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A Study of Blood Pressure and Blood Supply to the Brain in Persons With a Spinal Cord Injury.
This study is ongoing, but not recruiting participants.
First Received: November 2, 2005   Last Updated: August 25, 2009   History of Changes
Sponsor: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00248807
  Purpose

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.


Condition Intervention
Orthostatic Hypotension
Spinal Cord Injuries
Drug: 1.25 mg enalaprilat IV
Other: Head up tilt (HUT)

Study Type: Interventional
Study Design: Health Services Research, Non-Randomized, Open Label, Parallel Assignment
Official Title: Systemic Hemodynamics and Cerebral Blood Flow in Persons With Tetraplegia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • cerebral blood flow and blood pressure [ Time Frame: Cerebral blood flow and blood pressure will be measured every 20 and 10 minutes, respectively during the baseline and post-challenge periods. ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: October 2005
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
1.25 mg enalaprilat IV and/or 45 degree HUT to lower BP and measure CBF
Drug: 1.25 mg enalaprilat IV
an ACE inhibitor given to lower BP and measure CBF
Other: Head up tilt (HUT)
45 degree HUT to lower BP and measure CBF

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 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-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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Duration of spinal cord injury (SCI) at least 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. Acute Infection
  8. Smoking
  9. Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248807

Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Investigators
Principal Investigator: Jill Wecht, EdD VA Medical Center, Bronx
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Wecht, Jill - Principal Investigator )
Study ID Numbers: B3346V, 00517
Study First Received: November 2, 2005
Last Updated: August 25, 2009
ClinicalTrials.gov Identifier: NCT00248807     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Blood Pressure, Low
Hypotension, Postural
Injuries, Spinal Cord
Spinal Cord Transection
Spinal Cord Trauma

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Molecular Mechanisms of Pharmacological Action
Spinal Cord Diseases
Nervous System Diseases
Vascular Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Enzyme Inhibitors
Cardiovascular Agents
Trauma, Nervous System
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Spinal Cord Injuries
Enalaprilat
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010