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Clinical Trials/NCT06675383
NCT06675383RecruitingNot Applicable

SCREENING AFTER STROKE - ATRIAL FIBRILLATION - the SIGNIFICANCE of TIMING and CHOICE of DEVICE

Vestre Viken Hospital Trust1 site in 1 country410 target enrollmentStarted: November 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
410
Locations
1
Primary Endpoint
Impact of timing: Atrial fibrillation detection rate

Study Overview

Brief Summary

As much as 20-30% of all strokes are attributed to atrial fibrillation (AF), making the detection of AF highly important, as AF-related strokes are largely preventable with optimal treatment. Therefore, most guidelines recommend screening patients for AF after a stroke, although the optimal timing and choice of monitoring device for screening remain undefined. Our aim is to investigate whether AF screening as early as possible after stroke symptom onset provides a higher detection rate compared to screening after discharge. Additionally, we aim to determine if a 3-lead ECG device provides a higher detection rate compared to a 1-lead patch recorder.

Detailed Description

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias, affecting over 2% of all adults in the general population, with prevalence increasing with age and cardiovascular risk factors. AF is responsible for at least 20% of all stroke cases, and stroke may often be the first manifestation of AF. Compared to strokes of other etiologies, AF-related strokes are associated with larger infarctions, worse outcomes, and higher mortality. Detecting previously undiagnosed AF in stroke patients is crucial for optimal secondary prevention through oral anticoagulation therapy.

As a result, guidelines emphasize the importance of AF screening in stroke patients to prevent recurrent strokes. Since AF can be asymptomatic and occur only intermittently, diagnosis may be easily missed or delayed. Studies have shown that prolonged screening increases detection rates. According to current knowledge, international AF and stroke guidelines recommend prolonged cardiac monitoring of at least 24 hours to detect subclinical AF if no other cause of stroke is identified.

However, while guidance exists on screening duration, none of the guidelines provide specific recommendations regarding the choice of device or the timing of screening. The sensitivity of AF detection likely depends on the screening strategy, timing, device, and algorithm used, but this area has been only minimally studied. Evidence suggests that the highest yield for AF detection may be early after stroke symptom onset. Nevertheless, significant knowledge gaps remain, and current screening strategies are not fully satisfactory.

Efforts to improve AF detection are warranted. This project aims to explore:

i. Whether prolonged AF screening initiated upon hospital admission after acute stroke results in a higher detection rate compared to prolonged ambulatory screening after discharge ii. Whether a 3-lead continuous ECG device has a higher detection rate compared to a 1-lead continuous patch recorder iii. A comparison of continuous vs. intermittent ECG AF screening for detection

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 years or older
  • Ischemic stroke
  • Without known AF or those with previously diagnosed paroxysmal AF exhibiting sinus rhythm upon admission

Exclusion Criteria

  • AF at hosptial admission
  • Unable or unwilling to provide informed consent
  • A life expectancy of less than one year

Outcomes

Primary Outcomes

Impact of timing: Atrial fibrillation detection rate

Time Frame: 48 to 96 hours

Detection rate of AF during initial in-hospital screening compared to detection rate during the second screening period starting at hospital discharge (ambulatory)

Secondary Outcomes

  • Impact of device: Atrial fibrilation detection rate in 1-lead vs. 3-lead ECG recorder(48 hours)
  • Impact of Continuity: Atrial fibrillation detection rate in continuous vs. intermittent ECG monitoring(72 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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