Method and system for processing electrocardiograms

• US 6,708,057 B2
• Filed: 01/10/2002
• Issued: 03/16/2004
• Est. Priority Date: 11/20/2001
• Status: Expired due to Term

• Current Assignee: E Research Technology, Inc.
• Original Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Inventors: Morganroth, Joel
• Primary Examiner(s): Layno, Carl
• Application Number:
  US10/045,843
• Publication Number:
  US 20030097077A1
• Time in Patent Office: 796 Days
• Field of Search: 600/509, 600/515, 600/516, 600/523, 600/525, 128/903, 607/32, 607/60
• US Class Current: 600/509
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 30/40 for processing medical images, e.g. editing
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

In a method and system for processing an electrocardiogram (ECG), digital ECG data are received. The digital ECG data evinces a plurality of a patient'"'"'s heartbeats detected during an ECG. Digital annotation data are generated representing marking to be shown on an ECG tracing of the plurality of heartbeats. An annotated ECG tracing image is produced using the digital ECG data and the digital annotation data.

Claims

1. A method of processing an electrocardiogram (ECG), comprising the steps of:

receiving digital ECG data, said digital ECG data evincing a plurality of a patient'"'"'s heartbeats detected during an ECG;

generating digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of said plurality of heartbeats;

generating digital interval duration data representing a time duration of an interval associated with an interval duration measurement, said generating step including the steps of;

displaying said ECG tracing image of said plurality of heartbeats on a display of a user terminal;

identifying endpoints of said interval; and

determining said time duration of a measured interval based at least in part on said identified endpoints, wherein said markings identify at least one heartbeat from said plurality of heartbeats associated with said interval duration measurement; and

developing an annotated ECG tracing image using said digital ECG data and said digital annotation data.

2. The method of claim 1, wherein the step of developing said annotated ECG tracing image includes the step of displaying said annotated ECG tracing imago on a display of a user terminal.

3. The method of claim 1, wherein said markings identify said endpoints.

4. The method of claim 1, wherein said markings further identify a time duration of said measured interval.

5. The method of claim 1, wherein said digital ECG data evince an image of an ECG tracing.

6. The method of claim 1, further comprising the step of receiving digital demographic data associated with said patient and said ECG.

7. The method of claim 1, further comprising the steps of:

displaying said annotated ECG image on a display of a user terminal to an evaluating physician;

providing said evaluating physician with interval duration data, said interval duration data developed from said digital interval duration data; and

receiving digital evaluation data representing a medical evaluation of said ECG by said evaluating physician.

8. The method of claim 7, wherein said digital evaluation data are received by a computer processor unit through a computer network from a user terminal remote from said computer processor unit.

9. The method of claim 7, further comprising the steps of:

displaying a second annotated ECG image on a display of a user terminal to said evaluating physician, said second annotated ECG image being associated with a prior ECG of said patient; and

providing said evaluating physician interval duration data and evaluation data associated with said second annotated ECG image, said interval duration data and evaluation data being developed from digital interval duration data and digital evaluation data.

10. The method of claim 7, wherein digital evaluation data are received for a plurality of ECGs for a plurality of patients within a clinical study, the method further comprising the step of:

automatically identifying at least one ECG from said plurality of ECGs for quality review based at least in part on digital evaluation data or digital interval duration data associated with said plurality of ECGs.

11. The method of claim 7, wherein digital evaluation data are received for a plurality of ECGs for a plurality of patients within a clinical study, the method further comprising the steps of:

automatically generating a report for at least one ECG from said plurality of ECGs, said report including evaluation data developed from digital evaluation data associated with said at least one ECG from said plurality of ECGs; and

automatically providing said report to a party identified by digital reporting criteria for said clinical study and in a manner identified by said digital reporting criteria.

12. The method of claim 1, wherein said digital ECG data and digital annotation data are provided to a regulatory agency processor through a computer network from a computer processor unit remote from said regulatory agency processor.

13. The method of claim 12, wherein said computer network is the Internet.

14. An electrocardiogram (ECG) processing system, comprising:

at least one processor, said at least one processor configured to;

generate digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of a plurality of a patient'"'"'s heartbeats detected during art ECG, wherein said marking identify at least one heartbeat from said plurality of heartbeats associated with an interval duration measurement;

generate digital interval duration data, said digital interval duration data representing a time duration of an interval associated with said interval duration measurement;

display said ECG tracing image on a display;

receive endpoint data representing identified endpoints of said interval;

generate said digital interval duration data at least in part from said endpoint data; and

develop an annotated ECG tracing image using said digital annotation data and digital ECG data, said digital ECG data evincing said plurality of a patient'"'"'s heartbeats.

15. The system of claim 14, further comprising:

at least one receiving station for receiving said digital ECG data from at least one ECG machine,

said at least one processor being further configured to receive said digital ECG data from said receiving station.

16.The system of claim 15, wherein;

said receiving station receives digital demographic data associated with said patient and said ECG, and

said at least one processor is configured to receive said digital demographic data from said receiving station.

16. The system of claim 14, further comprising a display for displaying said annotated ECG tracing image.

17. The system of claim 14, wherein said markings identify said endpoints.

19. The system of claim 14, comprising a display for displaying said annotated ECG image to an evaluating physician and for displaying interval duration data developed from said digital interval duration data,

said at least one processor further configured to receive digital evaluation data representing a medical evaluation of said ECG by said evaluating physician.

25. The system of claim 14, wherein said at least one processor is configured to provide said digital ECG data and digital annotation data to a regulatory agency processor remote from said at least one processor through a computer network.

18. The system of claim 18, wherein said marking further identify a time duration of said measured interval.

20. The system of claim 20, further comprising a Computer processor unit remote from said at least one processor for providing said digital evaluation data to said at least one processor unit through a computer network.

22. The system of claim 20,

wherein a second annotated ECG image is displayed to said evaluating physician on said display, said second annotated ECG image being associated with a prior ECG of said patient and

wherein said at least one processor is configured to provide interval duration data and evaluation data associated with said second annotated ECG image to said evaluating physician on said display.

23. The system of claim 20, wherein digital evaluation data are received by said at least one processor for a plurality of ECGs for a plurality of patients within a clinical study, said at least one processor automatically identifies at least one ECG from said plurality of ECGs for quality review based at least in part on digital evaluation data or digital interval duration data associated with said plurality of ECGs.

24. The system of claim 20, wherein:

digital evaluation data are received by said at least one processor for a plurality of ECGs for a plurality of patients within a clinical study, and

said at least one processor is configured to;

automatically generate a report for at least one ECG from said plurality of ECGs, said report including evaluation data developed from digital evaluation data received for said at least one ECG; and

automatically provide said report to a party identified by digital reporting criteria for said clinical study and in a manner identified by said digital reporting data.

21. The system of claim 21, wherein said computer network is the Internet.

26. A method of processing an electrocardiogram (ECG), comprising the steps of:

receiving digital parameter data clinical study, digital parameter data representing demographic data to be collected for ECGs associated with said clinical study, rules

associated with said clinical study and query resolution contact information;

receiving digital demographic data evincing demographic data for an ECG associated with said clinical study; and

automatically generating a query in accordance with said query resolution contact information if a problem is identified with said demographic data based upon said digital parameter data.

27. The method of claim 27, wherein said step of automatically generating said query includes the step of identifying whether demographic data are missing, said demographic data violate a rule associated with said clinical study, said demographic data are inconsistent with demographic data evinced by digital demographic data received for a second ECG associated with said clinical study, or a combination thereof.

28. The method of claim 27, wherein said query resolution contact information includes an identification of a party to be contacted and a contact method.

29. The method of claim 27, further comprising the steps of:

displaying an ECG image on a display of a user terminal to an evaluating physician, said ECG image developed from digital ECG data, said digital ECG data evincing a plurality of a patient'"'"'s heartbeats detected during an ECG;

providing said evaluating physician with interval duration data, said interval duration data developed from digital interval duration data representing a time duration of a measured interval associated with at least one heartbeat from said plurality of heartbeats; and

receiving digital evaluation data representing a medical evaluation of said ECG by said evaluating physician.

30. The method of claim 30, wherein said digital evaluation data are received by a computer processor unit through a computer network from a user terminal remote from said computer processor unit.

31. The method of claim 30, further comprising the steps of:

displaying a second annotated ECG image on a display of a user terminal to said evaluating physician, said second annotated ECG image being associated with a prior ECG of said patient; and

providing said evaluating physician interval duration data and evaluation data associated with said second annotated ECG image, said interval duration data and evaluation data being developed from digital interval duration data and digital evaluation data.

32. The method of claim 30,

wherein said digital parameter data represent quality review rules, and

wherein digital evaluation data are received for a plurality of ECGs for a plurality of patients within said clinical study, the method further comprising the step of:

automatically identifying at least one ECG from said plurality of ECGs for quality review based at least in part on said digital parameter data.

34. The method of claim 30,

wherein said digital parameter data represent reporting rules, and

wherein digital evaluation data are received for a plurality of ECGs for a plurality of patients within said clinical study, the method further comprising the steps of:

automatically generating a report for at least one ECG from said plurality of ECGs, said report including evaluation data developed from respective digital evaluation data for said at least one ECG; and

automatically providing said report to a party identified by said digital parameter data for said clinical study and in a manner identified by said digital parameter data.

33. The method of claim 33, wherein said automatically identifying step includes the step of identifying at least one ECG for quality review based at least in part on digital evaluation data received for said plurality of ECGs or digital interval duration data associated with said plurality of ECGs.

35. An electrocardiogram (ECG) processing system, comprising:

at least one processor, said at least one processor configured to;

receive digital parameter data for a clinical study, said digital parameter data representing demographic data to be collected for ECGs associated with said clinical study, rules associated with said clinical study and query resolution contact information;

receive digital demographic data evincing demographic data for an ECG associated with said clinical study; and

automatically generate a query in accordance with said query resolution contact information if a problem is identified with said demographic data based upon said digital parameter data.

36. The system of claim 36, wherein said at least one processor is configured to automatically generate said query by identifying whether demographic data are missing, said demographic data violate a rule associated with said clinical study, said demographic data are inconsistent with demographic data evinced by digital demographic data received for a second ECG associated with said clinical study, or a combination thereof.

37. The system of claim 36, wherein said query resolution contact information includes an identification of a party to be contacted and a contact method.

38. The system of claim 36, further comprising:

a display for displaying an ECG image to an evaluating physician, said ECG image developed from digital ECG data, said digital ECG data evincing a plurality of a patient'"'"'s heartbeats detected during an ECG, and for displaying interval duration data, said interval duration data developed from digital interval duration data representing a time duration of a measured interval associated with at least one heartbeat from said plurality of heartbeats,

wherein said at least one processor is configured to receives digital evaluation data representing a medical evaluation of said ECG by said evaluating physician.

39. The system of claim 39, wherein said digital evaluation data are received through a computer network from a user terminal remote from said at least one processor.

40. The system of claim 39,

wherein said display displays a second annotated ECG image to said evaluating physician, said second annotated ECG image being associated with a prior ECG, and

wherein said at least one processor is configured to provide interval duration data and evaluation data associated with said second annotated ECG image to said display for display to said evaluating physician.

41. The system of claim 39,

wherein said digital parameter data represent quality review rules,

wherein said digital evaluation data are received by said at least one processor for a plurality of ECGs for a plurality of patients within said clinical study, and

wherein said at least one processor is configured to automatically identify at least one ECG from said plurality of ECGs for quality review based at least in part on said digital parameter data.

43. The system of claim 39,

wherein said digital parameter data represent reporting rules, and

wherein said digital evaluation data are received for a plurality of ECGs for a plurality of patients within said clinical study,

said at least one processor being further configured to:

automatically generate a report for at least one ECG from said plurality of ECGs, said report including evaluation data developed from respective digital evaluation data for said at least one ECG, and

automatically provide said report to a parry identified by said digital parameter data for said clinical study and in a manner identified by said digital parameter data.

42. The system of claim 42, wherein said at least one processor is configured to automatically identify said at least one FCC based at least in part on digital evaluation data received for said plurality of ECGs or digital interval duration data associated with said plurality of ECGs.

44. A method of processing an electrocardiogram, comprising the a steps of:

receiving digital ECG data, said digital ECG data evincing a plurality of a patient'"'"'s heartbeats detected during an ECG;

generating digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of said plurality of heartbeats;

developing an annotated ECG tracing image using said digital ECG data and said digital annotation data;

displaying said annotated ECG image on a display of a user terminal to an evaluating physician;

providing said evaluating physician with interval duration data, said interval duration data developed from digital interval duration data representing a time duration of a measured interval associated with at least one heartbeat from said plurality of heartbeats; and

receiving digital evaluation data representing a medical evaluation of said ECG by said evaluating physician,

wherein digital evaluation data are received for a plurality of ECGs for a plurality of patients within a clinical study, the method further comprising the step of;

automatically identifying at least one ECG from said plurality of ECGs for quality review based at least in part on digital evaluation data or digital interval duration data associated with said plurality of ECGs.

45. A method of processing an electrocardiogram, comprising the steps of:

receiving digital ECG data, said digital ECG data evincing a plurality of a patient'"'"'s heartbeats detected during an ECG;

generating digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of said plurality of heartbeats;

developing an annotated ECG tracing image using said digital ECG data and said digital annotation data;

displaying said annotated ECG image on a display of a user terminal to an evaluating physician;

providing said evaluating physician with interval duration data, said interval duration data developed from digital interval duration data representing a time duration of a measured interval associated with at least one heartbeat from said plurality of heartbeats; and

receiving digital evaluation data representing a medical evaluation of said ECG by said evaluating physician,

wherein digital evaluation data are received for a plurality of ECGs for a plurality of patients within a clinical study, the method further comprising the steps of;

automatically generating a report for at least one ECG from said plurality of ECGs, said report including evaluation data developed from digital evaluation data associated wit said at least one ECG from said plurality of ECGs; and

automatically providing said report to a party identified by digital reporting criteria for said clinical study and in a manner identified by said digital reporting criteria.

46. A method of processing an electrocardiogram (ECG), comprising the steps of:

receiving digital ECG data, said digital ECG data evincing a plurality of a patient'"'"'s heartbeats detected during an ECG;

generating digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of said plurality of heartbeats; and

developing an annotated ECG tracing image using said digital ECG data and said digital annotation data,

wherein said digital ECG data and digital annotation data are provided to a regulatory agency processor through a computer network from a computer processor unit remote from said regulatory agency processor.

47. The method of claim 47, wherein said computer network is the Internet.

48. An electrocardiogram (ECG) processing system, comprising:

at least one processor, said at least one processor configured to;

generate digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of a plurality of a patient'"'"'s heartbeats detected during and ECG; and

develop an annotated ECG tracing image using said digital annotation data and digital ECG data, said digital ECG data evincing said plurality of a patient'"'"'s heartbeats; and

a display for displaying said annotated ECG image to an evaluating physician and for displaying interval duration data developed item digital interval duration data representing a time duration of a measured interval associated with at least one heartbeat from said plurality of heartbeats,

said at least one processor further configured to receive digital evaluation data representing a medical evaluation of said ECG by said evaluating physician,

wherein digital evaluation data are received by said at least one processor for a plurality of ECGs for a plurality of patients within a clinical study, said at least one processor further configured to automatically identify at least one ECG from said plurality of ECGs for quality review based at least in part on digital evaluation data or digital interval duration data associated with said plurality of ECGs.

49. An electrocardiogram (ECG) processing system, comprising:

at least one processor, said at least one processor configured to;

generate digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of a plurality of a patient'"'"'s heartbeats detected during and ECG; and

develop an annotated ECG tracing image using said digital annotation data and digital ECG data, said digital ECG data evincing said plurality of a patient'"'"'s heartbeats; and

a display for displaying said annotated ECG image to an evaluating physician and for displaying interval duration data developed from digital interval duration data representing a time duration of a measured interval associated with at least one heartbeat from said plurality of heartbeats,

said at least one processor further configured to receive digital evaluation data representing a medical evaluation of said ECG by said evaluating physician, wherein;

digital evaluation data are received by said at least one processor for a plurality of ECGs for a plurality of patients within a clinical study, and

said at least one processor is further configured to;

automatically generate a report for at least one ECG from said plurality of ECGs, said report including evaluation data developed from digital evaluation data received for said at least one ECG; and

automatically provide said report to a party identified by digital reporting criteria for said clinical study and in a manner identified by said digital reporting data.

50. An electrocardiogram (ECG) processing system, comprising:

at least one processor, said at least one processor configured to;

generate digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of a plurality of a patient'"'"'s heartbeats detected during an ECG;

develop an annotated ECG tracing image using said digital annotation data and digital ECG data, said digital ECG data evincing said plurality of a patient'"'"'s heartbeats; and

provide said digital ECG data and digital annotation data to a regulatory agency processor remote from said at least one processor through a computer network.

51. The system of claim 51, wherein said computer network is the Internet.

52. An electrocardiogram (ECG) processing system, comprising:

at least one processor, said at least one processor configured to;

generate digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of a plurality of a patient'"'"'s heartbeats detected during an ECG;

develop an annotated ECG tracing image using said digital annotation data and digital ECG data, said digital ECG data evincing said plurality of a patient'"'"'s heartbeats;

receive said digital ECG data from a receiving station; and

receive digital demographic data from said receiving station.

53. The system of claim 53, further comprising at least one receiving station for receiving said digital ECG data from at least one ECG machine.

54. A method of processing an electrocardiogram (ECG), comprising the steps of:

receiving digital ECG data from a receiving station, said digital ECG data evincing a plurality of a patient'"'"'s heartbeats detected during an ECG;

generating digital annotation data, said digital annotation data representing markings to be shown on an ECG tracing image of said plurality of heartbeats;

developing an annotated ECG tracing image using said digital ECG data and said digital annotation date; and

receiving digital demographic data associated with said patient and said ECG from said receiving station.

55. The method of claim 55, wherein said receiving station receives said digital ECG data from at least one ECG machine.