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NCT Number: NCT07194811

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

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cryptogenic Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolic Stroke Embolic Stroke of Undetermined Source Heart Diseases Implantable Cardiac Monitor Ischemic Stroke Nervous System Diseases Oral Anticoagulation Pathologic Processes Pathological Conditions, Signs and Symptoms Secondary Stroke Prevention Stroke Vascular Diseases Women's Health

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital, Department of Neurology

Oslo, Lørenskog/Akershus, 1478, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Atrial fibrillation deteceted after stroke and transient ischemic attack (TIA)

    Time frame: 30 days and 1 year after index stroke

    >30 seconds of atrial fibrillation detection using implantable cardiac monitor/implantable loop-recorder

  2. Recurrent ischemic stroke after 1 and 2 years

    Time frame: 30 days, 1 and 2 years after index stroke

    Ischemic stroke/TIA: Clinical diagnosis (TOAST criteria) verified by CT and/or MR.

Secondary outcomes

  1. Composite of stroke and mortality

    Time frame: 30 days, 1 and 2 years after index stroke

    Ischemic and heamorragic stroke, (ICD-10 I63 and I61) transient ischemic attack(TIA) (ICD10: G45.9) and mortality

  2. Intracranial bleeding

    Time frame: 30 days, 1 and 2 years after index stroke

    Symptomatic intracranial heamorrage (stroke) (ICD-10: I61)

  3. Patient Reported Outcome Measureres

    Time frame: 3 months after index stroke

    Self-perceived health and health related quality of life by using the EuroQol scale (EQ-5D-5L)

  4. Ischemic cardiac events

    Time frame: 1 and 2 years

    Hospitaized for ischemic cardiac events (ICD10 20-25)

  5. Safety outcome

    Time frame: 1 and 2 years after index stroke

    Hospitalized for gastrointestinal bleeding (ICD 10 K92) and/or intracranial bleeding (I61)

  6. Oral anticoagulation

    Time frame: 1 and 2 years

    Use of oral anticoagulation

  7. Functional outcome 3 months post-stroke

    Time frame: 3 months after index stroke

    Functional outcome 3 months post-stroke using modified Rankin Scale (mRS) from the national stroke registry

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Haukeland University Hospital
  • The Dam Foundation
  • The Norwegian Women´s Public Health Association
  • University of Oslo

Registry information

Official study title

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

Acronym: STROKEWISE

Important dates

Study start
2016
Primary completion
2023
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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