Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-24 @ 9:22 AM
Study NCT ID:
NCT02109120
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2014-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MMP-9 Monitoring Particulate Cerebral Embolisation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum,Freeze-saving -80℃'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-08', 'studyFirstSubmitDate': '2014-04-07', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative ischemic stroke', 'timeFrame': '7 days after surgery'}], 'secondaryOutcomes': [{'measure': 'postoperative elevation of plasma MMP9', 'timeFrame': 'perioperative phage'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cerebral Embolic Damage']}, 'referencesModule': {'references': [{'pmid': '15015192', 'type': 'RESULT', 'citation': 'Molloy KJ, Thompson MM, Schwalbe EC, Bell PR, Naylor AR, Loftus IM. Elevation in plasma MMP-9 following carotid endarterectomy is associated with particulate cerebral embolisation. Eur J Vasc Endovasc Surg. 2004 Apr;27(4):409-13. doi: 10.1016/j.ejvs.2004.02.001.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed?term=Elevation+in+plasma+MMP-9+following+carotid+endarterectomy+is+associated+with+particulate+cerebral+embolisation&TransSchema=title&cmd=detailssearch', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '1. In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9 concentration cross CEA will be identified.\n2. And the part of patients suffered particulate cerebral embolic injury, their MMP9 level will increase in the early stage after CEA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients under CEA in the PUMCH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-All patients enrolled had at least ≥70% unilateral or bilateral stenosis of Internal -Carotid Artery， or those who had a \\<70% stenosis but obvious cerebral ischema symptoms had been existed.\n\nExclusion Criteria:\n\n* Exclusion criteria included poor temporal window\n* Refused to cooperate with us\n* Nonatheromatous such as takayasu arteritis and fibromuscular dysplasia.'}, 'identificationModule': {'nctId': 'NCT02109120', 'acronym': 'MMP9MPCE', 'briefTitle': 'MMP-9 Monitoring Particulate Cerebral Embolisation', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Dynamic Changes of MMP9 Concentration Cross Carotid Endarterectomy Monitoring Particulate Cerebral Embolisation', 'orgStudyIdInfo': {'id': 'PUMCH-0321'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'carotid endarterectomy (CEA)', 'description': 'CEA patients with vein blood collection', 'interventionNames': ['Procedure: vein blood collection']}], 'interventions': [{'name': 'vein blood collection', 'type': 'PROCEDURE', 'description': '5 ml peripheral vein blood samples were collected from each patient admitted to our study at the following time-points：Pre-operative（morning of surgery），just before declamping，30mins after declamping and post-operative（12h）.', 'armGroupLabels': ['carotid endarterectomy (CEA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'vascular surgery department of PUMCH', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}