Clinical trial NCT06675383: SCREENING AFTER STROKE - ATRIAL FIBRILLATION
Official title: SCREENING AFTER STROKE - ATRIAL FIBRILLATION - the SIGNIFICANCE of TIMING and CHOICE of DEVICE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial fibrillation screening in acute stroke
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The design involves a prospective observational trial of an unselected cohort of patients admitted with acute stroke to Bærum Hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of timing: Atrial fibrillation detection rate
timeFrame: 48 to 96 hours
Secondary outcomes:
measure: Impact of device: Atrial fibrilation detection rate in 1-lead vs. 3-lead ECG recorder
timeFrame: 48 hours
measure: Impact of Continuity: Atrial fibrillation detection rate in continuous vs. intermittent ECG monitoring
timeFrame: 72 hours
Other outcomes:
Locations:
city: Sogneprest Munthe-kaas vei 100
country: Norway
facility: Vestre Viken Hospital trust, Baerum Hospital
state: Gjettum
Study officials:
affiliation: Vestre Viken HF
name: Håkon Ihle-Hansen, MD PhD
role: STUDY_DIRECTOR
References:
citation: Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
citation: Kamel H, Lees KR, Lyden PD, Teal PA, Shuaib A, Ali M, Johnston SC; Virtual International Stroke Trials Archive Investigators. Delayed detection of atrial fibrillation after ischemic stroke. J Stroke Cerebrovasc Dis. 2009 Nov-Dec;18(6):453-7. doi: 10.1016/j.jstrokecerebrovasdis.2009.01.012.
citation: Tu HT, Campbell BC, Christensen S, Desmond PM, De Silva DA, Parsons MW, Churilov L, Lansberg MG, Mlynash M, Olivot JM, Straka M, Bammer R, Albers GW, Donnan GA, Davis SM; EPITHET-DEFUSE Investigators. Worse stroke outcome in atrial fibrillation is explained by more severe hypoperfusion, infarct growth, and hemorrhagic transformation. Int J Stroke. 2015 Jun;10(4):534-40. doi: 10.1111/ijs.12007. Epub 2013 Mar 12.
citation: Sandercock P, Bamford J, Dennis M, Burn J, Slattery J, Jones L, Boonyakarnkul S, Warlow C. Atrial fibrillation and stroke: prevalence in different types of stroke and influence on early and long term prognosis (Oxfordshire community stroke project). BMJ. 1992 Dec 12;305(6867):1460-5. doi: 10.1136/bmj.305.6867.1460.
citation: Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
citation: Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features of chronic atrial fibrillation: the Framingham study. N Engl J Med. 1982 Apr 29;306(17):1018-22. doi: 10.1056/NEJM198204293061703.
citation: Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.