Method and system for evaluating arrhythmia risk with QT-RR interval data sets

• US 7,123,953 B2
• Filed: 12/03/2002
• Issued: 10/17/2006
• Est. Priority Date: 12/26/2001
• Status: Expired due to Fees

• Current Assignee: Mediwave Star Technology Incorporated
• Original Assignee: Mediwave Star Technology Incorporated
• Inventors: Chernyak, Yuri B., Starobin, Joseph M.
• Primary Examiner(s): Pezzuto, Robert E.
• Assistant Examiner(s): Heller, Tammie K.
• Application Number:
  US10/308,821
• Publication Number:
  US 20030130586A1
• Time in Patent Office: 1,414 Days
• Field of Search: 600515-517, 600/519, 600/521
• US Class Current: 600/516
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system

Abstract

A method of assessing the cardiac arrhythmia risk in a subject to provide a measure of cardiac or cardiovascular health in that subject is described herein. In one embodiment, the method comprises the steps of: (a) collecting at least one QT and RR interval data set from the subject; (b) separating fluctuations from slow trends in said at least one QT and RR interval data set; (c) comparing said QT and RR fluctuations to one another and (d) generating from the comparison of step (c) partial measures of risk of cardiac arrhythmia in said subject. A greater difference between QT and RR fluctuations indicates greater risk of cardiac arrhythmia in said subject. The data sets are collected in such a manner that they reflect almost exclusively the conduction in the heart muscle and minimize the effect on the data sets of rapid transients due to autonomic nervous system and hormonal control.

Claims

1. A method of screening for risk of cardiac arrhythmia in a subject, the method comprising the steps of:

(a) collecting at least one QT interval data set and at least one RR interval data set from the subject during (i) a stage of gradually increasing heart rate, (ii) a stage of gradually decreasing heart rate, or (iii) both a stage of gradually increasing heart rate and gradually decreasing heart rate;

(b) separating fluctuations from slow trends in said at least one QT interval data set and in said at least one RR interval data set to provide QT fluctuations and RR fluctuations;

(c) comparing said QT fluctuations and said RR fluctuations to one another to determine the difference therebetween; and

(d) generating from the comparison of step (c) a measure of risk of cardiac arrhythmia in said subject, wherein a greater difference between QT fluctuations and RR fluctuations indicates greater risk of cardiac arrhythmia in said subject.

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

7. The method according to claim 6, wherein said stage of gradually increasing heart rate is carried out at at least three different heart-rate stimulation levels.

8. 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.

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 separately in time.

10. The 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.

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

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

(e) comparing said measure of risk of cardiac arrhythmia risk to at least one reference value; and

then

(f) generating from said comparison of step (e) a quantitative indicium of risk of cardiac arrhythmia for said subject.

13. The method according to claim 12, 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 quantitative indicium from before said therapy to after said therapy indicates an improvement in cardiac health in said subject from said cardiovascular therapy.

14. The method according to claim 13, 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, p harmaceutical treatment, surgical treatment, and combinations thereof.

15. The method according to claim 13, further comprising the step of assessing from said quantitative indicum the likelihood that said subject is at risk to experience a future cardiac arrhythmia.

16. The method according to claim 1, wherein said data sets are collected by:

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

collecting a second QT and RR interval data set from said subject during a stage of gradually decreasing heart rate;

said method further comprising the steps of;

(e) 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

(f) generating from said comparison of step (e) a measure of risk of cardiac arrhythmia in said subject, wherein a greater difference between said first and second data sets indicates greater risk of cardiac arrhythmia in said subject.

17. A method of assessing risk of cardiac arrhythmia in a subject, said method comprising the steps, performed on a computer system, of:

(a) providing at least one QT interval data set and at least one RR interval data set collected from said subject during (i) a stage of gradually increasing heart rate, (ii) a stage of gradually decreasing heart rate, or (iii) both a stage of gradually increasing heart rate and gradually decreasing heart rate;

(b) separating fluctuations from slow trends in said at least one QT interval data set and in said at least one RR interval data set to provide QT fluctuations and RR fluctuations;

(c) comparing said QT fluctuations and said RR fluctuations to one another to determine the difference therebetween; and

(d) generating from the comparison of step (c) a measure of risk of cardiac arrhythmia in said subject, wherein a greater difference between QT fluctuations and RR fluctuations indicates greater risk of cardiac arrhythmia in said subject.