Clinical Trials

This article describes the clinical trials that Cardionetics has conducted to validate and demonstrate the performance of the C.Net5000 and C.Net2000+ ambulatory ECG monitors.

Comparison with Cardiologists

The analysis of ECG data performed by the C.Net2000+ has been validated against the performance of gold standard cardiology specialists in clinical trials sponsored by the British Heart Foundation and carried out at St. George’s Hospital in London [1]. The C.Net2000+ achieved an accuracy level of 96%, which compares well with individual cardiologists, who averaged 91.4%. Moreover, the C.Net2000+ maintains a 100% consistency of diagnosis, eliminating human observer variability, which can be as high as 30%. The capability of the C.Net2000+ and C.Net5000 allows routine tests to be performed automatically and immediately at the primary care level prior to referral to a cardiologist.

Comparison with General Practitioners

A year-long planned, open, prospective study involving fifty-three GPs in 16 surgeries examined the practicality of carrying out 24-hour ambulatory ECG arrhythmia testing in primary care.

Interim results of the study were published in the British Journal of Cardiology [2], showing a 60% reduction in referrals to cardiology outpatients departments. Of the 26% who were referred, almost one third would not have been, had the GP not had access to a Cardionetics ECG monitor. The false negative rate for urgent referrals also improved when GPs used the C.Net2000+, only 15% of referrals being identified as urgent by the GP when not using the C.Net2000+, rising to 37% of referrals when using the equipment.

The results have positive implications for meeting the 18-week delivery target and Quality and Outcomes Framework (QOF) as well as improving patient care as a result of earlier diagnosis.

Use in General Practice

A clinical case-study paper has been published by Dr Kassianos, a general practitioner who uses the Cardionetics C.Net2000+ [3]. It describes two cases where use of the monitor resulted in early diagnosis and rapid treatment with satisfactory outcomes.

A follow-up study by Dr Kassianos examined records from 52 patients patients undergoing ECG monitoring in a primary care practice over a two-year period. The study showed that ambulatory ECG monitoring proved feasible and useful in primary care. Results were used as the basis of referrals for 50% of patients tested, and to inform initiation or changes of medication in a further 24% of patients [4].

References

[1] L. Gamlyn, P. Needham, S. M. Sopher, T. J. Harris, The development of a neural network-based ambulatory ECG monitor, Neural Computing and Applications, 1999, Vol. 8, pp. 273–378.

[2] P. Standing, M. Dent, A. Craig, B. Glenville, Changes in referral patterns to cardiac outpatient clinics with ambulatory ECG monitoring in general practice, British Journal of Cardiology, 2001, Vol. 8 No. 6, pp. 394–398.

[3] A. K. J. Mandal, C. G. Missouris, G. G. Kassianos, Palpitations and syncope in primary care, British Journal of Cardiology, 2004, Vol. 11 No. 6, pp. 492–494. View

[4] G. Kassianos, Ambulatory ECG monitoring in primary care, Primary Care Cardiovascular Journal, July 2008, Vol. 1, No. 2. View