search
Back to results

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

Primary Purpose

Orthostatic Hypotension, Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1.25 mg enalaprilat IV
Head up tilt (HUT)
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Orthostatic Hypotension focused on measuring Blood Pressure, Low, Hypotension, Postural, Injuries, Spinal Cord, Spinal Cord Transection, Spinal Cord Trauma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Medical Center, Bronx

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

ARM 1

ARM 3

ARM 2

ARM 4

Arm Description

Head-up tilt maneuver without drug in subjects with spinal cord injury

Head-up tilt maneuver without drug in able-bodied controls

Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in subjects with spinal cord injury

Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in able-bodied controls.

Outcomes

Primary Outcome Measures

Systolic Blood Pressure
Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention

Secondary Outcome Measures

Cerebral Blood Flow
Measurement of middle cerebral artery blood flow velocity supine and during head-up tilt

Full Information

First Posted
November 2, 2005
Last Updated
May 21, 2014
Sponsor
US Department of Veterans Affairs
search

1. Study Identification

Unique Protocol Identification Number
NCT00248807
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension, Spinal Cord Injuries
Keywords
Blood Pressure, Low, Hypotension, Postural, Injuries, Spinal Cord, Spinal Cord Transection, Spinal Cord Trauma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM 1
Arm Type
Placebo Comparator
Arm Description
Head-up tilt maneuver without drug in subjects with spinal cord injury
Arm Title
ARM 3
Arm Type
Placebo Comparator
Arm Description
Head-up tilt maneuver without drug in able-bodied controls
Arm Title
ARM 2
Arm Type
Active Comparator
Arm Description
Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in subjects with spinal cord injury
Arm Title
ARM 4
Arm Type
Active Comparator
Arm Description
Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in able-bodied controls.
Intervention Type
Drug
Intervention Name(s)
1.25 mg enalaprilat IV
Intervention Description
an angiotensin converting enzyme (ACE) inhibitor given to lower blood pressure (BP) and measure cerebral blood flow (CBF)
Intervention Type
Other
Intervention Name(s)
Head up tilt (HUT)
Intervention Description
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow.
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention
Time Frame
acute testing
Secondary Outcome Measure Information:
Title
Cerebral Blood Flow
Description
Measurement of middle cerebral artery blood flow velocity supine and during head-up tilt
Time Frame
acute testing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Wecht, EdD
Organizational Affiliation
VA Medical Center, Bronx
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Bronx
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18850311
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.
Results Reference
result
PubMed Identifier
21792728
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs