Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-02-19 @ 4:43 AM
Study NCT ID:
NCT02534532
Status:
WITHDRAWN
Last Update Posted:
2015-11-25
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation Screening With a Smartphone Device and iECG Application
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-24', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2015-08-26', 'lastUpdatePostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients screened in whom the screening device detect an abnormal cardiac rhythm', 'timeFrame': 'Up to 6 months'}, {'measure': 'Number of patients screened in whom Atrial Fibrillation (AF) was confirmed with ECG', 'timeFrame': 'Up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Number of patients in whom abnormal cardiac rhythm was detected with screening device and AF was confirmed with ECG', 'timeFrame': 'Up to 6 months', 'description': 'Predictive value tests - Positive: Number of patients screened in whom AF was confirmed with ECG/ Number of patients screened in whom the screening device detect an abnormal rhythm - Negative: Number of patients screened in whom AF was discarded with ECG/ Number of patients screened in whom the screening device detect an abnormal rhythm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial fibrillation screening'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Question: Can atrial fibrillation (AF) cases in patients ≥ 65 years be easily detected in a primary healthcare environment using a smartphone device and iECG application as an opportunistic screening tool?\n\nObjectives:\n\nDetection of AF through cardiac rhythm abnormalities in patients ≥65 years old in an opportunistic screening program using a smartphone device/application\n\n1. Define the predictable value of the smartphone device with electrocardiogram (ECG) confirmation to detect AF in patients 65 years and older\n2. Correlate screened patients cardiovascular risk profile and those that register cardiac rhythm irregularities for a better description of the general characteristics of Colombian population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects included in the study are patients 65 years and older reaching programmed primary care counselling, and who are willingly to participate and do not present any exclusion criteria for the screening', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females and males patients ≥65 years old attending primary care counselling\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients with confirmed diagnosis of AF\n* Patients who do not want to participate\n* Patients consulting for acute conditions\n* Patients presenting any diagnosed arrhythmia different than AF'}, 'identificationModule': {'nctId': 'NCT02534532', 'acronym': 'AFScreenCol', 'briefTitle': 'Atrial Fibrillation Screening With a Smartphone Device and iECG Application', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Atrial Fibrillation Screening With a Smartphone Device and iECG Application', 'orgStudyIdInfo': {'id': '18250'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Females and males ≥65 years old, attending to the primary care centers, located in three different major cities in Colombia, that are willing to participate in the study, and do not present any exclusion criteria', 'interventionNames': ['Other: AF screening']}], 'interventions': [{'name': 'AF screening', 'type': 'OTHER', 'description': 'Screening of AF in an opportunistic screening program using a smartphone device/application confirmed by ECG', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}