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临床试验/NCT06275503
NCT06275503招募中不适用

STROKESTOP III - Optimized Method for Atrial Fibrillation Screening

Danderyd Hospital3 个研究点 分布在 1 个国家目标入组 2,200 人开始时间: 2024年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,200
试验地点
3
主要终点
Participation in screening

研究概览

简要总结

Atrial fibrillation is the most common sustained cardiac arrhythmia affecting more than 3% of the adult population. The symptoms of atrial fibrillation can range from asymptomatic to debilitating. It can be permanent in its nature, but also paroxysmal with only short bursts of atrial fibrillation randomly occurring and can therefore remain unnoticed. Atrial fibrillation increases the risk of stroke five fold if left untreated.

Screening for atrial fibrillation in elderly populations above age 65 years can result in detection of new atrial fibrillation cases ranging from 0,5% new AF with a single time-point ECG, up to 30% AF if an implantable loop recorder is inserted for 3 years.

Currently opportunistic screening using pulse palpation, or a single time-point ECG is recommended by the European Society of Cardiology guidelines. Systematic screening in individuals aged 75 or above, or at a high stroke risk should be considered.

Overall, participation in systematic atrial fibrillation screening trials has been shown to be relatively low with almost 50% non-participants. Participants are generally healthier, with higher socioeconomic status, hence the ones who would potentially benefit the most remain absent.

Opportunistic screening has shown promising results with higher participation rates and the possibility of better outreach. There is a lack of data from randomized trials on the difference in participation rates in systematic and opportunistic screening approaches when screening with prolonged ECG monitoring.

详细描述

Plans and methods; Primary care facilities in the region of Värmland with at least 200 75-76 year-old listed will be randomized to either:

  1. Systematic screening. All 75/76 year old belonging to a primary care facility randomized to systematic screening will receive a letter with an invitation to screening through the Clinical Physiology department at Karlstad Central Hospital.
  2. Opportunistic screening. All 75/76 year old attending their primary care facility for any health related reason will be invited to screening at the primary care facility.

A complete list of all listed individuals will be drawn from each primary care facility list of patients for both screening arms at the beginning of the study.

Inclusion criteria: All individuals aged 75/76 residing in the region of Värmland, listed at a primary care facility with > 200 individuals aged 75/76 Exclusion criteria: Individuals with ongoing oral anti coagulation treatment (OAC), contraindication for OAC treatment and/or known and treated atrial fibrillation will be excluded from participation. Individuals not being able to consent will be excluded from participation.

All participants will be asked to fill out a health declaration. A hand-held single-lead ECG (Zenicor One) will be sent to the participant via mail. The device will be used to measure ECGs on a regular basis three times a day, and during symptoms. ECGs are transferred for interpretation through the mobile network. All ECGs will be manually interpreted by specifically trained physiologists.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
75 Years 至 76 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals aged 75/76 in 2024 (born 1948, 1949)
  • Must reside in the region of Värmland
  • Must be listed at a primary care facility

排除标准

  • Treatment with oral anti coagulation treatment (OAC)
  • Contraindications for OAC treatment
  • Prior atrial fibrillation
  • Unable to provide consent

结局指标

主要结局

Participation in screening

时间窗: 12 months

Proportion of invitees participating in screening in each screening arm. The primary hypothesis is that opportunistic screening will increase participation by 25 % compared to systematic screening

次要结局

  • AF detection in opportunistic compared to systematic screening(12 months)
  • OAC treatment after AF detection(12 months)
  • Compliance to OAC treatment 1 year after initiation(12 months)
  • Reminder strategy effect on participation(12 months)
  • Comparison of automatic ECG analysis (using AI) for detection of AF in a (by AI algorithm classified) high- compared to a low-risk group(12 months)
  • Composite endpoint of stroke, death and severe bleeding(5 years)
  • Health economy(12 months)
  • Application of the FIND-AF algorithm(12 months)

研究者

发起方
Danderyd Hospital
申办方类型
Other
责任方
Sponsor

研究点 (3)

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