University of Mississippi Medical Center
Vicor is collaborating with the University of Mississippi Medical Center on several trials:
Normal Range Study
This important study will enable Vicor to identify normal ranges for PD2i® values obtained from tests performed with its PD2i Analyzer™ on patients at rest, and in response to controlled exercise and paced respiration.
Study to Assess Concussions in NCAA Athletes
In collaboration with Belhaven University, Vicor scientists are studying the use of heart rate variability, as measured by Vicor’s PD2i Analyzer™, to assess concussions in competitive athletes.
Brain Injury Risk Stratification Trial (BIRST)
BIRST will enable Vicor to determine the ability of the PD2i® nonlinear algorithm to predict mortality in victims of brain trauma.
Brain trauma is a serious public health challenge in the U.S., with more than 300,000 sport-related traumatic brain injuries reported annually. According to the Brain Trauma Foundation, there are approximately 52,000 deaths annually from traumatic brain injury.
Cardiac Arrhythmia Assessment and Safety in Student Athletes (CAASSA) Trial
Cardiac death is a leading cause of death among student athletes. The goal of this long-term study is to test the ability of the PD2i CA™ to identify student athletes at risk cardiac death.
Complexity Analysis Studies of Trauma in the Emergency Department (CASTED) Trial
A Level 1 trauma center, the University of Mississippi Medical Center Trauma Center is an ideal location to complete additional testing of the PD2i VS™ on civilian trauma victims. Vicor is currently in discussions to identify a means of transmitting PD2i VS™ data for analysis obtained during medivac transport.
Complexity Analysis During Blood Donation (CABLD) Trial
The goal of this pilot study, conducted in cooperation with Mississippi Blood Services, was to test the ability of Vicor’s PD2i® nonlinear algorithm to identify acute hypovolemia in blood donors as a preliminary step toward ascertaining whether it could be a useful noninvasive diagnostic for detecting blood loss from internal bleeding. All 18 participants in the pilot study were tested prior to donation to determine a baseline PD2i® value, and re-tested during and after collection. The average PD2i® value of participants prior to donation was 2.60; the average PD2i® value following donation was 1.80. With a P value of 0.001, the study results are highly statistically significant; this indicates a better than 99% probability that the results were not achieved randomly.
Complexity Analysis During Renal Dialysis (CARD) Trial
The CARD Trial will use the PD2i Analyzer™ to measure heart rate variability as a means of determining the acute effects of fluid loss during dialysis.
Massachusetts General Hospital
MGH PD2i VS™ Trial
In this study, Massachusetts General Hospital will test the PD2i VS™ for real-time mobile and ICU triage use in an extremely demanding emergency medical environment.
The teaching hospital for Harvard Medical School, MGH is a Level 1 Adult, and Level 1 Pediatric and Trauma Center admitting an average of 4,200 trauma patients and an additional 2,000 emergency surgery patients annually. MGH is also a Level 1 Burn Center and one of the few centers nationwide with the highest level of accreditation from the American College of Surgeons in adult trauma care, pediatric trauma care, and burn care.
Dr. Alfred Buxton
Vicor will be working with renowned electrophysiologist Dr. Alfred Buxton on two trials to learn whether measuring heart rate variability is useful in tracking the progress of cardiac patients undergoing various rehabilitative treatments following ICD implantation.
Dr. Buxton is a Professor of Medicine at Brown Medical School and Director of the Cardiology Division at Brown Medical School, and at Rhode Island and Miriam hospitals. He is also the Director of Arrhythmia Services and the Clinical Cardiac Electrophysiology Laboratory at Rhode Island and Miriam hospitals.
CARE-t Trial
Vicor’s PD2i Analyzer™ will be used to measure heart rate variability as a means of determining the efficacy of cognitive behavioral therapy on cardiac patients with ICDs.
CARE-e Trial
Vicor’s PD2i CA™ will be used to determine the ability of exercise to reduce arrhythmias in cardiac patients with ICDs.
University of Rochester/Catalan Institute of Cardiovascular Sciences
On July 1 we announced submission of a 510(k) premarket notification to the FDA for the PD2i® nonlinear algorithm and software to secure a claim for identifying, in conjunction with patient medical history and other tests, congestive heart patients at elevated risk of cardiac mortality.
This filing is based on findings obtained from “Prognostic Significance of Point Correlation Dimension Algorithm (PD2i) in Chronic Heart Failure,” a study conducted under a collaborative agreement with the University of Rochester and the Catalan Institute of Cardiovascular Sciences in Barcelona. The goal of the study was to evaluate the ability of Vicor’s PD2i® nonlinear algorithm to predict cardiac events in the 537 chronic heart failure patients enrolled in the Merte Subita en Insufficiencia Cardiaca (MUSIC) Trial; MUSIC Trial participants were followed for an average period of 44 months. The conclusion of the University of Rochester researchers who conducted the study is that the PD2i® nonlinear algorithm and software is predictive of total mortality, cardiac death, and heart failure death in patients with left ventricular ejection fraction of less than or equal to 35%. With a P value of 0.004 the study results are highly statistically significant.
This filing brings us one step closer to being able to market our PD2i® nonlinear algorithm and software to cardiologists, and enabling them to more effectively identify their congestive heart failure patients at elevated risk of cardiac mortality.
Universidad San Francisco de Quito – Ecuador
To date, two studies have evolved from Vicor’s relationship with the USFQ. As announced on February 23, Vicor entered into a collaborative agreement with the USFQ to further awareness and use of the measure of heart rate variability as a medical diagnostic. Under the terms of the agreement, Vicor is collaborating with the USFQ to:
- develop academic programs that advance awareness and use of the measure of heart rate variability (HRV) to diagnose various medical disorders within a variety of health-challenged and/or at risk populations;
- promote continued research into the uses of HRV in USFQ clinics, and
- stimulate assistance from Ecuador’s public and private health sectors with the goal of preventing disease with appropriate intervention/treatment based on early diagnosis using HRV.
Dr. Weiss is working with Dr. Michelle Grunauer, Project Manager of the USFQ HRV Institute, to develop the protocol for a study to identify disabled Ecuadorans at elevated risk of sudden cardiac death and/or autonomic neuropathy using the PD2i® nonlinear algorithm. A population of approximately 4,700 disabled individuals — of all ages (infant to elder) and socio-economic background, from seven provinces – has been identified for screening. The goal of the study is to determine the ability of the PD2i® to serve as a diagnostic that will identify those in this population in need of immediate access to care.
Additionally, Vicor is working with Ecuadoran government and military officials on a classified study involving military hospital patients.
U.S. Army Institute of Surgical Research
Vicor and the U.S. Army Institute of Surgical Research (USAISR) are testing the PD2i VS™ in combat casualties and ICU patients. Various experiments have been successfully performed, and the USAISR and Vicor have presented the findings in leading journals and at conferences in the U.S. and Europe.
Vicor expects to submit the results of these studies to the FDA in a 510(k) for marketing approval for trauma in 2010.
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