Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-18 @ 3:22 PM
Study NCT ID:
NCT02041832
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2013-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2013-11-28', 'studyFirstSubmitQcDate': '2014-01-18', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation between biomarkers and incidence of atrial fibrillation', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'First episode of atrial fibrillation', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Correlation between echocardiographic parameters and incidence of atrial fibrillation', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arterial Hypertension', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29759838', 'type': 'DERIVED', 'citation': 'Philippsen TJ, Christensen LS, Hansen MG, Dahl JS, Brandes A. Detection of Subclinical Atrial Fibrillation in High-Risk Patients Using an Insertable Cardiac Monitor. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1557-1564. doi: 10.1016/j.jacep.2017.06.020. Epub 2017 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 65 years\n* arterial hypertension (at least dual treatment)\n* diabetes mellitus (oral antidiabetics or insulin)\n\nExclusion Criteria:\n\n* known atrial fibrillation\n* ischaemic heart disease\n* Current anticoagulation treatment\n* Ejection fraction \\<45 %\n* significant valvular heart disease\n* previous stroke/transient ischemic attack\n* peripheral arterial disease\n* end stage renal disease\n* thyreotoxicosis'}, 'identificationModule': {'nctId': 'NCT02041832', 'briefTitle': 'Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder', 'orgStudyIdInfo': {'id': 'ILR-Afib-study'}, 'secondaryIdInfos': [{'id': 'S-20130062', 'type': 'OTHER', 'domain': 'Videnskabsetisk Komité for Region Syddanmark'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Holter monitoring', 'description': 'Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring', 'interventionNames': ['Other: Conventional Holter monitoring']}, {'type': 'OTHER', 'label': 'Implantable loop recorder', 'description': 'Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder', 'interventionNames': ['Device: Implantable loop recorder']}], 'interventions': [{'name': 'Conventional Holter monitoring', 'type': 'OTHER', 'description': 'Patients undergo 72h Holter monitoring', 'armGroupLabels': ['Holter monitoring']}, {'name': 'Implantable loop recorder', 'type': 'DEVICE', 'otherNames': ['REVEAL XT'], 'description': 'Implantation of loop recorder with follow-up by remote monitoring', 'armGroupLabels': ['Implantable loop recorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6100', 'city': 'Haderslev', 'country': 'Denmark', 'facility': 'Haderslev Hospital', 'geoPoint': {'lat': 55.24943, 'lon': 9.48771}}], 'overallOfficials': [{'name': 'Axel Brandes, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Odense University Hospital/University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axel Brandes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Axel Brandes', 'investigatorAffiliation': 'Odense University Hospital'}}}}