Viewing Study NCT00248807



Ignite Creation Date: 2024-05-05 @ 12:06 PM
Last Modification Date: 2024-10-26 @ 9:20 AM
Study NCT ID: NCT00248807
Status: COMPLETED
Last Update Posted: 2014-06-23
First Post: 2005-11-02

Brief Title: A Study of Blood Pressure and Blood Supply to the Brain in Persons With a Spinal Cord Injury
Sponsor: US Department of Veterans Affairs
Organization: VA Office of Research and Development

Study Overview

Official Title: Systemic Hemodynamics and Cerebral Blood Flow in Persons With Tetraplegia
Status: COMPLETED
Status Verified Date: 2014-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
00517 OTHER JJP VAMC IRB None