Atrial Fibrillation Screening Post Ischemic Cerebrovascular Events

NCT05134454 | Recruiting DMC

• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke; TIA

Keywords

stroke; TIA; atrial fibrillation; ECG; oral anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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.

  at least 36 months of follow-up (study event driven)

Secondary Outcomes (8)

• Individual components of the primary endpoint

  at least 36 months of follow-up (study event driven)

• Major bleeding

  at least 36 months of follow-up (study event driven)

• Myocardial infarction

  at least 36 months of follow-up (study event driven)

• Pacemaker implantation

  at least 36 months of follow-up (study event driven)

• Anticoagulation treatment

  at least 36 months of follow-up (study event driven)

Study Arms (2)

Extended ECG investigation

EXPERIMENTAL

Participants will undergo 0-48 hours of continuous ECG recording and at least two long-term continuous ambulatory ECG recordings with a duration of 14 days each.

Diagnostic Test: Extended ECG investigation

Standard of care

NO INTERVENTION

Participants will undergo 24-48 hours of continuous ECG recording.

Interventions

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.

Extended ECG investigation

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged ≥ 70 years

You may not qualify if:

• 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
• Patients with pacemaker, implantable cardioverter defibrillator or implantable cardiac monitor.
• Patients who, according to the investigator, will not be able to comply with the study protocol.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Uppsala University: collaborator
• Örebro University, Sweden: collaborator
• Lund University: collaborator
• Umeå University: collaborator
• The Swedish Research Council: collaborator
• Swedish Heart Lung Foundation: collaborator

Study Sites (1)

Karolinska Institutet Danderyds University Hospital

Stockholm, 18288, Sweden

RECRUITING

Related Publications (1)

• Engdahl J, Straat K, Isaksson E, Rooth E, Svennberg E, Norrving B, Euler MV, Hellqvist K, Gu W, Strom JO, Sjalander S, Eriksson M, Asberg S, Wester P. Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the effect on stroke, death and intracerebral bleeding: the AF SPICE protocol. BMJ Open. 2023 Nov 23;13(11):e073470. doi: 10.1136/bmjopen-2023-073470.

  PMID: 37996238 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johan Engdahl, MD, PhD

  Karolinska Institutet

  STUDY CHAIR

Central Study Contacts

Johan Engdahl, MD, PhD

CONTACT

+46737593374; johan.engdahl@sll.se

Kajsa Strååt, MD

CONTACT

+46812350000; kajsa.straat@sll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior consultant

Model Details: multicenter, national, investigator-initiated, randomized, parallel-group, register based superiority study

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: November 26, 2021
• Study Start: January 20, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From conclusion of inclusion in 2025 to 2035
• Access Criteria: Data available to researchers with own similar data or as part of metaanalysis.

Locations

SE (1)