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

Not Applicable

Completed

• Conditions: Orthostatic Hypotension; Spinal Cord Injuries
• Interventions: Other: Head up tilt (HUT); Drug: 1.25 mg enalaprilat IV

• Registration Number: NCT00248807
• Lead Sponsor: US Department of Veterans Affairs

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-02
• Study First Submitted QC: 2005-11-02
• Study First Posted: 2005-11-04
• Primary Completion: 2009-05
• Study Completion: 2012-04
• Results First Submitted: 2013-09-12
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-21
• Last Update Submitted: 2014-05-21
• Results First Posted: 2014-06-23
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Read More

Exclusion Criteria

• Known heart and/or blood vessel disease
• Dehydration
• High blood pressure
• Kidney disease
• Diabetes mellitus
• Prescribed ACE inhibitors
• Acute Infection
• Smoking
• Pregnancy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM 1	Head up tilt (HUT)	Head-up tilt maneuver without drug in subjects with spinal cord injury
ARM 3	Head up tilt (HUT)	Head-up tilt maneuver without drug in able-bodied controls
ARM 2	1.25 mg enalaprilat IV	Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in subjects with spinal cord injury
ARM 2	Head up tilt (HUT)	Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in subjects with spinal cord injury
ARM 4	1.25 mg enalaprilat IV	Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in able-bodied controls.
ARM 4	Head up tilt (HUT)	Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in able-bodied controls.

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	acute testing	Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention

Secondary Outcome Measures

Name	Time	Method
Cerebral Blood Flow	acute testing	Measurement of middle cerebral artery blood flow velocity supine and during head-up tilt

Trial Locations

Locations (1)

VA Medical Center, Bronx; 🇺🇸 Bronx, New York, United States