Cryptogenic StrokeSTROKEWISENCT07194811
Stroke of Unknown Cause in Women: The Impact of Long-term Heart Monitoring on Stroke Recurrence
An observational study of Cryptogenic Stroke and Atrial Fibrillation, run by University Hospital, Akershus at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptogenic Stroke, Atrial Fibrillation, Implantable Cardiac Monitor
- How many people
- 1,400 participants
- Where
- 1 siteNorway
- Study dates
- May 2016to Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In total 1050 patients. A cohort of at least 700 patients of both sexes diagnosed with acute cryptogenic stroke or TIA and with an implantable cardiac monitor, admitted to the stroke unit at Akershus University Hospital, Norway. A control group of 350 women with acute cryptogenic stroke or TIA, with non-invasive standard monitoring, admitted to the stroke unit at Haukeland University Hospital.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Akershus University Hospital, Department of Neurology
Oslo, Lørenskog/Akershus, 1478
About this study
Official title: Stroke of Unknown Cause: The Impact of Long-term Heart Monitoring on Stroke Recurrence in Women
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?
Read the 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
- Keywords
- Cerebrovascular Disorder, Cardiovascular Disease, Cardiac arrhythmias, Stroke, Ischemic stroke, Atrial Fibrillation, Sex-differences, Women's Health, Secondary Stroke Prevention, Oral anticoagulation, Embolic stroke
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation, Cerebrovascular Disorders, Cardiovascular Diseases, Arrhythmias, Cardiac, Stroke, Embolic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICM group | Cryptogenic stroke/ESUS with insertable cardiac monitor for detection of atrial fibrillation | |
| Control group | Non- invasive monitoring and standard of care. Women with cryptogenic stroke(ESUS) from another hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation deteceted after stroke and transient ischemic attack (TIA)
>30 seconds of atrial fibrillation detection using implantable cardiac monitor/implantable loop-recorder
Measured: 30 days and 1 year after index stroke
Recurrent ischemic stroke after 1 and 2 years
Ischemic stroke/TIA: Clinical diagnosis (TOAST criteria) verified by CT and/or MR.
Measured: 30 days, 1 and 2 years after index stroke
Secondary outcomes (7)
Composite of stroke and mortality
Ischemic and heamorragic stroke, (ICD-10 I63 and I61) transient ischemic attack(TIA) (ICD10: G45.9) and mortality
Measured: 30 days, 1 and 2 years after index stroke
Intracranial bleeding
Symptomatic intracranial heamorrage (stroke) (ICD-10: I61)
Measured: 30 days, 1 and 2 years after index stroke
Patient Reported Outcome Measureres
Self-perceived health and health related quality of life by using the EuroQol scale (EQ-5D-5L)
Measured: 3 months after index stroke
Ischemic cardiac events
Hospitaized for ischemic cardiac events (ICD10 20-25)
Measured: 1 and 2 years
Safety outcome
Hospitalized for gastrointestinal bleeding (ICD 10 K92) and/or intracranial bleeding (I61)
Measured: 1 and 2 years after index stroke
Oral anticoagulation
Use of oral anticoagulation
Measured: 1 and 2 years
Functional outcome 3 months post-stroke
Functional outcome 3 months post-stroke using modified Rankin Scale (mRS) from the national stroke registry
Measured: 3 months after index stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study startMay 2016
- Primary completionDec 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cryptogenic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, The Dam Foundation, The Norwegian Women´s Public Health Association, University of Oslo
- Responsible party
- Principal investigator, Jannicke Koldaus-Falch, University Hospital, Akershus
- Investigators
- Ole Morten Rønning, Professor, Study director, Akerhus University Hospital and University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194811
- Sponsor's protocol ID
- 24/01445
- Acronym
- STROKEWISE
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Norwegian regulations, the data cannot be shared publicly, and the authors are not permitted to share the data or study materials used in this study. De-identified datasets may be made available from the corresponding author upon reasonable request and with appropriate ethical and institutional approvals.
Publications
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.
PubMed 35819199Koldeus-Falch J, Thommessen B, Sundseth A, Skrebelyte-Strom L, Naess H, Truscott Thomas OM, Ronning OM. Cryptogenic stroke in women: impact of insertable cardiac monitoring in the STROKEWISE cohort study. Europace. 2026 Mar 30;28(4):euag056. doi: 10.1093/europace/euag056.
PubMed 41870212
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke of Unknown Cause: The Impact of Long-term Heart Monitoring on Stroke Recurrence in Women
- ClinicalTrials.gov ID
- NCT07194811
- Acronym / sponsor ID
- STROKEWISE / 24/01445
- Conditions
- Cryptogenic Stroke, Atrial Fibrillation, Implantable Cardiac Monitor, Secondary Stroke Prevention, Women's Health, Embolic Stroke of Undetermined Source
- Keywords
- Cerebrovascular Disorder, Cardiovascular Disease, Cardiac arrhythmias, Stroke, Ischemic stroke, Atrial Fibrillation, Sex-differences, Women's Health
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, The Dam Foundation, The Norwegian Women´s Public Health Association, University of Oslo
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICM group | – | –Cryptogenic stroke/ESUS with insertable cardiac monitor for detection of atrial fibrillation |
| Control group | – | –Non- invasive monitoring and standard of care. Women with cryptogenic stroke(ESUS) from another hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In total 1050 patients. A cohort of at least 700 patients of both sexes diagnosed with acute cryptogenic stroke or TIA and with an implantable cardiac monitor, admitted to the stroke unit at Akershus University Hospital, Norway. A control group of 350 women with acute cryptogenic stroke or TIA, with non-invasive standard monitoring, admitted to the stroke unit at Haukeland University Hospital.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
7 secondary outcomes
Composite of stroke and mortality
Time frame: 30 days, 1 and 2 years after index stroke
Intracranial bleeding
Time frame: 30 days, 1 and 2 years after index stroke
Patient Reported Outcome Measureres
Time frame: 3 months after index stroke
Ischemic cardiac events
Time frame: 1 and 2 years
Safety outcome
Time frame: 1 and 2 years after index stroke
Oral anticoagulation
Time frame: 1 and 2 years
Functional outcome 3 months post-stroke
Time frame: 3 months after index stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 35819199Skrebelyte-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.
- Derived from this study: PubMed 41870212Koldeus-Falch J, Thommessen B, Sundseth A, Skrebelyte-Strom L, Naess H, Truscott Thomas OM, Ronning OM. Cryptogenic stroke in women: impact of insertable cardiac monitoring in the STROKEWISE cohort study. Europace. 2026 Mar 30;28(4):euag056. doi: 10.1093/europace/euag056.
- Individual participant dataSharing planned: No. Due to Norwegian regulations, the data cannot be shared publicly, and the authors are not permitted to share the data or study materials used in this study. De-identified datasets may be made available from the corresponding author upon reasonable request and with appropriate ethical and institutional approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Morten Rønning, Professor study director
Akerhus University Hospital and University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptogenic Stroke and Atrial Fibrillation, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation deteceted after stroke and transient ischemic attack (TIA) (time frame: 30 days and 1 year after index stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07194811, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.