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临床试验/NCT03860246
NCT03860246已完成不适用

Screening for Atrial Fibrillation in High-Risk Nursing Home Residents

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
245
试验地点
1
主要终点
atrial fibrillation

研究概览

简要总结

This study was designed to screen high risk patients in nursing homes for atrial fibrillation with intermittent electrocardiogram (ECG) recordings using a portable, smartphone-based, mobile ECG recording device (Kardia Mobile, AliveCor, Inc.). The investigators hypothesized that screening patients with 2 or more risk factors for atrial fibrillation would yield a higher incidence of atrial fibrillation compared to prior studies.

详细描述

This is a prospective study that enrolled 245 residents from 15 participating nursing homes with ≥2 risk factors for atrial fibrillation. All residents gave informed consent or had a legally appointed representative who could consent on their behalf. Exclusion criteria included residents with a prior diagnosis of atrial fibrillation, continuous rhythm monitoring over the past year, and pacemaker or implantable cardioverter defibrillator in situ.

Screening was performed using the smartphone-based, mobile ECG recording device. Thirty second rhythm recordings were obtained on each resident on four different occasions within a month. All tracings were reviewed by a cardiologist and, in the case of any uncertainty, the diagnosis of atrial fibrillation was confirmed by an electrophysiologist. When atrial fibrillation was detected in a resident (primary endpoint), no further rhythm recordings were performed and the resident's nursing facility was then notified of the diagnosis. Further evaluation and treatment were directed by the resident's primary care physician.

All data were stored on a secure encrypted server with password protection. The investigators used chi-square and t-test analyses to determine if there were significant differences in demographic variables or risk factors for atrial fibrillation between residents with and without atrial fibrillation. Logistic regression analysis determined if any combination of risk factors was predictive of a positive atrial fibrillation screen.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Nursing home residents with ≥2 of the following risk factors for atrial fibrillation:
  • age ≥75 years
  • female sex
  • obstructive sleep apnea
  • peripheral vascular disease
  • diabetes mellitus
  • obesity (body mass index [BMI] >30 kg/m2)
  • hypertension
  • congestive heart failure

排除标准

  • prior diagnosis of AF
  • continuous rhythm monitoring over the past year
  • pacemaker or implantable cardioverter defibrillator in situ

结局指标

主要结局

atrial fibrillation

时间窗: 30 days

number of participants with atrial fibrillation on any of four rhythm recordings

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Curtis

SUNY Distinguished Professor

State University of New York at Buffalo

研究点 (1)

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