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Decompressive Cervical Surgery and Hypertension

This study is currently recruiting participants.
Verified September 2016 by Hong Liu, Peking University First Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02016768
First Posted: December 20, 2013
Last Update Posted: October 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Peking University
Information provided by (Responsible Party):
Hong Liu, Peking University First Hospital
  Purpose
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.

Condition Intervention
Myelopathy, Compressive Hypertension Procedure: decompressive cervical surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decompressive Cervical Surgery for Antihypertensive Effect in Patients With Cervical Spondylosis and Hypertension-A Cohort Study

Further study details as provided by Hong Liu, Peking University First Hospital:

Primary Outcome Measures:
  • 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. ]

Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: decompressive cervical surgery
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:
  • anterior cervical discectomy fusion
  • posterior laminoplasty

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016768


Contacts
Contact: Shijun Wang, Doctor 86-10-83572642 doctorwang444@aliyun.com
Contact: Lei Yue, Bachlor 86-18217022500 yueleimail@foxmail.com

Locations
China, Beijing
Hong LIu Recruiting
Beijing, Beijing, China, 100433
Contact: Shijun Wang, Doctor    86-01083572642    doctorwang444@aliyun.com   
Contact: Lei Yue, Bachlor    86-18217022500    yueleimail@foxmail.com   
Sponsors and Collaborators
Peking University First Hospital
Peking University
Investigators
Principal Investigator: Hong Liu, Master Peking Unversity First Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hong Liu, Dr., Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02016768     History of Changes
Other Study ID Numbers: PUCRP201304
First Submitted: December 15, 2013
First Posted: December 20, 2013
Last Update Posted: October 3, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Hypertension
Spinal Cord Diseases
Spinal Cord Compression
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries