Cardiac Disease and the Electro Cardiogram in SCI Patients

This study is currently recruiting patients.

Sponsored by

Department of Veterans Affairs

Purpose

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.


Condition Treatment or Intervention Phase Spinal Cord Injury

Procedure:Cardiac Disease

Phase II

MEDLINEplusrelated topics:SpinalCordInjuries

Study Type:Observational
Study Design:Screening,Longitudinal,Defined Population,Prospective Study

Further Study Details:


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.


Eligibility

Ages Eligible for Study: 18 Years and above , Genders Eligible for Study: Both

Participants: Patients

Criteria

SCI patients

Expected Total Enrollment: 800

Location and Contact Information

Victor Froelicher, M.D. (650) 493-5000 vicmd@aol.com

California
VAMC, Palo Alto,Palo Alto, California, United States;Recruiting

Victor Froelicher, MD 650-493-5000

Study chairs or principal investigators

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

More Information

Study ID Numbers B2140
NLM Identifier NCT00013325

Date study startedOctober 1999; Date Study Completed September 2002 Record last reviewed January 2001