Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-27 @ 4:14 AM
Study NCT ID:
NCT02062957
Status:
UNKNOWN
Last Update Posted:
2014-02-25
First Post:
2014-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endovascular Function in Atrial Fibrillation (AF) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-23', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endovascular function results', 'timeFrame': 'Up to 24 weeks.', 'description': 'The method to assess the endovascular function is PAT. The index is Reactive hyperemia index (RHI). RHI between patients and control will be compared.'}], 'secondaryOutcomes': [{'measure': 'predictive effect of endovascular function on recurrence of AF', 'timeFrame': 'Up to 1 year', 'description': 'We will do the multi-logistic analysis of the recurrence of AF.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['PAT Result']}, 'descriptionModule': {'briefSummary': '1. recruit 50 patients with atrial fibrillation and 30 controls\n2. endovascular function assessment with Peripheral Arterial Tonometry (PAT)\n3. follow up the occurence of AF'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with AF', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or\n* electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or\n* electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration \\>1 year).\n\nExclusion Criteria:\n\n* patients with cerebralvascular disease\n* patients with coronary disease\n* patients with peripheric artery disease'}, 'identificationModule': {'nctId': 'NCT02062957', 'acronym': 'HEAF', 'briefTitle': 'Endovascular Function in Atrial Fibrillation (AF) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Endovascular Function in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'NF81300148'}}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Han, Bachelor', 'role': 'CONTACT', 'phone': '86-10185231512'}, {'name': 'Guangzhen Zhong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Chaoyang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Guangzhen Zhong', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}