- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02016768
Decompressive Cervical Surgery and Hypertension
January 9, 2020 updated by: Hong Liu, Peking University First Hospital
Decompressive Cervical Surgery for Antihypertensive Effect in Patients With Cervical Spondylosis and Hypertension-A Cohort Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100433
- Hong LIu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 84 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients at our Spine Center suffering signs and symptoms of cervical myelopathy and with evidence of radiographic cervical cord compression with hypertension.
Description
Inclusion Criteria:
- Established diagnosis of cervical spondylosis myelopathy
- Be at least 18 years of age
- Office-measured systolic BP≧140mmHg
- Ability to adhere to study protocol
- Have signed an approved informed consent form for participation in this study
Exclusion Criteria:
- Have hypertension secondary to a treatable cause
- Have prior cervical spine surgery
- Are pregnant or contemplating pregnancy during the 3-month follow-up period
- People deny to join the study
- Are unable to comply with protocol requirements
- Are unlikely to survive the protocol follow-up period
- Are enrolled in another concurrent clinical trial
- Visual Analogue Scale≥4
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
operation
To make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension.
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To make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: twice ABPM prior to operation and 1st month, 3th month post-operation.
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twice ABPM prior to operation and 1st month, 3th month post-operation.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hong Liu, Master, Peking Unversity First Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2014
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
December 15, 2013
First Submitted That Met QC Criteria
December 15, 2013
First Posted (ESTIMATE)
December 20, 2013
Study Record Updates
Last Update Posted (ACTUAL)
January 13, 2020
Last Update Submitted That Met QC Criteria
January 9, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUCRP201304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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