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Cardiac Disease and the Electrocardiogram in SCI Patients

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013325
First received: March 14, 2001
Last updated: January 20, 2009
Last verified: January 2001

March 14, 2001
January 20, 2009
October 1999
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Complete list of historical versions of study NCT00013325 on ClinicalTrials.gov Archive Site
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Cardiac Disease and the Electrocardiogram in SCI Patients
Cardiac Disease and the Electrocardiogram in SCI Patients

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.

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 seen at the PAVA SCIC and their association. Study goals include: 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. Our findings will be helpful in demonstrating what cardiological tests are appropriate for the mandated annual evaluation of SCI patients.

There are two components to this study:

An outcomes component to complete information previously gathered in clinical and computerized databases of 800 SCI patients and a convenience sample of age-matched able-bodied veterans and perform a follow up for cardiac events.

A screening component to identify pre-clinical disease will include Holter ECG recordings and echocardiograms on patients without symptoms or evidence for heart disease seen in the SCI center during the course of the study and age-matched able-bodied veterans.

Hypothesis (a): The prevalence and incidence of cardiac diseases including coronary artery disease and cardiomyopathy will be higher in the SCI population than age-matched samples of the able-bodied population while valvular disease and arrhythmia will be similar. (b): The prevalence and incidence of cardiac disease in SCI individuals will be associated with level and completeness of injury (ie, higher occurrence in those with higher lesion levels and more complete injuries.) (c) The ECG will be helpful in SCI patients in early identification and secondary prevention of both ischemic and cardiomyopathic heart disease. (d) Continuous Holter ECG recordings or echocardiograms will only be indicated for screening specific SCI patients identified by clinical and electrocardiographic features.

Observational
Time Perspective: Prospective
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Spinal Cord Injury
Procedure: Cardiac Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
800
September 2002
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SCI patients

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00013325
B2140R
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Department of Veterans Affairs
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Investigator: John Fryer, Ph.D. Asst. Director Deprtment of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Investigator: Nancy Rocheleau, Program Analyst Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Department of Veterans Affairs
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP