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

Spinal Cord Injuries Clinical Trial

Official title:

Systemic Hemodynamics and Cerebral Blood Flow in Persons With Tetraplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248807
• Other study ID #: B3346-V
• Secondary ID: 00517
• Status: Completed
• Phase: N/A
• First received: November 2, 2005
• Last updated: May 21, 2014
• Start date: October 2005
• Est. completion date: April 2012

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Spinal Cord Injuries

Intervention

Drug:
• 1.25 mg enalaprilat IV
an angiotensin converting enzyme (ACE) inhibitor given to lower blood pressure (BP) and measure cerebral blood flow (CBF)

Other:
• Head up tilt (HUT)
45 degree head-up tilt to lower blood pressure and measure cerebral blood flow.

Locations

Country	Name	City	State
United States	VA Medical Center, Bronx	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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