SCREENING AFTER STROKE - ATRIAL FIBRILLATION

NCT06675383 | Recruiting

• 1 other identifier: SAS-AF study
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial fibrillation screening in acute stroke

Outcome Measures

Primary Outcomes (1)

• Impact of timing: Atrial fibrillation detection rate

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

  48 to 96 hours

Secondary Outcomes (2)

• 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

Study Arms (1)

Acute ischemic stroke

Admitted with acute ischemic stroke and absence of atrial fibrillation on admission.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead

Study Sites (1)

Vestre Viken Hospital trust, Baerum Hospital

Sogneprest Munthe-kaas Vei 100, Gjettum, 1346, Norway

RECRUITING

Related Publications (7)

• 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.

  PMID: 32860505 BACKGROUND

• 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.

  PMID: 19900647 BACKGROUND

• 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.

  PMID: 23489996 BACKGROUND

• 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.

  PMID: 1493391 BACKGROUND

• 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.

  PMID: 24788967 BACKGROUND

• 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.

  PMID: 7062992 BACKGROUND

• 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.

  PMID: 24345399 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples to a study-specific biobank

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Håkon Ihle-Hansen, MD PhD

  Vestre Viken HF

  STUDY DIRECTOR

Central Study Contacts

Håkon Ihle-Hansen, MD PhD

CONTACT

0047-454-50633; haaihl@vestreviken.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2033
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

NO (1)