|Guideline of the JTpeak Initiative for the ISCE 2017 meeting|
The end of the QRS (J-point) to peak of the T-wave JTpeak interval is a sub-interval of the QT interval from the body-surface ECG that has gained attention over the past years in the field of drug safety assessment. The interest for the drug-effect on the JTpeak interval has spawned an increasing number of scientific investigations specifically in the field of regulatory sciences and, more specifically in the context of the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative. The JTpeak interval relies on fiducial points that are usually included in ECG analysis algorithm: QRS offset and T-wave apex. The JT interval has historically not been reported as an ECG marker in clinical practice and therefore there is lack of information about the automatic JTpeak measurements, its dependency to heart rate, the impact of the lead selection and T-wave morphology, the technical and electrophysiological expected variability and its level of regulation by the autonomic nervous system.
The International Society for Computerized Electrocardiology organized a Special Session during its yearly scientific meeting around the JTpeak interval measurement and proposes to private and academic investigators to study the JTpeak intervals with their proprietary or non-proprietary methods in a set of standard 12-lead ECGs acquired in a drug study conducted by the FDA.
The objective of the session is to give an opportunity to investigators interested in this field to present the outcome of their automatic algorithm for JTpeak measurements in healthy subjects at baseline and when these individuals are exposed to a set of drugs with different profiles (single and multi-ion current inhibitors). The investigators can download a set of recordings in Physionet or ISHNE format and will be expected to produce a set of results in a pre-defined format. These results will be then processed using a standard report system developed at the FDA, and the resulst will be presented during the ISCE session. The dataset is fully open (no blinding) and information about the ECG recordings association to the study design characteristics, i.e., baseline or drug arm, time point and subject ID are freely available.
Overall the proposed set of data includes: 5,232 files (2x for physionet format) recorded in a randomized controlled five-way single-dose crossover clinical trial in 22 healthy volunteers (11 females). The drugs evaluated in this study were dofetilide (Pfizer, New York, NY), quinidine sulfate (Watson Pharma, Corona, CA), ranolazine (Gilead, Foster City, CA), and verapamil hydrochloride (Heritage Pharmaceuticals, Edison, NJ). This dataset includes only 10-sec standard 12-lead ECGs.
Investigators participation and requirements:
The registration is free and any organization is invited to participate to this initiative. The only requirement for participation is to register to the initiative through the THEW Registration system provided below. The participation to the initiative will be considered complete the day the final result file is uploaded to the THEW submission website and the format of the CSV file containing the results is approved.
The deadline for submission is February 28th, 2017.
One single upload will be permitted. Submission past this deadline will not be accepted.
The results will be presented on 04/20/2017 during the ISCE annual meeting to be held at:
The King and Prince Beach & Golf Resort
201 Arnold Road
St. Simons Island, Georgia 31522
It is planned to have 3 presentations from 3 investigators and one final presentation from the initiative organizers during the session. Participants to the session will be selected by an independent committee of experts. The three presenting investigators will be invited to share their results as they see fit. The last presentation of the session will summarize the results from all participants.
Below are the step-by-step description of the registration process for the JTpeak Initiative. Any question should be directed to Mr. Connor Besaw @ Connor.Besaw@heart.rochester.edu.
|Step-by-step registration and guidelines for contributing to the ISCE 2017 JTpeak Initiative:|
Step 1: Register and download the data
Go to THEW website for registration at: https://redcap.urmc.rochester.edu/redcap/surveys/?s=LP3DRHT9NP
Step 2: Process the ECG files
Apply your ECG algorithm to automatically measure the JTpeak intervals from the standard 12-lead ECGs. Three specific lead s are required: lead II, lead V5, and vector magnitude lead (defined as the RMS lead computed from reconstructed orthogonal X, Y, and Z leads). Measurements from other leads can be added tot he result files.
Step 3: Upload your results
Please upload your CSV files into the THEW submission website. The link to this website will be sent by email after your registration is completed and processed. Your final results should be saved in a CSV file to be uploaded using the link you received after registering to the initiative.
|TABLE: Description of the information to include in the CSV file of the results to be submitted.|
|Method details||Description||Field name|
|ECG file||ECG Identification:||ECGID|
|Heart rate||RR interval||RR|
|Lead selection||Standard leads:|
|Vector Magnitude lead (required)*||JT_VM|
|Beat Selection||Lead Flag value:||BS_FLAG|
|Median beat (using provided median signal)||1|
|Median beat (using your own compution)||2|
|Non-Median beat (RAW signal)||3|