Stroke of Unknown Cause in Women: The Impact of Long-term Heart Monitoring on Stroke Recurrence

NCT ID: NCT07194811

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this observational study is to investigate sex - differences in detection rate of atrial fibrillation after cryptogenic stroke (embolic stroke of unknown cause) - using an implantable cardiac rhythm monitor - and the treatment effects of oral anticoagulation on recurrent stroke, ischemic cardiovascular events, major bleeding risk, disability and mortality.

The main questions to answer are:

• Is long-term monitoring and detection of atrial fibrillation after stroke of unknown cause in women related to recurrent stroke and disability?
• Is long-term monitoring and initiation of oral anticoagulation related to cardiovascular events and intracranial haemorrhages? And in addition increased in women compared to men?
• Is long-term rhythm monitoring after stroke with unknown cause related to patient reported outcomes in women?

Detailed Description

This is a prospective, observational, study including consecutive patiens with acute cryptogenic stroke /embolic stroke of unknown source (ESUS) or transient ischemic attack (TIA) admitted between 2016 and 2023 at Akershus University Hospital (AUH). As part of the standard investigation at AUH, selected patients are offered an implantable cardiac monitor (ICM) and followed up for detection of atrial fibrillation (AF) by a specialised neurocardiology team. A control group recruited at another hospital during the same period, Haukeland University Hospital (HUS), only comprise women.

The primary objectives:

• To investigate among women with stroke of unknown cause, the effect of implantable cardiac monitors compared to standard non-invasive approach on AF detection, recurrent stroke, death and disability.
• To investigate sex- differences in patients with stroke of unknown cause, the effect of implantable cardiac monitors on AF detection, recurrent stroke, death and disability.

Secondary objectives:

• To compare the rate of cardiovascular events and intracranial haemorrhages after stroke of unknown cause in women offered implantable cardiac monitors, compared to best standard non-invasive follow up
• To investigate the impact of implantable cardiac monitors on the use of oral anticoagulation in women
• To investigate self-perceived health and health related quality of life after stroke of unknown cause in women offered implantable loop recorders, compared to women offered best standard non-invasive approach to detect AF

Conditions

Cryptogenic Stroke; Atrial Fibrillation; Implantable Cardiac Monitor; Secondary Stroke Prevention; Women's Health; Embolic Stroke of Undetermined Source; Oral Anticoagulation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ICM group

Cryptogenic stroke/ESUS with insertable cardiac monitor for detection of atrial fibrillation

No interventions assigned to this group

Control group

Non- invasive monitoring and standard of care. Women with cryptogenic stroke(ESUS) from another hospital

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with cryptogenic stroke or TIA, according to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification and an implantable cardiac rythm monitor (ICM) for the ICM group not the control

Exclusion Criteria

• Patients with known or newly detected AF on standard ECG or 24 h Holter ECG.
• Patients on oral anticoagulants (OAC) for non-AF indications
• Patients with strong contraindications for OAC
• Severe cognitive impairment or disability or with a short life expectancy due to comorbidities of less than two years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

The Dam Foundation

OTHER

Sponsor Role: collaborator

The Norwegian Women´s Public Health Association

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Jannicke Koldaus-Falch

Neurologist and PhD- candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ole Morten Rønning, Professor

Role: STUDY_DIRECTOR

Akerhus University Hospital and University of Oslo

Locations

Akershus University Hospital, Department of Neurology

Oslo, Lørenskog/Akershus, Norway

Countries

Norway

References

Skrebelyte-Strom L, Ronning OM, Dahl FA, Steine K, Kjekshus H. Prediction of occult atrial fibrillation in patients after cryptogenic stroke and transient ischaemic attack: PROACTIA. Europace. 2022 Dec 9;24(12):1881-1888. doi: 10.1093/europace/euac092.

Reference Type: BACKGROUND

PMID: 35819199 (View on PubMed)

Other Identifiers

24/01445

Identifier Type: -

Identifier Source: org_study_id