Apparatus and method for identifying myocardial ischemia using analysis of high frequency QRS potentials

• US 8,538,510 B2
• Filed: 08/02/2007
• Issued: 09/17/2013
• Est. Priority Date: 08/03/2006
• Status: Active Grant

• Current Assignee: BSP Medical Limited
• Original Assignee: Bsp Biological Signal Processing Ltd.
• Inventors: Toledo, Eran, Beker, Amir, Bregman-Amitai, Orna
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US12/375,544
• Publication Number:
  US 20090318820A1
• Time in Patent Office: 2,238 Days
• Field of Search: 600508-528, 607/9, 607/14, 607 4- 5
• US Class Current: 600/509
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61B 5/6804 Garments; Clothes
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

Detecting cardiac ischemia by detecting local changes in high frequency ECG parameters. Local changes may be, for example, local reduction in RMS of high frequency components, for example, during a stress test.

Claims

1. A method for analyzing ECG signals, comprising:

(a) providing at least one ECG signal recorded from a body;

(b) having a computer determine the value of at least one time-varying parameter of a high frequency band of said ECG signal; and

(c) having a computer generate an alert responsive to a decision algorithm comprising a set of rules involving a combination of;

an instant variation of the time-varying parameter value during a test, wherein said instant variation is a change in the parameter value in comparison to the parameter value at a short time before; and

a physiological analysis of a low-frequency component of said ECG signal, producing at least one physiological consideration,

wherein said alert comprises indicating ischemia.

2. A method according to claim 1, wherein said time-varying parameter is an amplitude related parameter.

3. A method according to claim 1, wherein said instant variation is a change compared to a value under similar conditions at a different time.

4. A method according to claim 1, wherein said test comprises a stress test.

5. A method according to claim 4, wherein said instant variation is a change relative to a maximum stress condition.

6. A method according to claim 1, wherein said test comprises a monitoring event.

7. A method according to claim 1, wherein said test comprises a treatment event.

8. A method according to claim 1, wherein said test comprises a monitoring of at least 1 hour.

9. A method according to claim 1, wherein said test comprises a monitoring of at least 2 hours.

10. A method according to claim 1, wherein generating an alert comprises performing an additional test.

11. A method according to claim 1, wherein said at least one additional physiological consideration comprises an absolute change in a high frequency time-varying parameter.

12. A method according to claim 1, wherein the ECG signal is sampled from a plurality of leads.

13. A method according to claim 12, wherein a lead with a high level of noise is discarded from the diagnosis.

14. A method according to claim 12, wherein an ischemia diagnosis depends on the analysis results of multiple leads.

15. A method according to claim 14, wherein a lead value is weighted according to its noise level.

16. A method according to claim 1, in which the short time is 10 seconds to 5 minutes.

17. A method according to claim 1, in which the short time is 1 minute to 5 minutes.

18. A method according to claim 1, in which the short time is 5 minutes or less.

19. A method according to claim 1, wherein said at least one physiological consideration is one of a group comprising:

QRS duration of at least one QRS complex;

level of an ST segment of at least one QRST complex;

presence of an up-sloping ST segment in at least one QRS complex;

presence of a down-sloping ST segment in at least one QRS complex;

presence of a horizontal ST segment in at least one QRS complex;

QT interval duration in at least one QRS complex;

QTc interval duration in at least one QRS complex; and

PR interval duration in at least one QRS complex.

20. A method according to claim 1 in which said physiological analysis of said low-frequency component of said ECG signal is performed in addition to any alignment of high frequency signals from said high frequency band of said ECG signal.

21. A method according to claim 1 in which said set of rules involves at least one of following:

a vector of primary indices, a vector of secondary HF indices, a vector of primary ECG indices and a vector of secondary ECG indices.

22. A method of detecting an ischemic event, comprising:

(a) having a computer scan a high frequency (HF) band of an ECG signal collected from a plurality of heartbeats to detect an instant variation in a value of at least one time-varying parameter, wherein said instant variation is a change in value of said parameter, compared to the parameter value at a short time before;

(b) having a computer perform a physiological analysis of a low-frequency component of the ECG signal; and

(c) having a computer identify a combination of the change and the analysis as being indicative of a potential ischemic event responsive to a decision algorithm comprising a set of rules.

23. A method according to claim 22, wherein said change comprises a reduction in HF amplitude.

24. A method according to claim 22, comprising further having a computer analyze additional data associated with said potential event to increase a reliability of said identifying, wherein the additional data comprises an analysis of said low-frequency component of said ECG signal.

25. A method according to claim 22, wherein said scanning comprises scanning in a monitoring setting.

26. A method according to claim 22, wherein said scanning comprises scanning in a stress-testing setting.

27. Apparatus for ECG signal analysis, comprising:

(a) an input for an ECG signal;

(b) a high-frequency band extractor which extracts a high frequency (HF) band from said signal;

(c) a filter configured to analyze said HF band and detect an instant variation, wherein said instant variation is a change in value of a time-varying parameter in comparison to the parameter value at a short time before;

(d) a processor configured to analyze low frequency components of said ECG signal, producing at least one physiological consideration; and

(e) an output which generates an output signal responsive to a decision algorithm comprising a set of rules involving a combination of the instant variation and the analysis of the low frequency components.

28. Apparatus according to claim 27, mounted as a wearable ECG monitor.

29. Apparatus according to claim 27, configured as a part of an implantable device.

30. Apparatus according to claim 27, configured as a part of an exercise stress test system.

31. Apparatus according to claim 27, wherein said filter analyses said HF band using a cross-correlation method to detect said instant variation.

32. Apparatus according to claim 27, wherein said filter analyses said HF band to determine a change in a kurtosis parameter.

33. Apparatus according to claim 27, comprising a memory adapted to store a reference value from a different session.