Spinal Cord Injuries Clinical Trial
Official title:
Systemic Hemodynamics and Cerebral Blood Flow in Persons With Tetraplegia
Verified date | May 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this study is to determine how blood pressure and blood flow are controlled during head-up tilt in a semi-upright position. In this investigation we are studying blood pressure and blood flow to the brain, with and without a medication which lowers blood pressure (Vasotec). We will determine how persons with a spinal cord injury are able to maintain blood flow to the brain (not get dizzy) as they assume a more upright position and their blood pressure decreases.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2012 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Duration of spinal cord injury (SCI) at least 1 year - Level of SCI C4-8 and T6 and below - matched non-SCI subjects - Chronological age between 18-65 years - Euhydration: Subjects will be instructed to avoid caffeine and alcohol and to maintain normal salt and water intake for several days prior to study. Exclusion Criteria: - Known heart and/or blood vessel disease - Dehydration - High blood pressure - Kidney disease - Diabetes mellitus - Prescribed ACE inhibitors - Acute Infection - Smoking - Pregnancy |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center, Bronx | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Handrakis JP, DeMeersman RE, Rosado-Rivera D, LaFountaine MF, Spungen AM, Bauman WA, Wecht JM. Effect of hypotensive challenge on systemic hemodynamics and cerebral blood flow in persons with tetraplegia. Clin Auton Res. 2009 Feb;19(1):39-45. doi: 10.1007 — View Citation
Wecht JM, Rosado-Rivera D, Jegede A, Cirnigliaro CM, Jensen MA, Kirshblum S, Bauman WA. Systemic and cerebral hemodynamics during cognitive testing. Clin Auton Res. 2012 Feb;22(1):25-33. doi: 10.1007/s10286-011-0139-1. Epub 2011 Jul 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic Blood Pressure | Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention | acute testing | No |
Secondary | Cerebral Blood Flow | Measurement of middle cerebral artery blood flow velocity supine and during head-up tilt | acute testing | No |
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