Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-01 @ 1:46 PM
Study NCT ID:
NCT01759433
Status:
COMPLETED
Last Update Posted:
2013-12-31
First Post:
2012-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reference Intervals for Sonoclot Analysis in Chinese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': '2.7 mL citrated blood.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-28', 'studyFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2012-12-30', 'lastUpdatePostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The reference intervals for sonoclot analysis in Chinese', 'timeFrame': '3 month', 'description': 'whether Chinese reference intervals are different from Caucasian reference intervals.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The reference intervals for Sonoclot Analysis may be different between Chinese and American. So far, no reference interval has been established in Chinese for Sonoclot Analysis. This study is going to establish the first Chinese reference intervals for Sonoclot Analysis and test whether they are different from American reference intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese healthy adults aged 18 and older', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 and older\n* Han ethnic\n\nExclusion Criteria:\n\n* Renal dysfunction\n* Liver disorders\n* Known coagulation disorders\n* Patients taking medications in the last month'}, 'identificationModule': {'nctId': 'NCT01759433', 'briefTitle': 'Reference Intervals for Sonoclot Analysis in Chinese', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Asia Heart Hospital'}, 'officialTitle': 'Reference Ranges for Sonoclot Analysis in Chinese', 'orgStudyIdInfo': {'id': 'SCWH001'}}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Asia Heart hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan Asia Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the clinical laboratory', 'investigatorFullName': 'Zhenlu Zhang', 'investigatorAffiliation': 'Wuhan Asia Heart Hospital'}}}}