Outcomes Registry In Heart Attack Patients To Generate Numerous Studies; Data Quality Ensured Through Velos Clinical Research Management System

Main Category: Heart Disease
Also Included In: Medical Practice Management;  Clinical Trials / Drug Trials
Article Date: 09 Oct 2009 - 3:00 PDT

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An important observational registry evaluating processes of care and one-year outcomes of over 4300 heart attack patients is now being completed. Researchers at the Saint Luke's Mid America Heart Institute in Kansas City, MO have led this observational research study in collaboration with 23 other hospitals throughout the U.S. A vast knowledge store, produced from the significant size and diversity of this cohort, is expected to generate numerous publishable studies in the years ahead. The complex information repository was populated with help from the Velos eResearch Clinical Research Management System to ensure the quality and validity of data that will be available for all studies.

"We have a rich treasure trove of valid data, collected through a huge, observational snapshot of the processes of care for treating acute myocardial infarction patients and their subsequent outcomes," said principal investigator, John A. Spertus, M.D., medical director of cardiovascular education and outcomes research at Saint Luke's Mid America Heart Institute in Kansas City, Missouri; professor of cardiology at the University of Missouri, Kansas City; and adjunct professor of medicine at Washington University School of Medicine. "This venture fits within our overall vision of improving the quality of care in heart attack patients - and it represents a significant evolutionary step in our increasingly complex studies. Velos eResearch provided the foundation for our data collection from this very large, diverse cohort."

Referred to as TRIUMPH (Translational Research Investigating Underlying Disparities in Myocardial Infarction Patients' Health Status), this registry is unique in the breadth and depth of the sociodemographic and clinical characterization of heart attack patients and their clinical and health status outcomes over time. Health status is often overlooked, yet acknowledged as the best approach for measuring outcomes that are most relevant to patients. The NIH (National Institutes of Health) funding of TRIUMPH has made possible the rigorous, complex and labor-intensive effort to collect these data, which included hospital chart abstraction, lab data, extensive interviews, in-home assessments on many patients, and adjudicated repeat hospitalizations. An estimated 2500 pieces of information have been collected on each patient as to their post-hospitalization functional status. Data from all interviews forms are captured by Velos eResearch. One-month, six-month and 12-month interviews, coordinated through a centralized call center at Yale University, were conducted. Data from one-year follow-up will be complete by first quarter 2010.

"We were able to leverage numerous features of the Velos system to create numerous data logic checks to ensure the quality of data entered," continued Spertus. "For example, if a patient is male, the system will not allow a 'post-menopausal' field to be checked. Similarly, insulin could not be registered as a medication without a diagnosis of diabetes. This has helped us a great deal to know that we have valid data upon which we can conduct our planned analyses."

A network of researchers will use the opportunity of having access to this large repository for a variety of studies. Some might want to look at patients' physical functioning after heart attack and some might be interested in depression. Some will study the types of treatments received and the efficacy of medications prescribed upon discharge. The linking of our data to genetic samples also enables numerous genomic and pharmacogenomic analyses to be conducted. A team of statisticians will work full time over the next several years to support this undertaking. The analytic phase of this study kicks off this October with a gathering of research scientists to explore the many studies possible with this registry. "I would guess, over the next five years, we'll probably generate more than a hundred papers," continued Spertus.

"We are honored to be associated with medical research of this magnitude," said John McIlwain, Velos President and CEO. "Functional status is a key to learning best practices. To provide researchers the confidence they need, in order to know that they are working with good data in their research endeavors, is very gratifying."

About the Saint Luke's Mid America Heart Institute

The Saint Luke's Mid America Heart Institute established its research section in 1980. The Institute has served as a national model for development of successful research programs. More than one hundred studies are currently underway. The goal of clinical research is to increase the body of knowledge in the field of medicine. Translating scientific and engineering discoveries into effective new therapies for people in and around Kansas City is at the heart of what the Institute does. Saint Luke's participates in clinical research and the clinical application of medical research through clinical studies designed according to FDA regulations. Additionally, the Institute is at the forefront of translational research, bringing the study from the lab to the bedside. The Saint Luke's Health System is a faith-based, not-for-profit aligned health system committed to the highest levels of excellence in providing health care and health related services in a caring environment. The nineteen-hospital health system is dedicated to enhancing the physical, mental and spiritual health of the communities served.

About Velos

Velos is the trusted clinical trial management resource for investigators, sponsors and academic leaders throughout the U.S. The company serves 21 Top 25 U.S. medical centers. Velos eResearch is deployed for clinical research in all parts of the healthcare enterprise and supports a broad diversity of clinical departments and functional needs. The system fundamentally improves the way data is collected, organized and shared. A pure Internet technology platform, Velos eResearch harnesses advanced powers of the Internet to enable research sites, sponsors, and patients to participate in a secure, integrated system platform. System users are freed of redundant data entry and related time delays associated with most clinical research today. With emphasis on workflow, Velos integrates the clinical, administrative and financial information needs of research management. Velos eTools, a companion product to Velos eResearch, empowers customers by giving them ownership and access to functions such as system configuration, data migrations, custom reporting and third party data submissions.

This press release may contain forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements.

Source: Velos