NCT00175773

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

5.1 years

First QC Date

September 13, 2005

Last Update Submit

September 27, 2019

Conditions

Keywords

Orthostatic stress

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Andrei Krassioukov, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

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

Locations