SCREENING AFTER STROKE - ATRIAL FIBRILLATION (SAS-AF)

November 4, 2024 updated by: Vestre Viken Hospital Trust

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

410

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
    • Gjettum
      • Sogneprest Munthe-kaas vei 100, Gjettum, Norway, 1346
        • Recruiting
        • Vestre Viken Hospital trust, Baerum Hospital
        • Contact:
        • Contact:
          • Håkon Ihle-Hansen, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute ischemic stroke
Admitted with acute ischemic stroke and absence of atrial fibrillation on admission.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
48 to 96 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of device: Atrial fibrilation detection rate in 1-lead vs. 3-lead ECG recorder
Time Frame: 48 hours
Will 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
48 hours
Impact of Continuity: Atrial fibrillation detection rate in continuous vs. intermittent ECG monitoring
Time Frame: 72 hours
Will 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.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vestre Viken Hospital Trust

Investigators

  • Study Director: Håkon Ihle-Hansen, MD PhD, Vestre Viken HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Estimated)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAS-AF study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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