Clinical trial NCT00248807: A Study of Blood Pressure and Blood Supply to the Brain in Persons With a Spinal Cord Injury.
Official title: Systemic Hemodynamics and Cerebral Blood Flow in Persons With Tetraplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthostatic Hypotension
Spinal Cord Injuries
Keywords: Blood Pressure, Low
Hypotension, Postural
Injuries, Spinal Cord
Spinal Cord Transection
Spinal Cord Trauma
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Individuals with tetraplegia lack normal sympathetic nervous system regulation of blood pressure and, therefore, relative hypotension is a common occurrence. This hypotension may be more pronounced with postural stress. Loss in mental acuity and sometimes even consciousness is an associated symptom of postural hypotension in individuals with tetraplegia.

There is some evidence to suggest that although mean arterial blood pressure (MAP) is relatively low in these individuals, middle cerebral arterial blood flow (CBF) may be maintained. Consequently, individuals with chronic tetraplegia often compensate and are stable in the seated upright position.

Autoregulation of CBF has been defined as the stability of cerebral blood flow throughout a range of systemic blood pressures (MAP). This proposal will examine systemic hemodynamics and middle cerebral artery blood flow during HUT with and without Vasotec, an angiotensin II inhibitor. By partially or completely ablating the renin-angiotensin system, which is postulated to play a major role in blood pressure regulation, the potential dissociation between systemic blood pressure and middle cerebral artery blood flow, in individuals with tetraplegia, may be demonstrated. The aim is to determine whether persons with chronic tetraplegia are able to maintain similar CBF, or similar CBF changes, as able-bodied controls despite a greater decrease in MAP to the same hypotensive challenge. The relationship between MAP and CBF has not been defined in this population. Understanding this relationship may lead to improved screening and treatment for prevention of postural hypotension in persons with tetraplegia.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: acute testing
Secondary outcomes:
measure: Cerebral Blood Flow
timeFrame: acute testing
Other outcomes:
Locations:
city: Bronx
country: United States
facility: VA Medical Center, Bronx
state: New York
Study officials:
affiliation: VA Medical Center, Bronx
name: Jill Wecht, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/s10286-008-0496-6. Epub 2008 Oct 11.