}, 'identificationModule': {'nctId': 'NCT04276220', 'acronym': 'CACTuS2', 'briefTitle': 'Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital Skejby'}, 'officialTitle': 'Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study', 'orgStudyIdInfo': {'id': '1-10-72-178-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tenosynovial Biopsy', 'interventionNames': ['Diagnostic Test: Tenosynovial biopsy']}], 'interventions': [{'name': 'Tenosynovial biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.', 'armGroupLabels': ['Tenosynovial Biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Jylland', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steen Hvitfeldt Poulsen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, DMSc', 'investigatorFullName': 'Steen Hvitfeldt Poulsen', 'investigatorAffiliation': 'Aarhus University Hospital Skejby'}}}}