Atrial Fibrillation Screening Post Ischemic Cerebrovascular Events

ConditionsIschemic Stroke TIA

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age70+

SponsorKarolinska Institutet

About this trial

Stroke is one of the leading causes behind death and permanent disability in adults. Atrial fibrillation (AF) is the most common clinical arrhythmia and its prevalence is steeply increasing with age. Atrial fibrillation is associated with a manifold increase in the risk for stroke.

It is considered important to investigate the heart rhythm in stroke survivors without previously known AF, because detection of AF will prompt a change in antithrombotic treatment with subsequent lowering of the risk of recurrent stroke.

There are so far very few studies on the prognostic impact of ECG investigations post stroke. Despite this knowledge gap, ECG investigation post stroke is given high priority in national and international guidelines.

Considerable clinical resources are currently invested in these ECG investigations without knowledge of its utility.

The investigators plan a nationwide, randomised, register-based study (RRCT) including patients aged at least 70 years receiving in-hospital care for stroke or TIA (Transient Ischemic Attack). Included patients will be randomised to standard investigation (1-2 days of ECG ) or extended ECG investigation (14 days of ECG performed at least twice). Patients diagnosed AF will be offered anticoagulation treatment. Long-term follow-up will be performed via swedish health care registers.

The result of this trial will have major impact on the ECG screening recommendations for patients who have had stroke, a large group of patients with dismal prognosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥ 70 years

A diagnosis of ischemic stroke or TIA within 14 days from inclusion.

Disqualifiers

Previously diagnosed atrial fibrillation

Contraindication to oral anticoagulant treatment according to Summary of Product Characteristics.

Indication for anticoagulant treatment other than atrial fibrillation, e.g. venous thromboembolism or mechanical heart valve prosthesis

Dual antiplatelet therapy not interchangeable to oral anticoagulation

Trial design

Design model

Parallel

Treatments tested in this trial

Extended ECG investigation
Diagnostic test
At least two long-term ambulatory ECG recordings with a duration of 14 days each using Philips ePatch (https://www.myheartmonitor.com/device/epatch/). The two recordings should be 2-4 months apart.

Treatment groups

3,300 Participants

are divided into 2 treatment groups

Group A: Extended ECG investigationExperimental treatment 1 intervention

Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

Composite of stroke, death and intracerebral bleeding

Stroke is defined as the occurence of International Classification of Diseases (ICD) 10 codes I63 in swedish health care registers. Intracranial bleeding is defined as the occurence of ICD 10 codes I61 in swedish health care registers. Mortality is defined as death reported by the swedish registers on cause of death.

Time frame