Clinical Trials Directory

Trials / Completed

CompletedNCT00248807

A Study of Blood Pressure and Blood Supply to the Brain in Persons With a Spinal Cord Injury.

Systemic Hemodynamics and Cerebral Blood Flow in Persons With Tetraplegia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUG1.25 mg enalaprilat IVan angiotensin converting enzyme (ACE) inhibitor given to lower blood pressure (BP) and measure cerebral blood flow (CBF)
OTHERHead up tilt (HUT)45 degree head-up tilt to lower blood pressure and measure cerebral blood flow.

Timeline

Start date
2005-10-01
Primary completion
2009-05-01
Completion
2012-04-01
First posted
2005-11-04
Last updated
2025-02-25
Results posted
2014-06-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00248807. Inclusion in this directory is not an endorsement.