Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-21 @ 1:33 AM
Study NCT ID:
NCT02016768
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2013-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decompressive Cervical Surgery and Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013117', 'term': 'Spinal Cord Compression'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-09', 'studyFirstSubmitDate': '2013-12-15', 'studyFirstSubmitQcDate': '2013-12-15', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the systolic blood pressure(SBP) measured by 24-hour Ambulatory Blood Pressure Monitoring(ABPM) on 1st month and 3th month post-operation.', 'timeFrame': 'twice ABPM prior to operation and 1st month, 3th month post-operation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Myelopathy, Compressive', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '26738624', 'type': 'DERIVED', 'citation': 'Liu H, Wang HB, Wu L, Wang SJ, Yang ZC, Ma RY, Reilly KH, Yan XY, Ji P, Wu YF. Effects of decompressive cervical surgery on blood pressure in cervical spondylosis patients with hypertension: a time series cohort study. BMC Surg. 2016 Jan 6;16:2. doi: 10.1186/s12893-015-0117-y.'}]}, 'descriptionModule': {'briefSummary': 'There is a relationship between CSM and hypertension, probably a cause/effect relationship, and investigators term this type of hypertension "cervicogenic hypertension". Abnormally functioning serotonergic pacemaker cells in the dorsal raphe nucleus inappropriately activate and inhibit parts of the central and autonomic nervous systems as part of a chronic stress response, which causes hypertension and migraine. This theory is now being expanded to encompass both CSM and essential hypertension, the idea being that these two conditions are intimately related.', 'detailedDescription': 'Cervical spondylotic myelopathy (CSM) and hypertension are both very common diseases in the general population.Investigators have also observed previously hypertensive patients with CSM become normotensive following decompressive cervical surgery and no longer need antihypertensive medications. Both observations are difficult to explain according to current theories of the two diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at our Spine Center suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with hypertension.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established diagnosis of cervical spondylosis myelopathy\n* Be at least 18 years of age\n* Office-measured systolic BP≧140mmHg\n* Ability to adhere to study protocol\n* Have signed an approved informed consent form for participation in this study\n\nExclusion Criteria:\n\n* Have hypertension secondary to a treatable cause\n* Have prior cervical spine surgery\n* Are pregnant or contemplating pregnancy during the 3-month follow-up period\n* People deny to join the study\n* Are unable to comply with protocol requirements\n* Are unlikely to survive the protocol follow-up period\n* Are enrolled in another concurrent clinical trial\n* Visual Analogue Scale≥4'}, 'identificationModule': {'nctId': 'NCT02016768', 'briefTitle': 'Decompressive Cervical Surgery and Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Decompressive Cervical Surgery for Antihypertensive Effect in Patients With Cervical Spondylosis and Hypertension-A Cohort Study', 'orgStudyIdInfo': {'id': 'PUCRP201304'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'operation', 'description': 'To make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension.', 'interventionNames': ['Procedure: decompressive cervical surgery']}], 'interventions': [{'name': 'decompressive cervical surgery', 'type': 'PROCEDURE', 'otherNames': ['anterior cervical discectomy fusion', 'posterior laminoplasty'], 'description': 'To make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension.', 'armGroupLabels': ['operation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100433', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Hong LIu', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Hong Liu, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Unversity First Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Hong Liu', 'investigatorAffiliation': 'Peking University First Hospital'}}}}