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临床试验/NCT04525937
NCT04525937Unknown不适用

Racial and Economic Disparities and Unmet Needs in Patients With Severe Aortic Valvular Disease

Minneapolis Heart Institute Foundation1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年6月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
MACE (Major Adverse Cardiac Event)

研究概览

简要总结

Common barriers to receiving appropriate guideline-driven care for patients with severe aortic stenosis include referral biases by primary care providers (lack of provider education), patient comorbidities (degree of fragility), as well as psychosocial issues and cultural barriers. Additionally, race, ethnicity, socioeconomic status (SES) and education level are shown to be persistent barriers to accessing healthcare services and healthcare systems, creating a significant practice gap between various patient populations. The most recent transcatheter valve therapies (TVT) registry data show that >94% of TAVR recipients are Caucasian, followed by less than 4% of African-Americans and Hispanics, respectively. There is a critical need to understand the barriers to treatment and care among severe aortic valve disease patients of disparate groups. This study is a multi-center, retrospective and prospective cohort study of patients diagnosed with severe aortic stenosis. Additionally, we will be surveying referring primary care providers, cardiologists and cardiovascular surgeons to assess their current referral practices for patients with severe aortic stenosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Disparity/Diversity background (either race/ethnicity, low SES (adults with incomes at or below the federal poverty level (family income to poverty ratio, ≤1), language (non-English speaker) or education (≤9 years of education))
  • Patient scheduled for transcatheter aortic valve replacement using the Edwards Sapien valve, OR recently implanted with Edwards Sapien valve (up to 1 year post-TAVR)
  • Echocardiographic diagnosis of severe, symptomatic AS and intermediate to high surgical risk per Society of Thoracic Surgeons (STS) mortality risk-score

排除标准

  • Age < 18
  • Patients who do not allow their records to be used for research

结局指标

主要结局

MACE (Major Adverse Cardiac Event)

时间窗: 30 days and 1 year

Patient Mortality

时间窗: 30 days and 1 year

次要结局

  • Referring physician- related barriers/biases.(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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