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Linking Cardiovascular Health Study Data to CMS Data
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Research Initiative
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CMS
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NHLBI
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The Cardiovascular Health Study (CHS) is a population-based longitudinal study of risk factors for the development of cardiovascular disease (CVD) and stroke in 5,888 men and women aged 65 and older. Annual examinations through 1999 included measures of possible and proven cardiovascular disease risk factors and measures of subclinical disease. The cohort has been followed for coronary heart disease, stroke, congestive heart failure, peripheral arterial disease, and mortality. The study is currently supported by contract funding for infrastructural functions and by investigator-initiated grants and other outside sources for research projects. CMS data are being used to enhance CHS CVD outcomes research by enabling researchers to study determinants related to medical care access, quality, cost, and outcomes. Conference calls are conducted among staff of the study, the CMS, and the NHLBI to discuss the data availability, confidentiality, quality, distribution, and to identify research opportunities.
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Linking Atherosclerosis Risk in Communities (ARIC) Data to CMS Data
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Research Initiative
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CMS
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NHLBI
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The Atherosclerosis Risk in Communities (ARIC) study, which began in 1985, seeks to 1) monitor trends in the incidence and mortality of coronary heart disease and heart failure through a surveillance program in four communities and 2) assess determinants in development and progression of subclinical and clinical cardiovascular disease (CVD) through a cohort follow-up study of 15,796 white and African American persons aged 45-64 at baseline. Since 2005, CMS data has been provided through an interagency agreement. The data is being used to validate and capture all the heart failure cases in persons aged 65 yrs and older in the ARIC cohorts and to validate and capture morbidity and mortality status of these individuals. In addition, CMS data are being used to enhance ARIC CVD outcomes research by enabling researchers to study determinants related to medical care access, quality, cost, and outcomes. Conference calls are conducted among staff of the study, the CMS, and the NHLBI to discuss the data availability, confidentiality, quality, distribution, and to identify research opportunities.
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Linking Framingham Heart Study Data to CMS Data
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Research Initiative
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CMS
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NHLBI
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The Framingham Heart study is a long-term, multigenerational study is designed to identify genetic and environmental factors influencing the development of cardiovascular and other diseases. Examination and testing of 5,209 residents of Framingham, Massachusetts, was initiated in 1948 and with approximately 700 members of the original cohort currently alive and under follow-up. An offspring cohort and a third generation cohort have been added. The project examines the incidence and prevalence of cardiovascular disease (CVD) and its risk factors, trends in CVD incidence and its risk factors over time, and family patterns of CVD and risk factors. Other objectives include the estimation of incidence rates of disease, a description of the natural history of CVD, including the sequence of clinical signs and systems that precede the clinically recognizable syndrome, and the consequences and course of clinically manifest disease. CMS data are being used to enhance Framingham CVD outcomes research by enabling researchers to study determinants related to medical care access, quality, cost, and outcomes. Conference calls are conducted among staff of the study, the CMS, and the NHLBI to discuss the data availability, confidentiality, quality, distribution, and to identify research opportunities.
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Linking Jackson Heart Study Data to CMS Data
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Research Initiative
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CMS
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NHLBI
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The Jackson Heart Study (JHS) is a multi-center investigation of predictors of cardiovascular disease (CVD) in 5301 African Americans living in counties surrounding the Jackson, MS, metropolitan area. The JHS was initiated in 1998 as a collaborative effort among three Jackson-area academic institutions. The JHS completed three back-to-back cohort examinations that have produced extensive longitudinal data on traditional and putative CVD risk factors, socioeconomic and sociocultural factors and biochemical analytes; measures of subclinical disease from echocardiography, cardiac magnetic resonance imaging (MRI), computed tomography (CT) scans of the heart, aorta and abdomen; and stored biological samples. In addition, the JHS has conducted annual cohort follow-up contacts for incident clinical events of interest, a variety of community education and outreach activities to promote healthy lifestyles to reduce disease risk burden, and level-appropriate training programs to promote and support public health research. Since 2011, CMS data has been provided through an interagency agreement to obtain services and expertise in acquisition and utilization of Medicare claims data for participants enrolled in the JHS. Combining the detailed clinical and epidemiological data of the JHS with the Medicare claims data allows (1) assessment of major events (hospitalizations, stroke, MI) for participants lost to follow-up, (2) validation of selected outcomes reported by participants, and (3) expansion of the JHS research agenda to address questions related to resource utilization among elderly JHS participants that could not be addressed using the JHS data or Medicare claims data alone. Conference calls are conducted among staff of the study, the CMS, and the NHLBI to discuss the data availability, confidentiality, quality, distribution, and to identify research opportunities.
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Linking Multi-Ethnic Study of Atherosclerosis Data to CMS Data
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Research Initiative
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CMS
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NHLBI
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The Multi-Ethnic Study of Atherosclerosis (MESA) investigates the prevalence, correlates, and progression of subclinical cardiovascular disease (CVD) and risk factors that predict progression to clinically overt CVD, and that predict progression of subclinical disease itself, in a population-based sample of 6,814 men and women aged 45-84 at baseline from four ethnic groups – white, African American, Hispanic, and Chinese. The cohort was recruited from six Field Centers in the US and characterized with respect to coronary calcification using computed tomography, ventricular mass and function using magnetic resonance imaging, and other measures at baseline. Several subclinical disease measures were repeated in 3 subsequent examinations, and fifth examination is underway (April 2010 – September 2011). Exam 5 includes a repeat cardiac MRI, including myocardial tagging to measure ventricular function. Approximately half of the cohort will undergo repeat cardiac CT and carotid ultrasound, supported by the EPA-funded ancillary study MESA Air Pollution. Participants will be followed for identification and characterization of incident CVD events and interventions received. CMS data are being used to enhance CHS CVD outcomes research by enabling researchers to study determinants related to medical care access, quality, cost, and outcomes. Conference calls are conducted among staff of the study, the CMS, and the NHLBI to discuss the data availability, confidentiality, quality, distribution, and to identify research opportunities.
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Linking Women''s Health Initiative Data to CMS Data
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Research Initiative
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CMS
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NHLBI
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The Women''s Health Initiative is a study of cardiovascular disease, cancer, and osteoporosis in postmenopausal women. Participant data from the NHLBI Women''s Health Initiative cohort is linked to Medicare data to allow researchers to identify clinical outcomes and to investigate the utilization and costs of medical services within the Medicare Program. Investigators are in negotiations with CMS to find the best way to share the data with qualified researchers.
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Live Attenuated Leishmania donovani p27 Gene Knockout Parasites Are Nonpathogenic and Elicit Long-Term Protective Immunity in BALB/c Mice
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Research Initiative
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FDA
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NHLBI
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Leishmaniasis causes significant morbidity and mortality worldwide, and no vaccines against this disease are available. Previously, we had shown that the amastigote-specific protein p27 (Ldp27) is a component of an active cytochrome c oxidase complex in Leishmania donovani and that upon deletion of its gene the parasite had reduced virulence in vivo. In this study, we have shown that Ldp27(-/-) parasites do not survive beyond 20 wk in BALB/c mice and hence are safe as an immunogen. Upon virulent challenge, mice 12 wk postimmunization showed significantly lower parasite burden in the liver and spleen. When mice were challenged 20 wk postimmunization, a significant reduction in parasite burden was still noted, suggesting long-term protection by Ldp27(-/-) immunization. Immunization with Ldp27(-/-) induced both pro- and anti-inflammatory cytokine responses and activated splenocytes for enhanced leishmanicidal activity in association with NO production. Protection in both short- and long-term immunized mice after challenge with the wild-type parasite correlated with the stimulation of multifunctional Th1-type CD4 and CD8 T cells. Adoptive transfer of T cells from long-term immunized mice conferred protection against virulent challenge in naive recipient mice, suggesting involvement of memory T cell response in protection against Leishmania infection. Immunization of mice with Ldp27(-/-)also demonstrated cross-protection against Leishmania major and Leishmania braziliensis infection. Our data show that genetically modified live attenuated Ldp27(-/-) parasites are safe, induce protective immunity even in the absence of parasites, and can provide protection against homologous and heterologous Leishmania species.
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Logical Observation Identifiers Names and Codes (LOINC)
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Resource Development
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AHRQ, CDC, CMS, HRSA, IHS, OS
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NLM
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This activity supports the maintenance, distribution, and continued development of Logical Observation Identifiers Names and Codes (LOINC®), a set of universal codes and names to identify laboratory and other clinical observations which facilitates the exchange and pooling of clinical results for clinical care, outcomes management, and research. The Regenstrief Institute, Inc, an internationally renowned healthcare and informatics research organization, maintains the LOINC database and supporting documentation, and the RELMA mapping program.
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Long-term Oxygen Treatment Trial
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Research Initiative
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CMS
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NHLBI
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The Long-term Oxygen Treatment Trial is a randomized controlled clinical trial to assess the efficacy of around-the-clock, supplemental oxygen therapy in subjects with chronic obstructive pulmonary disease and moderately severe hypoxemia. NHLBI will administer and oversee the study, and Medicare will cover the costs of items and medical services that are generally available through that program to beneficiaries enrolled in the trial.
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Longitudinal Study of Implantable Cardioverter-Defibrillators
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Research Initiative
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AHRQ
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NHLBI
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After randomized controlled trials demonstrated that implantable cardioverter-defibrillators (ICDs) reduce the risk of death in patients with left ventricular systolic dysfunction. The use of implantable cardioverter-defibrillators (ICDs) for primary prevention increased after randomized controlled trials demonstrated that they reduce the risk of death in patients with left ventricular systolic dysfunction. However, the extent to which the clinical characteristics and long-term outcomes of unselected, community-based patients with left ventricular systolic dysfunction undergoing primary prevention ICD implantation in a real-world setting compare with those of participants enrolled in the randomized, controlled trials is not well characterized. To address the issue, this study is being conducted in the Cardiovascular Research Network, in collaboration with AHRQ.
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