Method and system for processing electrocardiograms

• US 7,654,965 B2
• Filed: 06/09/2006
• Issued: 02/02/2010
• 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): Evanisko; George R
• Assistant Examiner(s): HAYES, ANDREW L
• Application Number:
  US11/423,255
• Publication Number:
  US 20060217623A1
• Time in Patent Office: 1,334 Days
• Field of Search: None
• US Class Current: 600/508
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof

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. An ECG processing management system for processing electrocardiograms (ECGs), comprising:

means for receiving protocol data for a first clinical trial;

means for receiving and storing ECG data for a plurality of ECGs associated with the first clinical trial;

means for processing said ECGs to receive interval measurements for said ECGs;

means for processing said ECGs after measurement to receive a cardiological evaluation for each of said ECGs;

means for receiving protocol data for a second clinical trial for use with said ECGs associated with the first clinical trial, and for receiving modified protocol data for said first clinical trial; and

means for identifying ECGs from said plurality of ECGs associated with the first clinical trial that require re-measurement and reevaluation based on said protocol data for the second clinical trial and modified protocol data for said first clinical trial,

wherein ECGs identified by the identifying means to require re-measurement and reevaluation are automatically reprocessed by said means for processing said ECGs to receive interval measurements and said means for processing said ECGs after measurement to receive a cardiological evaluation as needed to comply with the protocol data for the second clinical trial or modified protocol data for the first clinical trial.

2. The ECG processing management system of claim 1, further comprising:

means for receiving ECO data for a second plurality of ECGs for evaluation after receipt of said protocol data for the second clinical trial; and

means processing said second plurality of ECGs in parallel to obtain interval measurements and cardiac evaluations in accordance with said protocol data for said first clinical trial and said protocol data for said second clinical trial.

3. The ECG processing management system of claim 1, further comprising:

means for receiving modified demographic data associated with said ECG data for at least one of the plurality of ECGs;

means for comparing said modified demographic data against protocol data to determine if said ECG requires re-measurement and reevaluation.

4. The ECG processing management system of claim 1, further comprising:

means for automatically generating a report relating to evaluations of said ECGs.

5. The ECG processing management system of claim 1, wherein said means for receiving protocol data for said first clinical trial identifies a sponsor of said first clinical trial, retrieves a protocol template associated with said sponsor and customizes said protocol template for said first clinical trial.

6. The ECG processing management system of claim 1, further comprising means for determining if additional demographic or patient data is required for said ECGs based on said protocol data for the second clinical trial and modified protocol data for said first clinical trial, wherein ECGs for which it is determined additional demographic or patient data is required are made available to means for processing said ECGs to obtain said additional demographic or patient data.

7. A computer-implemented method of processing electrocardiograms (ECGs), comprising the steps of:

receiving into an ECG processing management system protocol data for a first clinical trial;

receiving and storing into the ECG processing management system ECG data for a plurality of ECGs associated with the first clinical trial;

processing the ECGs with the ECG processing management system to receive interval measurements for the ECGs;

after receiving interval measurements of the ECGs, processing the ECGs with the ECG processing management system to receive a cardiological evaluation for each of the ECGs;

receiving into the ECG processing management system protocol data for a second clinical trial for use with the ECGs associated with the first clinical trial;

receiving into the ECG processing management system modified protocol data for the first clinical trial; and

identifying with the ECG processing management system ECGs from the plurality of ECGs associated with the first clinical trial that require re-measurement and reevaluation based on the protocol data for the second clinical trial and modified protocol data for the first clinical trial,

wherein ECGs identified by the identifying step to require re-measurement and reevaluation are automatically reprocessed with the ECG processing management system to receive interval measurements and to receive a cardiological evaluation as needed to comply with the protocol data for the second clinical trial or modified protocol data for the first clinical trial.

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

receiving ECG data for a second plurality of ECGs for evaluation after receipt of the protocol data for the second clinical trial; and

processing the second plurality of ECGs in parallel to obtain interval measurements and cardiac evaluations in accordance with the protocol data for the first clinical trial and the protocol data for the second clinical trial.

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

receiving modified demographic data associated with the ECG data for at least one of the plurality of ECGs;

comparing with the ECG processing management system the modified demographic data against protocol data to determine if the ECG requires re-measurement and reevaluation.

10. The method of claim 7, further comprising the step of automatically generating with the ECG processing management system a report relating to evaluations of the ECGs.

11. The method of claim 7, wherein the step of receiving in the ECG processing management system protocol data for the first clinical trial includes the steps of identifying a sponsor of the first clinical trial, retrieving a protocol template associated with the sponsor and customizing the protocol template for the first clinical trial.

12. The method of claim 7, further comprising the step of determining with the ECG processing management system if additional demographic or patient data is required for the ECGs based on the protocol data for the second clinical trial and modified protocol data for the first clinical trial, and processing ECGs for which it is determined additional demographic or patient data is required to obtain the additional demographic or patient data.