Method and system or managing ECGs in a clinical trial

• US 7,643,870 B2
• Filed: 01/02/2007
• Issued: 01/05/2010
• Est. Priority Date: 01/02/2007
• Status: Expired due to Fees

• Current Assignee: General Electric Company
• Original Assignee: General Electric Company
• Inventors: Kohls, Mark
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US11/619,056
• Publication Number:
  US 20080161704A1
• Time in Patent Office: 1,099 Days
• Field of Search: 600508-523
• US Class Current: 600/509
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/36 Detecting PQ interval, PR interval or QT interval
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires

Abstract

The present disclosure includes a method and system for managing ECGs in a clinical trial including a processor, storage media, ECG acquisition system, user interface device, and the appropriate databases configured to collect and store a set of trial specific drug ECG recordings. The system and method allows a trial administrator to select a set of placebo ECG recordings and a set of known QT prolonged ECG recordings from databases and adjust these sets according to the parameters of the study. Interpretations are made on this superset of ECG recordings and the interpretation is outputted to a user.

Claims

1. A method of managing an ECG clinical trial, the method comprising:

collecting a set of trial specific drug ECG recordings from a patient;

selecting a set of placebo ECG recordings and a set of known QT prolonged ECG recordings;

adjusting the set of placebo ECG recordings and the set of known QT prolonged ECG recordings based on a predetermined set of demographic study parameters;

making an interpretation based on an analysis of the set of trial specific drug ECG recordings, the set of placebo ECG recordings and the set of known QT prolonged ECG recordings; and

outputting the interpretation to a user.

2. The method as claimed in claim 1, further comprising storing the set of trial specific drug ECG recordings in a trial specific drug ECG database.

3. The method as claimed in claim 2, further comprising retrieving the set of trial specific drug ECG recordings form the trial specific drug ECG database before making the interpretation.

4. The method as claimed in claim 1, wherein the set of placebo ECG recordings are selected from a placebo ECG database.

5. The method as claimed in claim 1, wherein the set of known QT prolonged ECG recordings are selected from a known QT prolonged ECG database.

6. The method as claimed in claim 1, wherein the step of selecting the set of known QT prolonged ECG recordings further includes sorting a collection of known QT prolonged ECG recordings according to a T-wave state.

7. The method as claimed in claim 1, wherein the set of known QT prolonged ECG recordings are based on a response to Moxifloxacin.

8. The method of claim 1, further comprising maintaining a log of the selected set of placebo ECG recordings and the selected set of known QT prolonged ECG recordings.

9. The method as claimed in claim 1, wherein the selecting step and the step of making the interpretation are made using a user interface device.

10. A system for managing an ECG trial, the system comprising:

an ECG acquisition device configured to collect a set of trial specific drug ECG recordings from a patient;

a placebo ECG database configured to store placebo ECG database recordings, the placebo ECG database further configured such that a user can select a set of placebo ECG recordings;

a known QT prolonged ECG database configured to store known QT prolonged ECG recordings, the known QT prolonged database further configured such that a user can select a set of known QT prolonged ECG recordings, wherein the set of placebo ECG recordings and the set of known QT prolonged ECG recordings are adjusted based on a predetermined set of demographic study parameters, and further wherein a reader makes an interpretation based on an analysis of the set of trial specific drug ECG recordings, the set of placebo ECG recordings, and the known QT prolonged ECG recordings; and

a user interface device configured to receive the interpretation from the reader.

11. The system as claimed in claim 10, further comprising a trial specific database configured to store the set of trial specific drug ECG recordings.

12. The system as claimed in claim 11, wherein the set of trial specific drug ECG recordings are retrieved form the trial specific drug ECG database before the interpretation is made.

13. The system as claimed in claim 10, wherein the known QT prolonged ECG database is configured to sort the known QT prolonged ECG recordings according to a T-wave state.

14. The system as claimed in claim 10, wherein the set of known QT prolonged ECG recordings are based on a response to Moxifloxacin.

15. The system as claimed in claim 10, further comprising maintaining a log of the selected set of placebo ECG recordings and the selected set of known QT prolonged ECG recordings.

16. The system as claimed in claim 10, wherein the set of placebo ECG recordings and the set of known QT prolonged ECG recordings may be adjusted to any of the parameters:

subject ID number;

recording date;

recording time;

visit number;

recording device serial number;

location; and

study.

17. A system for managing an ECG clinical trial, the system comprising:

an ECG acquisition system configured to collect a set of trial specific drug recordings from a patient;

a storage media storing a computer application;

a processor coupled to an ECG acquisition system and the storage media, and configured to execute the computer application,

wherein when the computer application is executed a set of placebo ECG recordings and a set of known QT prolonged ECG recordings are selected, the set of placebo ECG recordings and the set of known QT prolonged ECG recordings are adjusted based on a predetermined set of demographic study parameters, an interpretation is made based on an analysis of the set of trial specific drug ECG recordings, the set of placebo ECG recordings and the set of known QT prolonged ECG recordings, and the interpretation is outputted to a user.