Method and system for evaluating and locating cardiac ischemia

• US 20020165459A1
• Filed: 12/26/2001
• Published: 11/07/2002
• Est. Priority Date: 06/26/2000
• Status: Active Grant

• Current Assignee: Mediwave Star Technology Incorporated
• Original Assignee: Mediwave Star Technology Incorporated
• Inventors: Starobin, Joseph M., Chernyak, Yuri B.
• Granted Patent: US 6,648,829 B2
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/36 Detecting PQ interval, PR interval or QT interval
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening

Abstract

A method of assessing cardiac ischemia in a subject to provide a measure of cardiac or cardiovascular health in that subject is described herein. The method comprises the steps of: (a) collecting a first RR-interval data set from the subject during a stage of gradually increasing heart rate (e.g., a stage of gradually increasing exercise load); (b) collecting a second RR-interval data set from the subject during a stage of gradually decreasing heart rate (e.g., a stage of gradually decreasing exercise load); (c) comparing the first RR-interval data set to the second RR-interval data set to determine the difference between the data sets; and (d) generating from the comparison of step (c) a measure of cardiac ischemia during exercise in the subject. A greater difference between the first and second data sets indicates greater cardiac ischemia and lesser cardiac or cardiovascular health in the subject. The data sets are collected with a plurality of separate electrodes indicative of different regions of the heart so that the generating step can include locating the region of greatest ischemia by comparing the amount of ischemia indicated in each region.

Claims

1. A method of assessing cardiac ischemia in a subject to provide a measure of cardiac or cardiovascular health in that subject, said method comprising the steps of:

(a) collecting a first RR-interval data set from said subject during a stage of gradually increasing heart rate;

(b) collecting a second RR-interval data set from said subject during a stage of gradually decreasing heart rate, with said first and second RR-interval data sets being collected while minimizing the influence of rapid transients due to autonomic nervous system and hormonal influence on said data sets;

(c) comparing said first RR-interval data set to said second RR-interval data set to determine the difference between said data sets; and

(d) generating from said comparison of step (c) a measure of cardiac ischemia during stimulation in said subject, wherein a greater difference between said first and second data sets indicates greater cardiac ischemia and lesser cardiac or cardiovascular health in said subject;

wherein said first and second RR-interval data sets are collected from a plurality of separate electrode leads,

and wherein said generating step includes the step of generating an indication of the location of cardiac ischemia in said subject.

2. The method according to claim 1, wherein said first and second RR-interval data sets are collected under quasi-stationary conditions.

3. The method according to claim 1, wherein said stage of gradually increasing heart rate and said stage of gradually decreasing heart rate are each at least 3 minutes in duration.

4. The method according to claim 1, wherein said stage of gradually increasing heart rate and said stage of gradually decreasing heart rate are together carried out for a total time of from 6 minutes to 40 minutes.

5. The method according to claim 1, wherein:

both said stage of gradually increasing heart rate and said stage of gradually decreasing heart rate are carried out between a peak rate and a minimum rate; and

said peak rates of both said stage of gradually increasing heart rate and said stage of gradually decreasing heart rate are the same.

6. The method according to claim 5, wherein:

said minimum rates of both said stage of gradually increasing heart rate and said stage of gradually decreasing heart rate are substantially the same.

7. The method according to claim 1, wherein said stage of gradually decreasing heart rate is carried out at at least three different heart-rate stimulation levels.

8. The method according to claim 7, wherein said stage of gradually increasing heart rate is carried out at at least three different heart-rate stimulation levels.

9. The method according to claim 1, wherein said stage of gradually increasing heart rate and said stage of gradually decreasing heart rate are carried out sequentially in time.

10. The method according to claim 1, wherein said stage of gradually increasing heart rate and said stage of gradually decreasing heart rate are carried out separately in time.

11. The method according to claim 1, wherein said generating step is carried out by generating curves from each of said data sets.

12. The method according to claim 11, wherein said generating step is carried out by comparing the shapes of said curves from data sets.

13. The method according to claim 11, wherein said generating step is carried out by determining a measure of the domain between said curves.

14. The method according to claim 11, wherein said generating step is carried out by both comparing the shapes of said curves from data sets and determining a measure of the domain between said curves.

15. The method according to claim 11, further comprising the step of displaying said curves.

17. The method according to claim 1, wherein said heart rate during said stage of gradually increasing heart rate exceeds 120 beats per minute.

18. The method according to claim 1, further comprising the step of:

(e) comparing said measure of cardiac ischemia during stimulation to at least one reference value; and

then

(f) generating from said comparison of step (e) a quantitative indicium of cardiac or cardiovascular health for said subject.

19. The method according to claim 18, further comprising the steps of:

(g) treating said subject with a cardiovascular therapy; and

then

(h) repeating steps (a) through (f) to assess the efficacy of said cardiovascular therapy, in which a decrease in the difference between said data sets from before said therapy to after said therapy indicates an improvement in cardiac health in said subject from said cardiovascular therapy.

20. The method according to claim 19, wherein said cardiovascular therapy is selected from the group consisting of aerobic exercise, muscle strength building, change in diet, nutritional supplement, weight loss, stress reduction, smoking cessation, pharmaceutical treatment, surgical treatment, and combinations thereof.

21. The method according to claim 18, further comprising the step of assessing from said quantitative indicum the likelihood that said subject is at risk to experience a future ischemia-related cardiac incident.

16. The method according to claim l, wherein said heart rate during said stage of gradually increasing heart rate does not exceed more than 120 beats per minute.

22. A method of assessing cardiac ischemia in a subject to provide a measure of cardiac or cardiovascular health in that subject, said method comprising the steps of:

(a) collecting a first RR-interval data set from said subject during a stage of gradually increasing exercise load and gradually increasing heart rate; and

then, without an intervening rest stage,

(b) collecting a second RR-interval data set from said subject during a stage of gradually decreasing exercise load and gradually decreasing heart rate;

(c) comparing said first RR-interval data set to said second RR-interval data set to determine the difference between said data sets; and

(d) generating from said comparison of step (c) a measure of cardiac ischemia during exercise in said subject, wherein a greater difference between said first and second data sets indicates greater cardiac ischemia and lesser cardiac or cardiovascular health in said subject;

wherein said first and second RR-interval data sets are collected from a plurality of separate electrode leads,

and wherein said generating step includes the step of generating an indication of the location of cardiac ischemia in said subject.

23. The method according to claim 22, wherein said stage of gradually increasing exercise load and gradually decreasing exercise load are each at least 3 minutes in duration.

24. The method according to claim 22, wherein said stage of gradually increasing exercise load and said stage of gradually decreasing exercise load are together carried out for a total time of from 6 minutes to 40 minutes.

25. The method according to claim 22, wherein:

both said stage of gradually increasing exercise load and said stage of gradually decreasing exercise load are carried out between a peak load and a minimum load; and

said peak loads of both said stage of gradually increasing exercise load and said stage of gradually decreasing exercise load are essentially the same.

26. The method according to claim 25, wherein:

said minimum loads of both said stage of gradually increasing exercise load and said stage of gradually decreasing exercise load are essentially the same.

27. The method according to claim 22, wherein said stage of gradually decreasing exercise load is carried out at at least three different load levels.

28. The method according to claim 22, wherein said stage of gradually increasing exercise load is carried out at at least three different load levels.

29. The method according to claim 22, wherein said stage of gradually increasing exercise load and said stage of gradually decreasing exercise load are carried out sequentially in time.

30. The method according to claim 22, wherein said stage of gradually increasing exercise load and said stage of gradually decreasing exercise load are carried out separately in time.

31. The method according to claim 22, wherein said generating step is carried out by generating curves from each of said data sets.

32. The method according to claim 31, wherein said generating step is carried out by comparing the shapes of said curves from said data sets.

33. The method according to claim 31, wherein said generating step is carried out by determining a measure of the domain between said curves.

34. The method according to claim 31, wherein said generating step is carried out by both comparing the shapes of said curves from data sets and determining a measure of the domain between said curves.

35. The method according to claim 31, further comprising the step of displaying said curves.

36. The method according to claim 22, wherein said heart rate during said stage of gradually increasing exercise load does not exceed more than 120 beats per minute.

37. The method according to claim 22, wherein said heart rate during said stage of gradually increasing heart rate exceeds 120 beats per minute.

38. The method according to claim 22, further comprising the step of:

(e) comparing said measure of cardiac ischemia during exercise to at least one reference value; and

then

(f) generating from said comparison of step (e) a quantitative indicium of cardiac or cardiovascular health for said subject.

39. The method according to claim 38, further comprising the steps of:

(g) treating said subject with a cardiovascular therapy; and

then

(h) repeating steps (a) through (f) to assess the efficacy of said cardiovascular therapy, in which a decrease in the difference between said data sets from before said therapy to after said therapy indicates an improvement in cardiac or cardiovascular health in said subject from said cardiovascular therapy.

40. The method according to claim 39, wherein said cardiovascular therapy is selected from the group consisting of aerobic exercise, muscle strength building, change in diet, nutritional supplement, weight loss, stress reduction, smoking cessation, pharmaceutical treatment, surgical treatment, and combinations thereof.

41. The method according to claim 38, further comprising the step of assessing from said quantitative indicium the likelihood that said subject is at risk to experience a future ischemia-related cardiac incident.

42. A method of assessing cardiac ischemia in a subject to provide a measure of cardiac or cardiovascular health in that subject, said method comprising the steps, performed on a computer system, of:

(a) providing a first RR-interval data set collected from said subject during a stage of gradually increasing heart rate;

(b) providing a second RR-interval data set collected from said subject during a stage of gradually decreasing heart rate;

(c) comparing said first RR-interval data set to said second RR-interval data set to determine the difference between said data sets; and

(d) generating from said comparison of step (c) a measure of cardiac ischemia during stimulation in said subject, wherein a greater difference between said first and second data sets indicates greater cardiac ischemia and lesser cardiac or cardiovascular health in said subject;

wherein said first and second RR-interval data sets are collected from a plurality of separate electrode leads,

and wherein said generating step includes the step of generating an indication of the location of cardiac ischemia in said subject.

43. The method according to claim 42, wherein said first and second RR-interval data sets are collected while minimizing the influence of rapid transients due to autonomic nervous system and hormonal control on said data sets

44. The method according to claim 42, wherein said first and second RR-interval data sets are collected without an intervening rest stage.

45. The method according to claim 42, wherein said generating step is carried out by generating curves from each of said data sets.

46. The method according to claim 42, wherein said generating step is carried out by comparing the shapes of said curves from data sets.

47. The method according to claim 42, wherein said generating step is carried out by determining a measure of the domain between said curves.

48. The method according to claim 42, wherein said generating step is carried out by both comparing the shapes of said curves from data sets and determining a measure of the domain between said curves.

49. The method according to claim 42, further comprising the step of displaying said curves.

50. The method according to claim 42, wherein said comparing step is carried out by:

(i) filtering said first and second RR-interval data sets;

(ii) generating a smoothed hysteresis loop from said filtered first and second RR-interval data sets; and

then

(iii) determining the domain of said smoothed hysteresis loop.

51. The method according to claim 42, wherein said comparing step is carried out by:

(i) filtering said first and second RR-interval data sets;

(ii) generating preliminary minima values for said first and second RR-interval data sets;

(iii) correcting said preliminary minima values;

(iv) generating first and second preliminary smoothed curves from each of said filtered data sets;

(v) correcting said preliminary smoothed curves;

(vi) fitting said preliminary smoothed curves;

(vii) generating a smoothed hysteresis loop from said first and second fitted smoothed curves; and

then

(viii) determining the domain of said hysteresis loop.

52. The method according to claim 42, wherein said comparing step is carried out by:

(i) filtering said first and second RR-interval data sets by moving average smoothing;

(ii) generating a smoothed hysteresis loop from said filtered first and second RR-interval data sets; and

then

(iii) determining the domain of said hysteresis loop.

53. The method according to claim 42, wherein said comparing step is carried out by

(i) sequentially combining said first and second RR-interval data sets into one combined RR-interval set;

(ii) filtering said combined RR-interval data sets;

(iii) evaluating coordinates of the minima of said combined and filtered RR-interval data set;

(iv) defining central data subsets including the minima of said combined and filtered RR-interval data set;

(v) fitting each said central data subset with a parabola that has a minimum inside said data subset;

(vi) determining coordinates of the minimum for each said parabola;

(vii) defining reduced data subsets by excluding said central data sets from said combined and filtered RR-interval data set;

(viii) generating a first transformed RR-interval data set by mapping falling off branches of said reduced data sets by a standard monotonously decreasing mapping function of RR-intervals, which depends on at least one discrete or continuous parameter;

(ix) generating a second transformed RR-interval data set by mapping growing branches of said reduced data sets by a standard monotonously increasing mapping function of RR-intervals, which depends on at least one discrete or continuous parameter;

(x) fitting said first and second transformed sets by a standard function of time depending on one or more parameters whose values are determined by the condition of the best fit;

(xi) completing said fitting step by determining the parameters of said mapping fumctions of RR-intervals by the condition of the best fit for each branch of said RR-interval data set;

(xii) generating a hysteresis loop from said best fit functions; and

then

(xiii) evaluating a measure of the domain inside said hysteresis loop.

54. A computer system for assessing cardiac ischemia in a subject to provide a measure of cardiac or cardiovascular health in that subject, said system comprising:

(a) means for providing a first RR-interval data set from said subject during a stage of gradually increasing heart rate;

(b) means for providing a second RR-interval data set from said subject during a stage of gradually decreasing heart rate;

(c) means for comparing said first RR-interval data set to said second RR-interval data set to determine the difference between said data sets; and

(d) means for generating from said comparison of step (c) a measure of cardiac ischemia during stimulation in said subject, wherein a greater difference between said first and second data sets indicates greater cardiac ischemia and lesser cardiac or cardiovascular health in said subject, wherein said generating includes generating an indication of the location of cardiac ischemia in said subject.

55. The system according to claim 54, wherein said generating is carried out by generating curves from each of said data sets.

56. The system according to claim 55, wherein said generating is carried out by comparing the shapes of said curves from data sets.

57. The system according to claim 55, wherein said generating is carried out by determining a measure of the domain between said curves.

58. The system according to claim 55, wherein said generating is carried out by both comparing the shapes of said curves from data sets and determining a measure of the domain between said curves.

60. The product according to claim 59, wherein said generating is carried out by generating curves from each of said data sets.

61. The product according to claim 60, wherein said generating is carried out by comparing the shapes of said curves from data sets.

62. The product according to claim 60, wherein said generating is carried out by determining a measure of the domain between said curves.

63. The product according to claim 60, wherein said generating is carried out by both comparing the shapes of said curves from data sets and determining a measure of the domain between said curves.

59. A computer program product for assessing cardiac ischemia in a subject to provide a measure of cardiac or cardiovascular health in that subject, said computer program product comprising a computer usable storage medium having computer readable program code means embodied in the medium, the computer readable program code means comprising:

(a) computer readable program code means for comparing a first RR-interval data set to a second RR-interval data set to determine the difference between said data sets; and

b) computer readable program code means for generating from said comparing of step (a) a measure of cardiac ischemia during stimulation in said subject, wherein a greater difference between said first and second data sets indicates greater cardiac ischemia and lesser cardiac or cardiovascular health in said subject, wherein said generating includes generating an indication of the location of cardiac ischemia in said subject.