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OpenTrials
Completed

NCT Number: NCT00013325

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VAMC, Palo Alto

Palo Alto, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

SCI patients

Treatment and study plan

Cardiac Disease

Procedure

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
1999
Study completion
2002
First posted
Mar 16, 2001
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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