NCT07194811

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,400 (estimated)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2016-05-01
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: Norway