| Version 2.1.1.0 |
|
|
Abstract
Grant Number: 1R44HL069563-01A1 PI Name: SKINNER, JAMES E. PI Email: sskinner@epix.net PI Title: DIRECTOR OF RESEARCH Project Title: PD2i ANALYSIS OF R-R INTERVALS IN HIGH-RISK ER PATIENTS Abstract: DESCRIPTION (provided by applicant): A large unmet need exists in medical markets for a product to assist the Emergency Department physician in the rapid triage of high-risk cardiac-patients. A new cutting-edge device is proposed to reduce physician error as well as hospital costs. The Phase-1 aim is to develop user-friendly analytic software to be used on conventional digital ECG's to predict risk of arrhythmic death. The proposal is supported by results from two independent prospective studies which show that the analysis of heart rate variability (HRV) by the Company's proprietary algorithm is highly predictive of arrhythmic death in ER patients and of all cause mortality in survivors of myocardial infarction. ECG analysis by this proprietary algorithm currently requires experts in signal analysis. The goal of this proposal is to develop software meeting FDA specifications that can be used by actual hospital personnel in an actual clinical situation. The two Specific Aims of this fast-track proposal are 1) the creation of user-friendly software for use by hospital personnel, and 2) the testing and establishment of "good medical practice" through wide experimental use of this software at different Emergency Room sites. Both aims are pivotal for commercialization.
Thesaurus Terms:
arrhythmia, biomedical equipment development, cardiovascular disorder diagnosis, cardiovascular disorder risk, computer assisted patient care, computer program /software, computer system design /evaluation, diagnosis design /evaluation, electrocardiography, emergency service
computer human interaction, heart rate, patient safety /medical error
Institution: VICOR TECHNOLOGIES, INC. 2300 NW CORPORATE BLVD, STE 123 BOCA RATON, FL 33431 Fiscal Year: 2003 Department: Project Start: 01-APR-2003 Project End: 30-SEP-2003 ICD: NATIONAL HEART, LUNG, AND BLOOD INSTITUTE IRG: ZRG1