Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-25 @ 10:53 PM
Study NCT ID:
NCT03396133
Status:
UNKNOWN
Last Update Posted:
2020-07-28
First Post:
2017-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Snap on Symptomatic Arrhythmia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2017-12-07', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia', 'timeFrame': '3-month', 'description': 'Participants in Snap group acquired ECG once od according to the rules and transmitted ECG immediately once symptom appeared between 3-month. Patients in the routine treatment (RT) group were administrated normal diagnostic techniques. At 3-month, compared the incidence atrial arrhythmia(atrial premature beats and atrial tachycardia) and ventricula arrhythmia(ventricular premature beats and ventricular tachycardia) between two groups.'}], 'secondaryOutcomes': [{'measure': "Evaluating the patients' quality of life", 'timeFrame': '3-month', 'description': "Using RAND 36-Item Short Form Health Survey (SF-36) 1.0 Questionnaire items assessed the quality of life of participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.\n\nThe eight sections are: vitality, physical functioning, bodily pain, general, health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The total scale ranges from 35 to 145. The higher the total score, the better the patient's quality of life."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Snap', 'symptomatic arrhythmia', 'diagnosis', 'follow-up'], 'conditions': ['Arrhythmia']}, 'referencesModule': {'references': [{'pmid': '28851729', 'type': 'RESULT', 'citation': 'Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C, Gravenor MB. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. 2017 Nov 7;136(19):1784-1794. doi: 10.1161/CIRCULATIONAHA.117.030583. Epub 2017 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'Participants in the Snap arm were instructed to undertake once-day recording and transmission of a 30-second single-lead iECG trace to a secure server, plus additional submissions if symptomatic over a 3-month period. Snap traces were analyzed by an automated analysis software and cardiologists. Clinical review and appropriate care was arranged for those clinically significant arrhythmia. Patients in the RC group were followed up as normal methods including ECG, Holter.', 'detailedDescription': 'Individuals with symptomatic arrhythmia without known arrhythmia were recruited.\n\nParticipants were required to have access to the internet via WiFi and to be able to operate the Snap system after simple instruction. Written consent was obtained, and eligible participants were randomized (1:1) to an intervention (Snap) group or RC group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic arrhythmia\n\nExclusion Criteria:\n\n* can not use the Snap instrument and Sign informed consent'}, 'identificationModule': {'nctId': 'NCT03396133', 'briefTitle': 'Efficacy of Snap on Symptomatic Arrhythmia', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Assessment of Portable Remote Health Monitor Using the Snap to Symptomatic Arrhythmia', 'orgStudyIdInfo': {'id': '009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Snap group', 'description': 'individuals in this arm used Snap according to the instruction on time and screened at the symptomatic', 'interventionNames': ['Diagnostic Test: Snap']}, {'type': 'NO_INTERVENTION', 'label': 'RC group', 'description': 'patients in the RC arm accepted normal methods'}], 'interventions': [{'name': 'Snap', 'type': 'DIAGNOSTIC_TEST', 'description': 'screen, transmission, and analysis ECG automated', 'armGroupLabels': ['Snap group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin-Shuang Li, MD', 'role': 'CONTACT', 'email': 'gd_l2000@163.com', 'phone': '18751070788', 'phoneExt': '86'}], 'facility': 'Dyno', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin-Shuang Li, MD', 'role': 'CONTACT', 'email': 'gd_l2000@163.com', 'phone': '18751070788'}], 'facility': 'the First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Chun-Jian Li, PHD', 'role': 'CONTACT', 'email': 'lijay@njmu.edu.cn', 'phone': '13701465229', 'phoneExt': '86'}, {'name': 'Jin-Shuang Li, MD', 'role': 'CONTACT', 'email': 'gd_l2000@163.com', 'phone': '13773998967', 'phoneExt': '86'}], 'overallOfficials': [{'name': 'Chun-Jian Li, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}, {'name': 'Jin-Shuang Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Suqian People's Hospital of Nanjing Drum Tower Hospital Group"}, {'name': 'Liang-Hong Ying, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Chunjian Li', 'investigatorAffiliation': 'The First Affiliated Hospital with Nanjing Medical University'}}}}