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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


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
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