Risk Stratification of End Stage Renal Disease patients: continuous 48-hour 12-lead high-resolution ECG during and after
hemodialysis session
Database:E-HOL-12-0051-016
End Stage Renal Disease (ESRD) is a costly and disabling condition that disproportionately affects
racial/ethnic
minority populations and is associated with a high mortality rate (230 per 1000 patients/year). The number of ESRD
patients has increased at an average yearly rate of 3-4% between 1996 and 2005 in the United States. In 2000, there were
~281,000 US dialysis patients, and the projection forecasted ~520,000 dialysis patients in 2010. Today, there are
approximately half a million people in the US with ESRD on hemodialysis and the annual mortality rate among these
patients is close to 25%. Cardiac disease is implicated in as many as 44% of these deaths. Amongst those, cardiac
arrhythmias represent 61% of all cardiac deaths.
Several prospective multicenter trials (MADIT I/II, AVID, CASH and CIDS) have demonstrated the benefit of ICD
therapy
for the reduction of sudden cardiac death (SCD) in high risk patients. A meta-analysis of three trials suggested better
survival with ICDs with a 28% reduction of risk (p<0.0006). Unfortunately, dialysis patients were, in general, excluded
from the large randomized trials. Retrospective studies suggested important benefits of ICDs in dialysis patients. Based
on a group of 5,582 patients with acute myocardial infarction in which 460 dialysis patients (~8%) were implanted with
ICDs, Herzog et al. reported a 42% reduction in cardiac risk. The study also emphasized the underutilization of the ICDs
in this population. This observation was consistent with the results from Voigt et al. in 2004 describing ICD
implantation in a group of survivors of cardiac arrest between 1996 and 2001: 31% were implanted whereas only 18% of
dialysis patients surviving cardiac arrest received an ICD. Because the dialysis patients are at high risk for SCD, it
is not surprising that most studies emphasize that these patients have the most to gain from receiving life-saving ICD
therapies. At present, there are no specific clinical guidelines for the prescription of ICDs in ESRD patients and
clinicians need risk- stratification methods to alter the abysmal outcome these patients are facing.
The Telemetric and Holter ECG Warehouse has added a new set of continuous 48-hour high-definition (1000Hz) ECG
recordings acquired in ESRD patients in order to provide the opportunity to scientists to investigate whether there is
information in the surface ECGs that could help better identify the high-risk patients with ESRD. Thirteen months follow
up on a set of 51 patients recorded during hemodialysis and for a period of two days are available. Eleven patients died
during the study follow up.
To learn more about this new dataset click here.
| Accessing the data from the THEW |
You can download a version of the THEW ECG viewer and download examples of Holter ECGs from our repository. Or you can become member to gain access to the data from our repository here. |
| About Us |
The Steering Committee(SC) of the Telemetric and Holter ECG Warehouse (THEW) has been formed during the second quarter 2008, the eight 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. |
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[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
[01/26/2012] FDA-CDRH: Center for Devices and Radiological Health, Silver Spring, MD USA
FDA Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
[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...