NEWS!Heartlink Canada (1999) Inc.
1/11/01 - Scientific Research and Validation Program Announcement
HEARTLINK CANADA INC ("HLC-V") - Scientific Research and Validation Program Announcement
HeartLink Canada (1999) Inc. (the "Company"). The Company is developing a new methodology for the identification of psychiatric disorders based on objective data derived from 24-CHP (Circadian Heart Pattern) recordings. The company has been sponsoring clinical trials and other scientific research projects to further study the relationship between psychiatric illness and circadian heart rate patterns. In addition, the company is evaluating other methods for identifying aberrant symptoms, physiology, and behavior associated with mental illness that correlate with and support the 24-CHP technology.
The first clinical trial is a small part of an overall program of research and development to validate, further refine, and automate the interpretation of 24-CHP data. The 24-CHP technology serves as the foundation of a commercial laboratory service that will produce reports to assist physicians with the identification of psychiatric illness and the ongoing monitoring of treatment. It is expected that automation will provide a higher degree of reliability and clinical accuracy over manual interpretation that was used in the first clinical trial.
The investigators for the first trial were Dr. Ronald Remick, Consultant Psychiatrist of St. Paul's Hospital, Dr. Peter McLean, Professor, Department of Psychiatry, University of British Columbia and Dr. Wolfgang Linden, Professor, Department of Psychology at University of British Columbia. The trial was managed by Moncoa Medical Research Inc., an independent company that specializes in clinical trial management, monitoring, and coordinating. The Company announces that a major milestone in the ongoing confirmation work has been completed. A summary of the preliminary results is provided below.
OBJECTIVE OF THE TRIAL AND METHODOLOGY
To determine if an objective biological marker (i.e. heart rate pattern) for mood state (depression) improves diagnostic accuracy?
In order to evaluate the effectiveness of 24-CHP, 20 family physicians referred a total of 120 patients to the trial who, in the physicians' view, were either (1) clearly depressed, (2) may have been depressed, or (3) were clearly not depressed. The patients underwent structured clinical interviewing and were then given a variety of psychological tests, all of which are subjective in nature. The patients were also monitored with the objective 24- CHP technology.
PRELIMINARY CONCLUSION
The double blind clinical trial confirmed that there is a relationship between cardiac physiology and psychiatric illness. Persons with depression and other forms of psychiatric illness frequently showed disturbed cardiac physiology, as measured by the 24-CHP technology.
The patients with psychiatric problems (as identified by the interview and psychological tests) were classified in the following manner by the 24-CHP technology: (1) 86.4% showed unhealthy cardiac physiology, (2) 9.1% showed "borderline" cardiac physiology, and (3) 4.5% showed broadly normal cardiac physiology. Thus, manual interpretation of the 24-CHP technology was very sensitive to unhealthy cardiac physiology associated with psychiatric illness.
Of the patients who did not have obvious psychiatric disorders (as identified by the traditional, yet subjective, measures), 64% were also identified as having unhealthy cardiac physiology. As these patients were selected for the trial by their general practitioners upon presentation to their consulting rooms for other ailments, it was not surprising that upon further investigation, a number of these patients were identified as suffering from situational stress, migraines, pain, sleep disturbance, and/or other factors reported and recorded at the time of monitoring. Thus, the 24-CHP may also be identifying unhealthy physiology associated with other factors in addition to psychiatric illness.
This clinical trial relied on a single rater who was blind to all information regarding the patients. Under these circumstances, it is expected that there would be an over-identification of patients as showing disturbed circadian physiology associated with mental illness. This is because patients with factors that may cause similar features were not identified and removed from the analyses, as they can be in normal daily practice.
The clinical trial has produced valuable data for better understanding the relationship between disturbed cardiac physiology and psychiatric illness. Moreover, these findings directed the Company to engage in a refined research program to design improved discrimination criteria that may be included in the automation of report generation.
ONGOING RESEARCH & DEVELOPMENT
The central goal of the research and development program is to identify, and automate the interpretation of, those cardiac factors that are most highly related to aberrant physiology associated with mental illness. The technology currently is in transition from manual (i.e., human raters) to partial automation (identification of factors through mathematical algorithms). The company expects to develop full automation.
The company is currently ahead of schedule in the transition toward partial automation. Data from the first clinical trial have been used to illustrate how applying mathematical algorithms can reduce human variability in rating, and result in a much lower false positive rate. These results are currently under peer review for presentation at North American scientific conferences.
The following example illustrates the results of a transition from manual to partially automated interpretation of 24-CHP recordings. Two cleanly defined groups, based on clinical data, were selected from the Vancouver Trial database. The healthy group was composed of 22 individuals who had no obvious evidence of a mental health problem. The depressed group was composed of 30 patients who had converging evidence of a significant mental health problem. Manual interpretation was compared to two types of automated interpretation criteria that were based entirely on mathematical algorithms (no human judgment).
Classification of Cardiac Physiology
Manual Interpretation Broadly Normal Borderline Unhealthy
Healthy Group 31.8% 27.3% 40.9%
Depressed Group 7.1% 14.3% 78.6%
Algorithm No. 1
Healthy Group 91% (xxx) 9%
Depressed Group 47% (xxx) 53%
Algorithm No. 2
Healthy Group 82% (xxx) 18%
Depressed Group 20% (xxx) 80%
As seen in the Table, it is possible to greatly reduce the number of false positives, from 41% to 9%, by utilizing algorithm No. 1. The correct classification identification rate for depressed subjects using this algorithm is 53%. Using algorithm No. 2, it is possible to classify 80% of each group correctly.
FUTURE DIRECTIONS
Data from the first clinical trial, as well as data from other projects, have been used in several additional studies. The company has completed preliminary analyses for more than 10 research projects that establish the foundations of the commercial laboratory service. These research projects have been submitted for presentation at scientific and medical conferences across North America.
The Scientific Validation Program is ongoing. Results, scientific papers, and project details will be posted to the web site as they are completed. In addition, the company will post its program for Professional and Scientific Conference Presentations and Attendances for the 2001 year. It will also post notice of full-length articles submitted and accepted for publication by peer reviewed medical journals. TEL: (604) 488-0100 R.F. Baldock, President and CEO
HeartLink Canada (1999) Inc. Internet: www.heartlinkcanada.com E-mail: admin@heartlinkcanada.com