NCT00013325

Brief Summary

The purpose of this three-year study is to determine the prevalence and incidence of the different types of cardiac disease and ECG abnormalities in SCI patients. Study goals are: (i) delineation of the specific types of heart disease that occur in the SCI population as manifested both pre-clinically and clinically and (ii) demonstration of their association with ECG findings. This will enable validation of scores and algorithms using the inexpensive and widely available ECG for the prevention of heart disease as well as it's early treatment and rehabilitation in SCI patients. The findings will be helpful in demonstrating what cardiological tests are appropriate for the mandated annual evaluation of SCI patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1999

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2001

First QC Date

March 14, 2001

Last Update Submit

January 20, 2009

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury, heart disease, electrocardiography

Interventions

Cardiac DiseasePROCEDURE

Eligibility Criteria

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VAMC, Palo Alto

Palo Alto, California, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesHeart Diseases

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesCardiovascular Diseases

Study Officials

  • John Fryer, Ph.D. Asst. Director

    Deprtment of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

  • Nancy Rocheleau, Program Analyst

    Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Start

October 1, 1999

Study Completion

September 1, 2002

Last Updated

January 21, 2009

Record last verified: 2001-01

Locations

US(1)