Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-03-02 @ 6:41 PM
Study NCT ID:
NCT02677467
Status:
UNKNOWN
Last Update Posted:
2016-02-09
First Post:
2016-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Epistaxis and Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample for evaluating about cardiovasular risk.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-08', 'studyFirstSubmitDate': '2016-01-31', 'studyFirstSubmitQcDate': '2016-02-08', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholesterol level in each group', 'timeFrame': '1 day'}, {'measure': 'BP variability level in each group', 'timeFrame': '1 day'}, {'measure': 'Pulse wave velocity in each group', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Smoking History in each group', 'timeFrame': '1 day', 'description': 'Example = "12 pack-year"'}, {'measure': 'Body Mass Index in each group', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Disease', 'Epistaxis']}, 'descriptionModule': {'briefSummary': 'Investigators examine blood-pressure variance, several cardiovascular risk factors of patient with epistaxis. As a result of collected data, investigators look into correlation between epistaxis and hypertensive cardiovascular disorder.', 'detailedDescription': 'This study is prospective observational single blinded study.\n\nA participant is visit in the ER who patient with epistaxis.\n\nInvestigators will enroll 50 patients with epistaxis. Exclusion criteria is that patient needs immediately treatment for hypertensive urgency or patient with nasal trauma.\n\nInvestigators examine blood-pressure (BP) at five times in Emergency Department (ED) and out-patient department (opd) of Otorhinolaryngology (OL) . Investigators explain this study and ask to write consent for participant. After proper management of epistaxis, investigators get blood sampling of the participant and, the participant has a reservation to "opd of cardiovascular division of Internal Medicine" (CV opd) in the hospital.\n\nWhen the participant visit CV opd, the participant undergo 24-hours-BP-monitoring and Pulse wave velocity (PWV).\n\nAfter that, the participant will be follow-up for 3 months.\n\nInvestigators collect 50 data from 50 participants as a registry and analyze the data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Group A : A participant enroll if their age is over 18 with spontaneous epistaxis and their cause of visiting ER is spontaneous epistaxis. Exclusion criteria is that they needs immediately treatment for hypertensive urgency. And, they don't want to participate in this investigation.\n\nGroup B : A participant enroll if their age is over 18 with bleeding of wound and their cause of visiting ER is to bleed on wound. Exclusion criteria is that their wounds' condition is serious or their pain is much severe. And, they don't want to participate in this investigation.", 'healthyVolunteers': True, 'eligibilityCriteria': "Group A\n\nInclusion Criteria:\n\n* age is over 18 with spontaneous epistaxis\n\nExclusion Criteria:\n\n* they needs immediately treatment for hypertensive urgency.\n* they don't want to participate in this investigation.\n\nGroup B\n\nInclusion Criteria:\n\n* age is over 18 with bleeding of wound\n\nExclusion Criteria:\n\n* their wounds' condition is serious or their pain is much severe.\n* they don't want to participate in this investigation."}, 'identificationModule': {'nctId': 'NCT02677467', 'acronym': 'CBECD', 'briefTitle': 'Correlation Between Epistaxis and Cardiovascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University'}, 'officialTitle': 'Epistaxis Correlate With Cardiovascular Disease?', 'orgStudyIdInfo': {'id': 'Gurivengers'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spontaneous epistaxis', 'description': "A participant enroll if their age is over 18 with spontaneous epistaxis and their cause of visiting ER is spontaneous epistaxis. Exclusion criteria is that they needs immediately treatment for hypertensive urgency. And, they don't want to participate in this investigation. Investigators examine their blood-pressure variability and cardiovascular risk throughout their blood sample analysis.", 'interventionNames': ['Biological: Blood-pressure variability']}, {'label': 'Bleeding of wound', 'description': "A participant enroll if their age is over 18 with bleeding of wound and their cause of visiting ER is to bleed on wound. Exclusion criteria is that their wounds' condition is serious or their pain is much severe. And, they don't want to participate in this investigation. Investigators examine their blood-pressure variability and cardiovascular risk throughout their blood sample analysis.", 'interventionNames': ['Biological: Blood-pressure variability']}], 'interventions': [{'name': 'Blood-pressure variability', 'type': 'BIOLOGICAL', 'description': 'Day to Night Blood pressure variability', 'armGroupLabels': ['Bleeding of wound', 'Spontaneous epistaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471-701', 'city': 'Guri-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'contacts': [{'name': 'YOONJE LEE, M.D.', 'role': 'CONTACT', 'email': 'yong0831@naver.com', 'phone': '+82-31-560-2053'}, {'name': 'YOONJE LEE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hanyang University Guri Hospital', 'geoPoint': {'lat': 37.5986, 'lon': 127.1394}}], 'centralContacts': [{'name': 'YOONJE LEE, M.D.', 'role': 'CONTACT', 'email': 'yong0831@naver.com', 'phone': '+82-31_560-2053'}, {'name': 'CHANGSUN KIM, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'flyes98@naver.com', 'phone': '+82-31-560-2057'}], 'overallOfficials': [{'name': 'JUNGHOON SHIN, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hanyang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The investigators make a registry for individual participant data and collect the registry and share it.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellowship, Emergency Medincine', 'investigatorFullName': 'LEE YOON-JE', 'investigatorAffiliation': 'Hanyang University'}}}}