NCT00248807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 23, 2014

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

3.6 years

First QC Date

November 2, 2005

Results QC Date

September 12, 2013

Last Update Submit

February 5, 2025

Conditions

Orthostatic HypotensionSpinal Cord Injuries

Keywords

Blood Pressure, LowHypotension, PosturalInjuries, Spinal CordSpinal Cord TransectionSpinal Cord Trauma

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    Systolic blood pressure during head-up tilt in subjects with spinal cord injury without drug intervention

    acute testing

Secondary Outcomes (1)

  • Cerebral Blood Flow

    acute testing

Study Arms (4)

ARM 1

PLACEBO COMPARATOR

Head-up tilt maneuver without drug in subjects with spinal cord injury

Other: Head up tilt (HUT)

ARM 3

PLACEBO COMPARATOR

Head-up tilt maneuver without drug in able-bodied controls

Other: Head up tilt (HUT)

ARM 2

ACTIVE COMPARATOR

Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in subjects with spinal cord injury

Drug: 1.25 mg enalaprilat IVOther: Head up tilt (HUT)

ARM 4

ACTIVE COMPARATOR

Head-up tilt maneuver with an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat) in able-bodied controls.

Drug: 1.25 mg enalaprilat IVOther: Head up tilt (HUT)

Interventions

1.25 mg enalaprilat IVDRUG

an angiotensin converting enzyme (ACE) inhibitor given to lower blood pressure (BP) and measure cerebral blood flow (CBF)

ARM 2ARM 4
Head up tilt (HUT)OTHER

45 degree head-up tilt to lower blood pressure and measure cerebral blood flow.

ARM 1ARM 2ARM 3ARM 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Related Publications (1)

  • 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/s10286-008-0496-6. Epub 2008 Oct 11.

    PMID: 18850311RESULT

MeSH Terms

Conditions

Hypotension, OrthostaticSpinal Cord InjuriesHypotension

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Limitations and Caveats

Did not assess carbon dioxide levels or the severity of spinal cord injury, which may have contributed to the results.

Results Point of Contact

Title
Dr. Jill M. Wecht; Principal Investigator
Organization
James J Peters VAMC
JM.Wecht@va.gov
718 584-9000

Study Officials

  • Jill Wecht, EdD

    VA Medical Center, Bronx

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2005

First Posted

November 4, 2005

Study Start

October 1, 2005

Primary Completion

May 1, 2009

Study Completion

April 1, 2012

Last Updated

February 25, 2025

Results First Posted

June 23, 2014

Record last verified: 2025-02

Locations

US(1)