CAROTID REVASCULARIZATION ENDARTERECTOMY VS. STENTING TRIAL: LONG TERM FOLLOW-UP
J Virginia
Univ Of Med/dent Of Nj-nj Medical Schoolcity: Newark country: United States (us)
Grant 2R01NS038384-12 from National Institute Of Neurological Disorders And Stroke
Abstract: This is a competitive renewal for the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) that is designed to establish the relative efficacy of carotid endarterectomy (CEA) versus carotid artery stenting (CAS). During the initial funding period we have successfully completed enrollment of our pre-specified cohort of 2522 participants. Peri-procedural and mid-term outcomes, over a projected mean follow-up of 2.8 years, will be reported in February of 2010 or earlier. The primary results from CREST, publication of the primary results from ICSS, and the results of other revascularization trials including SAPPHIRE, EVA-3S, and SPACE will provide solid "Level 1A" evidence to guide carotid treatment over a 2 to 4 year time horizon. This is in contrast to patients living decades after CEA and CAS have been performed. The discordance between the time horizons of studies and the duration that patients may benefit creates a knowledge gap where there is a true dearth of evidence. In this competitive renewal we seek funding to continue to monitor these participants for an additional 5 years, with the potential for follow-up of up to 10 years. Our Primary Aim is to extend follow-up of the CREST cohort beyond 4 years and to assess the relative efficacy of CEA versus CAS over the 6 to 10 year post-procedural period in the prevention of ipsilateral stroke. Secondary aims will 1) assess if there are effect modifiers of the long-term durability of the two procedures, such as age, sex, pre-operative degree of stenosis and symptomatic status, 2) assess if there is a temporal change or pattern in the relative efficacy of the two procedures, 3) assess differences between groups in the rates of restenosis or revascularization, 4) link Medicare-eligible CREST participants with inpatient and outpatient CMS data files to assess patient outcomes and utilization of healthcare services, 5) collect DNA on available randomized subjects for future studies of genetic determinants of response to revascularization. We plan to extend follow-up of the existing 2522 enrolled with annual clinic visits interspersed with midpoint telephone contacts, from an average 2.8 years at the time of primary outcome reporting to an average 7.5 years, with a maximum follow-up of 10 years. With extended follow-up, statistical analysis of the primary aim will assess post-procedural treatment differences from Day 31 for up to 10 years of follow-up and is designed to provide 90% power to detect a hazard ratio of 1.67. With the focus of long-term follow-up on clinical outcomes, simplification of the follow-up protocol will result in reduced patient/clinic burden, reduced cost, and improved data quality. It is anticipated that CREST long-term results will have practice-changing implications regarding the standard of care for managing symptomatic and asymptomatic carotid arterial stenosis. CREST will provide data regarding the long-term durability of CEA versus CAS for the medical community, CMS and other healthcare agencies to empower decision-making for the optimum management of carotid disease with a corresponding reduction in the number and cost of strokes annually. Linkage to CMS in- and out-patient data files will provide a model for resource utilization and cost of care for the elderly and future studies
Keywords: Affect; Age; Budgets; care episode; Caring; Carotid Arteries; Carotid Endarterectomy; Clinic; Clinic Visits; Clinical; Clinical Research; clinical research site; Clinical Trials; cohort; Communities; cost; Data; Data Files; Data Quality; Decision Making; design; Disease; DNA; Elderly; empowered; Endarterectomy; Enrollment; Event; experience; follow-up; Funding; Future; Genetic Determinism; hazard; health care service utilization; Healthcare; hemodynamics; improved; Individual; Inpatients; interest; Ipsilateral; Knowledge; Length; Life; Link; Medical; Medicare; Modeling; Monitor; North America; Outcome; Outpatients; Participant; Patients; Pattern; Phase III Clinical Trials; Phenotype; Positioning Attribute; Prevention; primary outcome; Procedures; Protocols documentation; public health medicine (field); Publications; Randomized; Recurrence; Relative (related person); Reporting; Resources; response; restenosis; Risk; Savings; sex; Solid; Specific qualifier value; standard of care; Stenosis; Stents; stroke; Telephone; Testing; Time
Relevance: CREST will provide data regarding the long-term durability of CEA versus CAS for the medical community, CMS and other healthcare agencies to empower decision-making for the optimum management of carotid disease with a corresponding reduction in the number and cost of strokes annually. Linkage to CMS in- and out-patient data files will provide a model for resource utilization and cost of care for the elderly and future studies
Project start date: 1999-01-15
Project end date: 2016-12-31
Budget start date: 15-JAN-2012
Budget end date: 31-DEC-2012
2R01NS038384-12 (2012): $3674594
Sponsored Links Excellgen http://Excellgen.com
Grants awarded to J Virginia
CHILDHOOD SES FACTORS: IMPACT ON AGE-RELATED COGNITIVE AND VASCULAR HEALTH
J Virginia, Assistant Professor
University Of Alabama At Birminghamcity: Birmingham country: United States (us)
Grant 1R01AG039588-01A1 from National Institute On Aging
Abstract: U.S. blacks have a life expectancy that is significantly shorter than whites, with a larger difference between men than women. Cardiovascular diseases (CVD) are the single largest contributor to this disparity. Geographic disparities in health are similar to racial disparities in magnitude and effect. There is growing recognition that there are shared risk factors for CVD and cognitive impairment. Much of the research attempting to explain these racial and geographic disparities in health has focused on the participant´s socioeconomic status (SES) or place of residence at the time of diagnosis or death. Increasing evidence, however, points to an important role of exposures during earlier lifecourse periods. The role of lifecourse exposures is difficult to study, however, because migration patterns obscure the links between geographic exposures and long- term health outcomes. The general aim of this study is to identify childhood and family SES factors (CH-SES) that shape disparities in vascular and cognitive health. Designed to determine the causes of racial and geographic differences in stroke incidence, mortality and cognitive decline, the REGARDS (REasons for Geographic And Racial Differences in Stroke) study is a national population-based cohort study. REGARDS recruited 30,239 participants aged 45 or older, from 2003-2007, 45% men, 42% blacks. Data were collected using a combination of telephone interview, in-home physical exam, and self-administered questionnaire. Participants are currently being followed for CVD events and cognitive assessments. Our approach builds on the exceptional resources in REGARDS, in particular, the detailed residential history data. This study proposes to obtain data on CH-SES factors from three sources 1) new data collected from the cohort via a mail-questionnaire; 2) linking existing REGARDS data on childhood residence to public Census data on family and community level SES conditions; and 3) linking existing REGARDS data on childhood residence to historic public school records on school quality at the county/school district level. These data on CH-SES will be linked to the detailed data on demographic and clinical characteristics of the cohort and examined as predictors of CVD and cognitive decline over follow-up. This research focuses on the contribution of social factors to geographic and racial disparities in cardiovascular disease and cognitive impairment. Differences in social conditions across the lifecourse confound black-white and regional comparisons where childhood exposures probably influence associations between adult exposures and health outcomes. Understanding social contributors and ages where they are most influential are important to efforts to reduce health disparities across all racial and geographic groups
Keywords: Accounting; Address; Adult; African American; Age; age related; aged; American; Appalachian Region; Area; Blood Vessels; Cardiovascular Diseases; cardiovascular disorder risk; Censuses; Cessation of life; Characteristics; Childhood; Clinical; Cognitive; cohort; Cohort Studies; Communities; Coronary; County; Data; Data Set; Data Sources; Deep South; design; Diabetes Mellitus; Diagnosis; Disadvantaged; Educational aspects; Educational Background; Enrollment; Environment; Evaluation; Event; Exposure to; Family; Family Characteristics; follow-up; Future; geographic difference; Goals; Health; health disparity; Home environment; Hypertension; Impaired cognition; improved; Incidence; indexing; Individual; infancy; Influentials; Intervention; Lead; Life; Life Expectancy; Link; Longitudinal Studies; Mails; Measures; Mediator of activation protein; men; Methods; migration; Mississippi; Mortality Decline; Mortality Vital Statistics; Ohio; Outcome; Participant; Pathway interactions; Pattern; Population; population based; population health; Questionnaires; racial difference; Reasons for Geographic And Racial Differences in Stroke; Recording of previous events; Records; Recruitment Activity; repository; Research; residence; Resources; Risk; Risk Factors; Rivers; Role; Schools; Self-Administered; Shapes; social; Social Conditions; Socioeconomic Status; socioeconomics; Source; stroke; Telephone Interviews; Time; Woman
Relevance: This research focuses on the contribution of social factors to geographic and racial disparities in cardiovascular disease and cognitive impairment. Differences in social conditions across the lifecourse confound black-white and regional comparisons where childhood exposures probably influence associations between adult exposures and health outcomes. Understanding social contributors and ages where they are most influential are important to efforts to reduce health disparities across all racial and geographic groups
Project start date: 2011-09-30
Project end date: 2016-08-31
Budget start date: 30-SEP-2011
Budget end date: 31-AUG-2012
PFA/PA: PA-10-067
1R01AG039588-01A1 (2011): $633916