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SCREENING AFTER STROKE - ATRIAL FIBRILLATION

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06675383
Acronym
SAS-AF
Enrollment
410
Registered
2024-11-05
Start date
2024-11-01
Completion date
2033-12-31
Last updated
2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial fibrillation screening in acute stroke

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 The design involves a prospective observational trial of an unselected cohort of patients admitted with acute stroke to Bærum Hospital. Eligible participants include all patients above 18 years old without known AF or those with previously diagnosed paroxysmal AF exhibiting sinus rhythm upon admission. Upon admission to the Stroke Unit, patients will as soon as possible undergo a 48-hour in-hospital continuous heart monitoring, followed by a second 48-hour continuous heart monitoring upon discharge (ambulatory). In addition, an intermittent AF screening with hand held thumb ECG, will be performed 3 times a day for 30 seconds, and for 3 consecutive days during the hospital stay in a sample of the participants, and compared to detection rate with continues heart monitoring.

Interventions

None listed

Sponsors

Vestre Viken Hospital Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Impact of timing: Atrial fibrillation detection rate48 to 96 hoursDetection rate of AF during initial in-hospital screening compared to detection rate during the second screening period starting at hospital discharge (ambulatory)

Secondary

MeasureTime frameDescription
Impact of device: Atrial fibrilation detection rate in 1-lead vs. 3-lead ECG recorder48 hoursWill a 3-lead ECG device provide a higher detection rate compared to a 1-lead patch recorder when both devices are used in parallel on the same person
Impact of Continuity: Atrial fibrillation detection rate in continuous vs. intermittent ECG monitoring72 hoursWill 48-hour continuous ECG monitoring provide a higher AF detection rate compared to intermittent AF screening using a handheld thumb ECG performed three times daily for 30 seconds over three consecutive days during the hospital stay.

Countries

Norway

Contacts

Primary ContactHåkon Ihle-Hansen, MD PhD
haaihl@vestreviken.no0047-454-50633

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026