Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 4:17 PM
Study NCT ID:
NCT01170559
Status:
COMPLETED
Last Update Posted:
2023-01-05
First Post:
2010-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Loop Recorders for Diagnosis of Palpitations in A&E
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2010-07-26', 'lastUpdatePostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of the study is the proportion of patients achieving a definite diagnosis in each of the two groups at the end of one year', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'The time taken from randomisation in the A&E to making the diagnosis (if any) in each group', 'timeFrame': '1 Year'}, {'measure': 'The cost of achieving a diagnosis in each group', 'timeFrame': '1 Year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Palpitations']}, 'descriptionModule': {'briefSummary': "Heart rhythm abnormalities underlie one of the common presenting complaints to the A\\&E and out-patient departments, specifically awareness of heart beats or palpitations. Unless an ECG (electrocardiogram) tracing of the heart rhythm can be recorded while the patient is having symptoms, it is very difficult to determine the cause of the palpitations. The conventional approach is to refer these patients from the emergency departments to the Cardiology outpatients where they undergo repeated short term rhythm monitoring hoping to record the rhythm underlying the patient's complaint. Unfortunately, this often yields no results thus delaying definitive treatment and incurring extra costs of repeated investigations and A\\&E presentations. This study aims to compare the ability of the conventional approach to establish a definite diagnosis compared to that of an early invasive monitoring approach with a small implantable device that records the heart rhythm at all time for up to 18 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Good history of episodic symptomatic sustained palpitations (sudden onset and offset, fast heart beats, may be associated with shortness of breath or dizziness)\n* Terminates before presentation to hospital\n* Episodes occur at a frequency of less than once every two weeks\n* Never previously caught on ECG or ambulatory monitoring\n* Normal resting ECG\n\nExclusion Criteria:\n\n* Contraindication to ILR implantation i.e. ongoing oral anticoagulation with INR \\>1.6, ongoing infection, sepsis or fever, etc.\n* Palpitations suggestive of extrasystoles (single missed or dropped beats)\n* Known or suspected severe valvular or myocardial heart disease\n\n * An audible heart murmur\n * Any abnormality on the surface ECG\n* Thyrotoxicosis\n* Patients who refuse an ILR when offered will not be included in either limb of the study'}, 'identificationModule': {'nctId': 'NCT01170559', 'acronym': 'LIAISE', 'briefTitle': 'Use of Loop Recorders for Diagnosis of Palpitations in A&E', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'Use of Implantable Loop Recorders as a Primary Investigation of Infrequent Undiagnosed ArrhythmIa Symptoms in the Emergency Department', 'orgStudyIdInfo': {'id': '006628 BLT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: ILR Group', 'description': 'Group allocated to receiving an ILR in the A\\&E department.', 'interventionNames': ['Device: Implantable Loop Recorder']}, {'type': 'NO_INTERVENTION', 'label': 'Group 2: Conventional', 'description': 'Group randomised to conventional lines of investigation'}], 'interventions': [{'name': 'Implantable Loop Recorder', 'type': 'DEVICE', 'otherNames': ['Reveal XT'], 'armGroupLabels': ['Group 1: ILR Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barts and the London NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Richard Schilling, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts and the London NHS Trust, Queen Mary University of London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}