THEW and Northwestern University collaborate to host Holter ECGs from the DEFINITE Trial in the THEW
Database: E-HOL-03-407-017
The purpose of the Defibrillator in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Trial was to determine if
the combination of
ICD therapy to optimal medical therapy reduces all-cause mortality in non-ischemic cardiomyopathy patients with low ejection fraction and
NSVT/PVC's compared to optimal medical therapy only. The enrolled patients in this trial had a diagnosis of nonischemic dilated
cardiomyopathy, a LVEF < 36%, and PVC's or unsustained ventricular tachycardia. The control group received standard medical therapy, while
the test-ICD group received standard medical therapy and a single-chamber ICD. At 2 years, the mortality rate was greater in the control
group (14.1%) than the test-ICD group (7.9%). There were significantly more sudden deaths from arrhythmia in the control group than there
were in the test-ICD group (p=0,006). The investigators concluded that the combination of ICD therapy with standard optimal medical therapy
reduced the risk of sudden death from arrhythmia in patients with severe non-ischemic dilated cardiomyopathy.
We are glad to announce that the Holter ECG recordings acquired in this trial are now hosted in the THEW and are available for
research. Two hundred and thirty nine patients were enrolled in this study and got an Holter ECG recording acquired either at enrollment of
later during the trial, the patients were followed for 29 months in average. The enrollment criteria included LVEF<36%, the presence of
ambient arrhythmias, a history of symptomatic heart failure, and the presence of non-ischemic dilated cardiomyopathy. Ambient arrhythmias were
defined by an episode of non-sustained ventricular tachycardia on Holter (3 to 15 beats at heart rate superior to 120 beats per minutes)
(different from the ECGs hosted in this database). The acquisition of the Holter recordings was initiated after the start of the trial. ECGs
were acquired at baseline or at the next scheduled follow-up visit for patients who were already enrolled in the study.
Importantly, the THEW designed a specific type of research agreement with Northwestern University (Chicago, IL) in order to enable the
distribution of the DEFINITE data to the Scientific community. This agreement includes the involvement of a special committee to review the
research proposal proposed by THEW members. This committee consists of Prof. Alan Kadish, his collaborators and members of the THEW steering
committee. This ad-hoc group will be appointed according to the topics of the research proposal submitted by the THEW members.
To learn more about this new database please click here. here.
| Accessing the data from the THEW |
To access the data from the warehouse, you can request for a demo. version of the THEW Client Application which let you connect to a database containing Holter ECGs from the repository. To access to all data from the THEW , register and become member of our initiative here. The THEW is a not-for-profit organization. |
| About Us |
The Steering Committee(SC) of the Telemetric and Holter ECG Warehouse (THEW) has been formed during the second quarter 2008, the nine individuals in the SC are from the National Health Institute, the Center for Drug Evaluation and Research, the Commissioner Office of the Food and Drug Administration (FDA) and the University of Rochester Medical Center. Read more about our team. |
Keep informed about our activities by joining our LinkedIn group. More than 379 professionals have already registered.
[09/23/2010]: AstraZeneca joins the THEW to further cardiac safety inThe Medical News: here.
[12/16/2009]: The Director of the THEW interviewed by Technology Review published by the MIT: here.
[11/11/2009]: New Research Center to Focus on Cardiac Safety and Innovation in Pharmaceutical Industry Today: here.
[6/11/2009]: University of of Rochester and FDA Partner for ECG Database, Drug Discovery & Development Magazine. More info here
[5/6/2009] FDA website Existing Partnerships FDA’s Public-Private Partnership Program: THEW
[03/28/2009] Public and Private part- nership to help determine Clinical Biomarker Utility in Applied Clinical Trials online.com.>here
[01/10/2012] Department of Physiological Nursing, University of California, San Francisco, CA, USA
The Mission of the Department of Physiological Nursing prevention of UCSF is to study the prevention, measurement, and treatment of physiological and biobehavioral responses to health, illness/disease and aging. Psycho-physiological interrelationships and interventions also are studied. Research spans all phases of the health/illness trajectory including people who are healthy, critically ill, living with a chronic illness, and those at the end of life.
[01/03/2012] University of Bologna (HST-ICIR) , Bologna, Italy
The University of Bologna was probably the first University in the western world. Its history is one of great thinkers in science and the humanities, making it an indispensable point of reference in the panorama of European culture. Bologna has thus been called upon to forge relationships with institutions in the most advanced countries to modernise and expand its activity. Among the many challenges which it has met with success, Bologna committed itself to the European dimension which has now led to adoption of the new university system.
[11/08/2011] Long Beach Memorial Medical Center, Long Beach, CA, USA
Long Beach Memorial Medical Center has been recognized as a major regional provider of medical and surgical services. Long Beach Memorial consistently achieves national accolades for its quality care, including being named as one of the U.S. top 125 hospitals by Consumers CHECKBOOK; named Top 100 Hospitals Cardiovascular by Thomson Reuters; and named one of Americas Best Hospitals for Orthopedics by U.S. News and World Report magazine.
[11/08/2011] University of Ljubjana, Ljubjana Slovenia
The university of Ljubjana was founded in 1919 on the basis of centuries of educational tradition, remaining the only Slovenian university for half a century.The very beginnings of medical education in Slovenia began in 1653 with the establishment ACEDEMIAE Operosorum in Ljubljana, where the medical component led by M. Gerbec (Gerbecius) by the first full description of symptoms and signs of atrio-ventricular block, disturbance, which was only possible to objectively define the development of electrocardiography several centuries later.
[11/02/2011] University of Adelaide, Adelaide, Australia
School of Electrical and Electronic Engineering: The School of Electrical and Electronic Engineering of University of Adelaide was formally founded in 1946, however courses were run in conjunction with other schools for a number of years before that. Over the years the curriculum has retained its essential nature as a broad curriculum founded on a strong basis of science, maths and technology principles.
[10/24/2011] Philips Heathcare-AARC, Andover, MA. USA
The Advanced Algorithm Research Center(AARC)is a Philips-sponsored professional organization established in late 2000, the AARC is devoted to advanced research and development in all areas of ECG analysis, including diagnostic electrocardiography, arrhythmia analysis, stress testing, patient monitoring and resuscitation.
[07/18/2011] University of Utah, Salt Lake City, UT. USA
The Department of Internal Medicine is the single largest department on the University of Utah campus, and has 14 subspecialty divisions. Its education program is nationally recognized for excellence. And, despite the small size relative to other institutions, this group is one of the top research departments in the United States, with numerous multi-year awards.
[06/28/2011] Medial Research, Ramot-Hashavim Israel
Medial Research is a private research institute established with the purpose of making research as well as application breakthroughs in personalized medicine. Medial aspires that the results of its findings will allow patients to benefit from personalized medical treatment adapted to each patient's specific clinical, physiological and demographical parameters.
[06/27/2011] Universidad Favaloro, CABA Argentina
The Favaloro University (Spanish: Universidad Favaloro) is an Buenos Aires Argentine, private university in the city of Buenos Aires. It was founded by surgeon Rene Favaloro in 1998. Research at the Favaloro University is distributed between the Faculty of Medical Sciences, the Faculty of Engineering and Exact and Natural Sciences and the Institute of Cardiology and Cardiovascular Surgery.
[05/23/2011] FDA-NCTR, Jefferson, AR. USA
The National Center for Toxicological Research (NCTR), FDA internationally recognized research center, plays a critical role in the FDA mission. NCTR-in partnership with researchers from elsewhere in FDA, other government agencies, academia, and industry-provides innovative technology, methods development, vital scientific training, and technical expertise. The unique scientific expertise of NCTR is critical in supporting FDA product centers and their regulatory roles.
[02/28/2011] Johns Hopkins University School of Medicine, Baltimore, MD. USA
World-renowned for its medical research and advances, Johns Hopkins Medicine includes a variety of Core Facilities. Designed to encourage and enable cutting-edge research in the areas of basic science, genetics, medicine and others.
[05/27/2008]: "THEW Beyond QT working Group" releases an ECG marker submission form designed in collaboration with the FDA.
NHLBI Support[12/13/2009]:The University of Rochester and the NHLBI enabled the creation of a "Center for Quantitative Electrocardiography and Cardiac Safety" (CES). Read more...
Agreement[05/27/2008] FDA: Dr. J. Woodcock (Director, CDER-FDA) and Dr. Norman Stockbridge (Director for the Division of Cardiovascular and Renal Products, CDER-FDA) signed a Letter of Agreement officially starting the partnership between the FDA and University of Rochester for the THEW initiative. More...