A Study of Blood Pressure and Blood Supply to the Brain in Persons With a Spinal Cord Injury.
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on February 12, 2009 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Orthostatic Hypotension; Spinal Cord Injuries
Intervention: 1.25 mg enalaprilat IV (Drug); Head up tilt (HUT) (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s): Jill Wecht, EdD, Principal Investigator, Affiliation: VA Medical Center, Bronx
Overall contact: Jill Wecht, EdD, Email: jm.wecht@va.gov
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.
Clinical Details
Official title: Systemic Hemodynamics and Cerebral Blood Flow in Persons With Tetraplegia
Study design: Health Services Research, Non-Randomized, Open Label, Parallel Assignment
Primary outcome: cerebral blood flow and blood pressure
Detailed description:
Individuals with tetraplegia lack normal sympathetic nervous system regulation of blood
pressure and therefore, relative hypotension is a common occurrence, which 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 however, 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-angiotension 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Duration of spinal cord injury (SCI) 1 year
2. Level of SCI C4-8 and T6 and below
3. matched non-SCI subjects
4. Chronological age between 18-65 years
5. 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:
1. Known heart and/or blood vessel disease
2. Dehydration
3. High blood pressure
4. Kidney disease
5. Diabetes mellitus
6. Prescribed ACE inhibitors
7. Infection
8. Smoking
9. Pregnancy
Locations and Contacts
Jill Wecht, EdD, Email: jm.wecht@va.gov
VA Medical Center, Bronx, Bronx, New York 10468, United States; Recruiting Dwindally Rosado Rivera, EdD, Phone: 718-584-9000, Ext: 3128, Email: dwindally.rosadorivera@va.gov Jill Wecht, EdD, Principal Investigator
Additional Information
Starting date: October 2005
Ending date: October 2009
Last updated: September 9, 2008
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