Mechanisms of Orthostatic Intolerance in Spinal Cord Injured Individuals and Following Bed Rest
1 other identifier
observational
51
1 country
1
Brief Summary
The primary purpose of this study is to investigate the relationship between the extent of neurologic (nerve) impairment in patients with spinal cord injuries and how well the nerves passing down the spine to the heart and blood vessels are working. These nerves are called the descending spinal sympathetic pathway (DSSP) and are important in controlling many functions, including blood pressure. We also wish to examine how injury severity and DSSP function influence blood levels of nor-epinephrine and epinephrine. Nor-epinephrine and epinephrine are hormones released into the blood that are also important in controlling blood pressure. Thus, we will also look at how the effect of the extent of DSSP dysfunction influences heart rate and blood pressure and blood levels of certain enzymes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2004
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 1, 2019
September 1, 2019
5.1 years
September 13, 2005
September 27, 2019
Conditions
Keywords
Eligibility Criteria
SCI individuals (19 to 55 years of age) with a functionally complete or a functionally incomplete spinal cord injury will constitute the study population.
You may qualify if:
- \. SCI individuals (19 to 55 years of age) with a functionally complete or a functionally incomplete spinal cord injury will constitute the study population. These groups will be subdivided according to whether the SCI is acute or chronic. 2. Neurologically intact, age-matched control individuals who are confined to bedrest for 5-7 days as the result of a musculoskeletal condition (eg. following a pelvic/acetabular fracture) or lumbar drain will also be recruited. 3. Healthy able bodied control volunteer subjects.
You may not qualify if:
- Subjects under 19 and over 55 years of age; subjects with symptomatic cardiovascular disease or problems, any unstable medical/psychiatric condition or substance abuse that is likely to affect their ability to complete the study. Individuals with SCI and active medical issues such as pressure sores, urinary tract infections, hypertension or heart disorders will be excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital, Echeleon Bldg.
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrei Krassioukov, MD
University of British Columbia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
November 1, 2004
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
October 1, 2019
Record last verified: 2019-09