Method and system for evaluating cardiac ischemia

• US 6,361,503 B1
• Filed: 06/26/2000
• Issued: 03/26/2002
• Est. Priority Date: 06/26/2000
• Status: Expired due to Fees

• Current Assignee: Mediwave Star Technology Incorporated
• Original Assignee: Mediwave Star Technology Incorporated
• Inventors: Starobin, Joseph M., Chernyak, Yuri B.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/603,286
• Time in Patent Office: 638 Days
• Field of Search: 600/508, 600/509, 600/515, 600/516, 600/510, 600/518
• US Class Current: 600/508
• 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 cardiovascular health in that subject is described herein. The method comprises the steps of: (a) collecting a first QT- and 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 QT- and 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 QT- and RR-interval data set to the second QT- and 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 cardiovascular health in the subject. The data sets are collected in such a manner that they reflect almost exclusively the conduction in the heart muscle and minimize rapid transients due to autonomic nervous system and hormonal control on the data sets.

Claims

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

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

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

(c) comparing said first QT- and RR-interval data set to said second QT- and 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 said difference between said first and second data sets indicates greater cardiac ischemia and lesser cardiovascular health in said subject.

2. A method according to claim 1, comprising collecting said first and second QT- and RR-interval data sets under quasi-stationary conditions.

3. A 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. A 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. A 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. A 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. A method according to claim 1, comprising gradually decreasing said heart rate at at least three different heart-rate stimulation levels.

8. A method according to claim 7, comprising gradually increasing said heart rate at at least three different heart-rate stimulation levels.

9. A method according to claim 1, comprising gradually increasing said heart rate and gradually decreasing said heart rate sequentially in time.

10. A method according to claim 1, comprising gradually increasing said heart rate and gradually decreasing said heart rate separately in time.

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

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

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

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

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

16. A method according to claim 1, wherein said heart rate during said stage of gradually increasing heart rate does not exceed more than 120 beats per minute.

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

18. A 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 cardiovascular health for said subject.

19. A 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. A 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. A method according to claim 18, further comprising the step of assessing the likelihood that said subject is at risk to experience a future cardiac incident from said quantitative indicium.

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

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

(c) comparing said first QT- and RR-interval data set to said second QT- and 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 said difference between said first and second data sets indicates greater cardiac ischemia and lesser cardiovascular health in said subject.

23. A 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. A 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. A 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. A 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. A method according to claim 22, comprising gradually decreasing said exercise load at at least three different load levels.

28. A method according to claim 22, comprising gradually increasing said exercise load at least three different load levels.

29. A method according to claim 22, comprising gradually increasing said exercise load and gradually decreasing said exercise load sequentially in time.

30. A method according to claim 22, comprising gradually increasing said exercise load and gradually decreasing said exercise load separately in time.

31. A method according to claim 22, comprising generating curves from each of said data sets.

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

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

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

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

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

38. A 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 cardiovascular health for said subject.

39. A 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 health in said subject from said cardiovascular therapy.

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

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

(a) collecting a first QT- and RR-interval data set from said subject during a stage of gradually increasing exercise load and gradually increasing heart rate at least 5 minutes in duration, and at at least three different load levels; and

then, without an intervening rest stage,

(b) collecting a second QT- and RR-interval data set from said subject during a stage of gradually decreasing exercise load and gradually decreasing heart rate at least 5 minutes in duration, and at at least three different load levels;

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

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

(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 cardiovascular health for said subject.

43. A method according to claim 42, 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.

44. A method according to claim 42, 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.

45. A method according to claim 44, 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.

46. A method according to claim 42, comprising gradually increasing said exercise load and gradually decreasing said exercise load sequentially and contiguously in time.

47. A method according to claim 42, comprising gradually increasing said exercise load and gradually decreasing said exercise load separately in time.

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

49. A method according to claim 48, wherein said generating step is carried out by comparing the shapes of said curves from said data sets.

50. A method according to claim 48, wherein said generating step is carried out by determining a measure of a domain between said curves.

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

52. A method according to claim 48, further comprising the step of displaying said curves.

53. A method according to claim 42, wherein said heart rate during said stage of gradually increasing exercise load does not exceed more than 120 beats per minute.

54. A method according to claim 42, wherein said heart rate during said stage of gradually increasing heart rate exceeds 120 beats per minute.

55. A method according to claim 42, 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.

56. A method according to claim 55, 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.

57. A method according to claim 42, further comprising the step of assessing the likelihood that said subject is at risk to experience a future cardiac incident from said quantitative indicium.

58. A method of assessing cardiac ischemia in a subject to provide a measure of cardiovascular health in said subject during stimulation in said subject, said method comprising the steps of:

(a) collecting a first QT- and RR-interval data set from said subject during a stage of gradually increasing heart rate, said heart rate being gradually increased in response to actual heart rate data collected from concurrent monitoring of said patient;

(b) collecting a second QT- and RR-interval data set from said subject during a stage of gradually decreasing heart rate, said heart rate being gradually decreased in response to actual heart rate data collected from concurrent monitoring of said patient;

(c) comparing said first QT- and RR-interval data set to said second QT- and 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 said difference between said first and second data sets indicates greater cardiac ischemia and lesser cardiovascular health in said subject.

59. A method according to claim 58, wherein said first and second QT- and RR-interval data sets are collected without an intervening rest period.

60. A method according to claim 58, wherein said stage of gradually increasing heart rate and gradually decreasing heart rate are each at least 3 minutes in duration.

61. A method according to claim 58, 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.

62. A method according to claim 58, 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 substantially the same.

63. A method according to claim 62, wherein:

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

64. A method according to claim 58, comprising gradually decreasing said heart rate at at least three different heart-rate stimulation levels.

65. A method according to claim 64, comprising gradually increasing said heart rate at at least three different heart-rate stimulation levels.

66. A method according to claim 58, comprising gradually increasing said heart rate and gradually decreasing said heart rate sequentially in time.

67. A method according to claim 58, comprising gradually increasing heart rate and gradually decreasing said heart rate separately in time.

68. A method according to claim 58, wherein said generating step is carried out by generating curves from each of said data sets.

69. A method according to claim 68, wherein said generating step is carried out by comparing the shapes of said curves from said data sets.

70. A method according to claim 68, wherein said generating step is carried out by determining a measure of a domain between said curves.

71. A method according to claim 68, wherein said generating step is carried out by both comparing the shapes of said curves from said data sets and determining a measure of a domain between said curves.

72. A method according to claim 68, further comprising the step of displaying said curves.

73. A method according to claim 58, wherein said heart rate during said stage of gradually increasing heart rate does not exceed more than 120 beats per minute.

74. A method according to claim 58, wherein said heart rate during said stage of gradually increasing heart rate exceeds 120 beats per minute.

75. A method according to claim 58, 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 cardiovascular health for said subject.

76. A method according to claim 75, 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.

77. A method according to claim 76, 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.

78. A method according to claim 75, further comprising the step of assessing the likelihood that said subject is at risk to experience a future cardiac incident from said quantitative indicium.