Spinal Cord Injury Clinical Trial
Official title:
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.
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Time Perspective: Prospective
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