Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-03-06 @ 7:32 AM
Study NCT ID:
NCT02262351
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2014-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-04', 'studyFirstSubmitDate': '2014-09-30', 'studyFirstSubmitQcDate': '2014-10-07', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of screening tests', 'timeFrame': 'Baseline visit', 'description': 'The sensitivity and specificity of SL-ECG and BP-AF will be separately compared with that of pulse palpation alone using McNemar\'s method. This method can be used when only those subjects screening positive attend for confirmatory testing (12-lead ECG ± Holter monitor). A 2-sided alpha of 0.025 will be used to allow for multiple comparisons. A further analysis will be performed using the SL-ECG data as the gold standard. To ensure adequate diagnostic quality, this analysis will only be performed if 5% or less of the overall SL-ECG tracings are deemed "uninterpretable". A bipolar ECG interpreted by a cardiologist has a reported 99% sensitivity and 96% specificity for the diagnosis of AF. If this exploratory analysis is performed it will enable estimation of the sensitivity and specificity of the pulse-check and BP-AF device.'}], 'secondaryOutcomes': [{'measure': 'Cost of each method per case of actionable AF detected', 'timeFrame': '90 days'}, {'measure': 'Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints', 'timeFrame': '90 days'}, {'measure': 'Prescription rates at 90±14 days for oral anticoagulant agents (OACs) and drugs for control of heart rate and/or rhythm for patients with actionable AF', 'timeFrame': '90 days'}, {'measure': 'Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.', 'timeFrame': '90 days'}, {'measure': 'Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).', 'timeFrame': '90 days'}, {'measure': 'Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.', 'timeFrame': '90 days'}, {'measure': 'Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF.', 'timeFrame': '90 days'}, {'measure': 'Time taken for each screening test', 'timeFrame': 'Baseline'}, {'measure': 'Death rate for each case of actionable AFib identified', 'timeFrame': '90 days'}, {'measure': 'Stroke or transient ischemic attack rate for each case of actionable AFib identified', 'timeFrame': '90 days'}, {'measure': 'Systemic embolism rate for each case of actionable AFib identified', 'timeFrame': '90 days'}, {'measure': 'Myocardial infarction rate rate for each case of actionable AFib identified', 'timeFrame': '90 days'}, {'measure': 'Significant bleeding rate for each case of actionable AFib identified', 'timeFrame': '90 days'}, {'measure': 'Hospitalization due to heart failure rate for each case of actionable AFib identified', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Screening', 'Family Practice', 'Novel screening technologies'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '30072410', 'type': 'RESULT', 'citation': 'Quinn FR, Gladstone DJ, Ivers NM, Sandhu RK, Dolovich L, Ling A, Nakamya J, Ramasundarahettige C, Frydrych PA, Henein S, Ng K, Congdon V, Birtwhistle RV, Ward R, Healey JS. Diagnostic accuracy and yield of screening tests for atrial fibrillation in the family practice setting: a multicentre cohort study. CMAJ Open. 2018 Aug 2;6(3):E308-E315. doi: 10.9778/cmajo.20180001. Print 2018 Jul-Sep.'}, {'pmid': '30144961', 'type': 'RESULT', 'citation': 'Tarride JE, Quinn FR, Blackhouse G, Sandhu RK, Burke N, Gladstone DJ, Ivers NM, Dolovich L, Thornton A, Nakamya J, Ramasundarahettige C, Frydrych PA, Henein S, Ng K, Congdon V, Birtwhistle RV, Ward R, Healey JS. Is Screening for Atrial Fibrillation in Canadian Family Practices Cost-Effective in Patients 65 Years and Older? Can J Cardiol. 2018 Nov;34(11):1522-1525. doi: 10.1016/j.cjca.2018.05.016. Epub 2018 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment of AF is one of the best way to prevent stroke. The problem is that because AF may cause minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is known that as many as half of all patients with known AF may not be receiving appropriate anticoagulation for their condition. New technologies are making it possible to improve AF detection. Subjects in this study will be screened for AF using three simple methods: a 30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood pressure monitor with built-in AF screening capabilities. If more patients with AF can be detected, more patients will be able to receive guideline-recommended anticoagulant therapy, and more strokes, deaths, disability, and dementia will be prevented.', 'detailedDescription': 'Participants will be screened for AF using three simple methods (pulse check, single-lead ECG, blood pressure machine with automated AF detection algorithms). Subjects screening positive on any test will attend for a 12-lead ECG within 24 h. For all patients with AF detected, clinical characteristics and medications will be compared at baseline and 90±14 days later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥65 years.\n2. Attending their usual Primary Care Clinic.\n3. Provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients considered by the Investigator to be unsuitable for study follow-up because the patient:\n\n 1. is unreliable concerning the follow-up schedule\n 2. cannot be contacted by telephone\n 3. has a life expectancy less than the anticipated study duration due to concomitant disease.\n2. Presence of an implanted pacemaker or defibrillator.\n3. Inability to have a BP cuff applied.\n4. Documented significant allergy to ECG electrode adhesive.\n5. Previously screened as part of this study.'}, 'identificationModule': {'nctId': 'NCT02262351', 'acronym': 'PIAAF-FP', 'briefTitle': 'Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting', 'orgStudyIdInfo': {'id': 'PIAAF-FP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening', 'description': 'Subjects will undergo three screening methods for atrial fibrillation:\n\n30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device', 'interventionNames': ['Other: 30 Second Pulse Check', 'Device: Watch BP Home A', 'Device: HeartCheck Hand-held ECG device']}], 'interventions': [{'name': '30 Second Pulse Check', 'type': 'OTHER', 'description': 'To detect atrial fibrillation', 'armGroupLabels': ['Screening']}, {'name': 'Watch BP Home A', 'type': 'DEVICE', 'description': 'Blood pressure device that detects atrial fibrillation', 'armGroupLabels': ['Screening']}, {'name': 'HeartCheck Hand-held ECG device', 'type': 'DEVICE', 'description': 'To detect atrial fibrillation', 'armGroupLabels': ['Screening']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Black Diamond', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Family Medical Centre', 'geoPoint': {'lat': 50.68771, 'lon': -114.23241}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Crowfoot Village Family Practice', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Camrose', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Smith Clinic, Camrose PCN', 'geoPoint': {'lat': 53.01684, 'lon': -112.83525}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Abbottsfield Medical Centre', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Alta Clinical Research', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Edmonton Oliver PCN', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Olds', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Peaks to Prairies PCN', 'geoPoint': {'lat': 51.78341, 'lon': -114.10199}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Medical Clinic', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's Family Health Team", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'city': 'Kirkfield', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kirkfield Medical Centre', 'geoPoint': {'lat': 44.56682, 'lon': -78.98289}}, {'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ken Ng Family Practice / Total Health Management', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SKDS Research Inc', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'city': 'Owen Sound', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Mark Robertson Family Practice', 'geoPoint': {'lat': 44.56717, 'lon': -80.94349}}, {'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Port Arthur Clinic Research Program', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Dennis Weston Health Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Village Health Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Women's College Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sameh Fikry Medicine Professional Corporation', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'F. Russell Quinn, MRCP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}