Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT01867060
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2013-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-24', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-05-31', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect all episodes of paroxysmal atrial fibrillation.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'The diagnostic yield of a Personal Heart Rhythm Monitor (PHRM), used for 3 months, compared to an automated cardiac event recorder (ACER), used for 1 week, to detect prolonged episodes of paroxysmal atrial fibrillation (defined as greater than 12 hours).', 'timeFrame': '18 months'}, {'measure': 'The sensitivity and specificity of serum biomarkers to detect cases of PAF.', 'timeFrame': '18 months'}, {'measure': 'The sensitivity and specificity of markers of left atrial function to predict PAF.', 'timeFrame': '18 months'}, {'measure': 'The development of AF in a cohort confirmed to have frequent atrial ectopic beats (APBs) over a one year period.', 'timeFrame': '18 months'}, {'measure': 'Adverse events (including stroke/TIA, myocardial infarction, significant bleeding events and death) at six and twelve month intervals.', 'timeFrame': '30 months'}, {'measure': 'Stroke reduction in the local area', 'timeFrame': '30 months', 'description': 'A reduction in stroke burden in the local area will be calculated from estimated stroke risk in individuals identified with AF and from a local registry.'}, {'measure': 'Referrals to secondary care for suspected AF/palpitations', 'timeFrame': '18 months', 'description': 'The number of referrals to secondary care for suspected PAF will be analysed.'}, {'measure': 'Participant satisfaction with the devices used in the study.', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac monitoring', 'Biomarkers', 'Transthoracic echocardiography'], 'conditions': ['Paroxysmal Atrial Fibrillation', 'Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.haste.uk.com', 'label': 'HASTE charity website'}]}, 'descriptionModule': {'briefSummary': 'This propsective study aims to compare the diagnostic yield of a Personal Heart Rhythm Monitor (PHRM) with an automated cardiac event recorder (ACER) to detect paroxysmal Atrial Fibrillation PAF). The investigators hypothesise that the PHRM, used intermittently for 3 months, will detect significantly more cases of PAF than the ACER, used continuously for one week.\n\nA case-control sub-study will identify individuals with confirmed PAF, and matched individuals with no evidence of PAF, to identify potential serum biomarkers for PAF.\n\nA further case-control study will assess markers of left atrial function in patients with PAF and their matched controls.\n\nAnother case-control sub-study will determine the significance of frequent Atrial Premature Beats (APBs) in the development of AF over a one year period.', 'detailedDescription': "Patients with suspected AF will be initially referred to a community-based, nurse-led Arrhythmia clinic by their General Practitioners over a 15-month period.\n\nAll patients will be issued with a one week ACER (the 'R. Test 4 Evolution'), seen as the 'best-practice' investigation for this population group. Participants will also be issued with a PHRM for three months. They will be instructed to take regular twice-daily, 30 second recordings with additional recordings in the event of relevant symptoms. They will return the ACER after one week and the PHRM after 3 months.\n\nA subgroup of participants (target recruitment number = 100) will undergo transthoracic echocardiography. A 40ml venous blood sample will also be taken. Another small subgroup (target recruitment = 20) will be asked to continue twice-daily recordings using the PHRM for a further nine months and will be issued with a repeat one week ACER at study completion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected paroxysmal AF (either palpitations consistent with AF or an irregular pulse)\n* 12-lead resting ECG confirming sinus rhythm\n* Capacity to consent to study\n* English-speaking\n* Life expectancy at least one year\n\nExclusion Criteria:\n\n* Previous diagnosis of AF\n* Recent history of syncope\n* Recent history of cardiac-sounding chest pain\n* A resting ECG suggestive of alternative arrhythmia\n* Inability to use the telephone\n* Thyrotoxicosis'}, 'identificationModule': {'nctId': 'NCT01867060', 'briefTitle': 'Using a Personal Heart Rhythm Monitor to Diagnose Paroxsymal Atrial Fibrillation in the Community', 'organization': {'class': 'OTHER', 'fullName': 'University of Surrey'}, 'officialTitle': 'Using a Personal Heart Rhythm Monitor (PHRM) to Diagnose Paroxsymal Atrial Fibrillation (PAF) in the Community; and the PREDICT-PAF Substudy - an Investigation of Biomarkers to Detect PAF.', 'orgStudyIdInfo': {'id': 'HASTE-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Personal Heart Rhythm Monitor', 'description': 'Automated Cardiac Event Recorder in parallel with Personal Heart Rhythm Monitor.', 'interventionNames': ['Device: Automated Cardiac Event Recorder', 'Device: Personal Heart Rhythm Monitor']}], 'interventions': [{'name': 'Automated Cardiac Event Recorder', 'type': 'DEVICE', 'otherNames': ["'R. Test Evolution 4' (Novacor)."], 'description': 'Automated Cardiac Event Recorder to be worn continuously for one week.', 'armGroupLabels': ['Personal Heart Rhythm Monitor']}, {'name': 'Personal Heart Rhythm Monitor', 'type': 'DEVICE', 'otherNames': ["'Portable ECG monitor HCG-801' (OMRON Healthcare)."], 'description': 'Personal Heart Rhythm Monitor to be used twice-daily for three months.', 'armGroupLabels': ['Personal Heart Rhythm Monitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'Philippa Howlett, MBChB BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal Surrey County Hospital'}, {'name': 'Edward Leatham, MBChB MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Royal Surrey County Hospital'}, {'name': 'Chris Fry, BSc PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The University of Surrey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Surrey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Surrey County Hospital NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}