Happy New Year 2010

The THEW Celebrates its First Anniversary

• Editorial
• Two New ECG Databases available in the THEW
• THEW "Beyond QT working Group" releases an ECG marker submission form designed in collaboration with the FDA.
• THEW Educational Program: Four international students completed last Semester 2009
• Profiling the THEW Team: Michal Benita-Weiss, Project Coordinator

"The THEW is fully functional with more than 500GB of continuous ECG recordings from healthy individuals and from cardiac patients."

"The new version of the THEW website provides an improved access to information related to the ECG databases, a section specific to FDA/THEW partnership, and a section for the THEW training program."

Editorial:

We are celebrating the first anniversary of the THEW, and it is the right time to review what we have achieved during year 2009. Certainly the most important milestone has been the support we have received from the National Heart and Lung Blood Institute (NHLBI). The institute allocated significant resources to help us developing the Center for Quantitative Electrocardiography and Cardiac Safety (the organization hosting the THEW). These funds will help us develop our activitites for the next 3 years. In addition, the THEW received an increasing number of requests for data access and for membership. A steadily increasing number of data accesses were granted during the last semester of 2009, and numerous research projects are currently being implemented. Both for-profit and non-for-profit organizations have joined our initiative either by becoming members or by providing data and technologies.

Today, the THEW is fully functional with more than 500GB of continuous ECG recordings available from healthy individuals and from cardiac patients. Data from drug safety studies (thorough QT studies), and clinical studies, as well as data from patients with arrhythmias can be downloaded by our members. Currently, we have scientists from the U.S. and Europe using the data for their research work.

To keep scientists and other profesionals aware of the various activities implemented in our initiative, we have started a LinkedIn group for the Center for Quantitative Electrocardiography and Cardiac Safety. More than 230 individuals have already joined. They receive weekly updates about new members, working group and new database releases. You can freely join this group by visiting our website (LinkedIn group: Center for Quantitative Electrocardiography & Cardiac Safety).

Our objectives for 2010 are multiple: 1) adding large sets of data into the THEW, 2) developing further our educational program, 3) grow the work around collaborative research activities (using our supercomputer resources) and finaly 4) develop activities around our working groups.

In 2009, our webiste was visited by organizations and individuals from 78 different countries and territories. As shown in the figure below, around 70% of visitors are from the USA while ~20% are from European countries. The remaing ~ten percent are from Asia, South America and Australia.

At the end of this month, we will release our new format for the THEW website. This new version will provide an improved access to the information related to the ECG databases, a section specific to FDA/THEW partnership, and a section about the THEW training program. Figure: Percentage distribution of visits from theTHEW website for year 2009.

In this first issue of the newsletter for 2010, you will find a description of the two new databases recently added to the warehouse. Also, information about the work achieved by the "Beyond QT working" group is provided. Finaly, we wrote a couple of paragraphs about the four students from Denmark who have spent a semester in Rochester (NY) to participate to the THEW Educational Program during the Winter of 2009.

We hope you will enjoy the new format of our Newsletter.

Have a happy and successful New Year 2010.

Jean-Philippe Couderc, PhD, MBA

Two New ECG Databases available in the THEW:

The THEW team is glad to announce the release of two novel ECG databases in the THEW including 4GB of continuous ECG recordings from: 1) Cardiac patients with atrial fibrillation; and 2) Recordings of patients with a history of drug-induced torsades de pointes.

New database in the THEW: Cardiac patients with atrial fibrillation.

This database includes ECGs from 73 cardiac patients with atrial fibrillation (database ID: E-OTH-12-73-011). The 12-lead continuous ECG recordings (1000 Hz sampling frequency) are from patients referred for cardioversion (with persistent Afib). Patients were followed for four weeks after cardioversion and were offered ECG if they suffered from symptoms of arrhythmia recurrence at any time during the study. All patients underwent a final ECG evaluation at four weeks post-cardioversion. The ECGs available in the THEW were recorded prior to cardioversion, during a resting period of 10-20 minutes in a quiet room. The list of clinical information for this database includes: history of Afib, presence of coronary artery disease, presence of myocardial infarction, history of hypertension, ejection fraction, and hypokalemia. More information about this database can be found at the following link :E-OTH-12-0073-011.html

Cardiac patients with a history of drug-induced torsades de pointes (TdPs):
These ECGs are from cardiac patients with a history of drug-induced TdPs (database ID: E-OTH-12-68-010).The database includes 68 ECGs recorded from 34 patients. Baseline and on-sotalol ECGs were acquired (12-lead electrocardiogram recorded at 1,000 Hz sampling frequency, 3-4 min long). The patients were enrolled after being admitted to the hospital for documented torsades de pointes (TdPs) in the context of a drug with QT-prolonging potential: sotalol, sumatriptan, amiodarone, bisacodyl, cipramil, furosemide, clarithromycin, erythromycin, roxythromicin. The patients were enrolled for an evaluation of the individual level of repolarization reserve. They were all genetically tested for presence of mutation of the major LQTS genes using standard genotyping techniques (genomic DNA was prepared from lymphocytes, amplification of KCNQ1, KCNH2, KCNE1, KCNE2 and SCN5A using polymerase chain reactions were performed, followed by direct sequencing of these major LQT-disease genes). The control group (N=17) consisted of patients who were started on sotalol for prevention of paroxysmal atrial fibrillation and had given informed consent to enter the study.  More information about this database can be found at the following link E-OTH-12-0068-010.html 

THEW Beyond QT Working Group releases an ECG marker submission form designed in collaboration with the FDA

The "THEW Beyond QT Working Group" has released, in collaboration with FDA regulators, the "Electrocardiographic Marker(s) Submission Form to The Office of Translational Science of the Center for Drug Evaluation and Research, FDA". This form was developed in collaboration with the Associate Director for Operations in Genomics (Dr. Federico Goodsaid) as well as experts and members of the THEW to facilitate the description of the context of use, validations, and any scientific investigations pertaining to novel ECG marker(s).  The type of markers to be submitted are expected to be a characteristic of the electrocardiographic signal measured from the body surface that is objectively measured and evaluated as an indicator of normal electrophysiological processes, pathogenic processes, or pharmacologic responses to a xenobiotic exposure. Such ECG markers can be used in clinical practice to identify risk for disease, diagnose disease and its severity, guide intervention strategies, and monitor patient responses to therapy. ECG markers may predict whether a drug or other intervention is safe and effective in a shorter time and at lower cost than clinical outcomes studies.
If you are interested in receiving a copy of the form, please send your request to betty.mykins@heart.rochester.edu .

From left to right: Kasper Lundhus, Jens Stampe Soerensen, Lars Johannesen, and Ulrik Silvanus Lerkevang Grove. The students received their certificate from the Center after a semester in Rochester, NY.

THEW Educational Program: Four international students completed the THEW Training Program in Rochester (NY)

The Center for Quantitative Electrocardiography and Cardiac Safety and its Telemetric and Holter ECG Warehouse (THEW) initiative propose a set of training classes for U.S. and international students (graduate, PhD and post-doctoral levels). Primarily related to research activities in the field of digital quantitative electrocardiography, the program provides an unique opportunity to learn about ECG digital signal processing, electrocardiography, and clinical research . The Winter 2009 Session was just completed. Four students from Alborg University (Denmark), Jens Stampe Soerensen, Lars Johannesen, Kasper Lundhus and Ulrik Silvanus Lerkevang Grove received their certificate at the end of the year 2009.

" We are used to working in groups where the focus of the supervisor is the entire group. We liked, how the program worked where the focus not only was on the progress of the entire group but also on the individual student." commented Ulrik Grove, Lars Johannesen added "Weekly presentation was a great exercise in improving our presentation skills, and including ''outside experts'' to listen to our presentations." The students have worked on four research topics utilizing the ECG data from the THEW. They included ECG wave delineation, ECG wavelet filtering, the development of an improved RR-bin method, and an algorithm for the classification of T-wave morphology. Their works are being submitted for publication. Please visit the following page to learn more about the training program: www.thew-project.org/Education.htm.

If you are interested in taking training in the Center or would liek to learn more about the program please contact: betty.mykins@heart.rochester.edu.

Michal Benita-Weiss was born in Israel, and moved to the United States in 1998. She graduated from the Hebrew University of Jerusalem with a BA degree in Chemistry in 1992.  Following graduation she worked in the pharmaceutical industry for 6 Years. She then completed a masters degree in Public Health at the University of Rochester NY. Her first position in the US was in Pediatric Oncology where she coordinated clinical trials focusing on brain tumors, afterward she worked for a year in family medicine, coordinating family planning research, and during the past five years she has work as a senior research coordinator managing multi-center studies in Cardiology. Her responsabilities in the THEW organization are to manage THEW membership accounts, triage the submission of research proposals, manage the various requests for THEW members and to organize the THEW events.

Michal Benita-Weiss. THEW Project Coordinator