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- W4377012893 abstract "Sudden cardiac death (SCD), caused by ventricular arrhythmias (VA), is a major cause of death. Rates of SCD and VA are known to be affected by race and gender. Minorities have worse outcomes and are less likely to receive primary prevention ICDs. Representation of minorities in VA trials is not well documented. To evaluate sex, racial and ethnic inclusion rates in VA trials. The NIH website ClinicalTrials.gov was queried for trials including the terms “ventricular tachycardia,” ventricular fibrillation, or sudden cardiac death. Only trials that were completed with results available were included. All trials were manually reviewed and results confirmed in manuscript, if available. Patient sex, race, and ethnicity data were recorded. Race and ethnicity categories were defined according to 2015 NIH statement. Trials were divided based on funding source (academic, industry or federal), start date, focus of trial (prevention/detection or treatment), and etiology of VA (ischemic, structural, genetic/idiopathic, not specified/all). To examine representation based on incidence of VT/VF in the population, participation to incidence ratio (PIR) was calculated by dividing the percentage of a group among trial participants by the percentage of that group among the disease population. Values of 0.8 to 1.2 reflect similar representation. Participation to total population ratio (PTPR) was also calculated by dividing the percentage of a group among trial participants by total US population of that group based on current census data. Thirty-seven trials were identified. Three were excluded for not pertaining to VA, for a total of 34 trials with start dates ranging from 7/2005 to 8/2020. All trials represented sex. Of the 12,532 participants, 23.5% were female. Twenty-one (61.8%) trials with 7,205 participants reported race: White (77.5%), Black or African American (14.6%), Asian (2.3%), AIAN (0.8%), NHPI (0.2%), >1 race (0.5), other/unknown (3.3%). Twelve (35.3%) trials, which included 3,077 participants, reported ethnicity: Hispanic (3.1%), non-Hispanic (96.6%), other/not reported (0.3%). PIR and PTPR, stratified by funding source, start date, focus of trial and etiology of VA are shown in figure. Only two-thirds of the trials reported race, and minorities remain underrepresented. White males continue to be overrepresented in clinical trials including those funded by federal government. Findings from these trials may not be generalizable." @default.
- W4377012893 created "2023-05-19" @default.
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- W4377012893 date "2023-05-01" @default.
- W4377012893 modified "2023-09-24" @default.
- W4377012893 title "PO-05-160 SYSTEMATIC REVIEW AND META-ANALYSIS: INCLUSION OF GENDER, RACIAL AND ETHNIC MINORITIES IN VENTRICULAR ARRHYTHMIA AND SUDDEN CARDIAC DEATH TRIALS" @default.
- W4377012893 doi "https://doi.org/10.1016/j.hrthm.2023.03.1374" @default.
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