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

NCT07194811 | Active Not Recruiting

• 1 other identifier: 24/01445
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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?

Conditions

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

Keywords

Cerebrovascular Disorder; Cardiovascular Disease; Cardiac arrhythmias; Stroke; Ischemic stroke; Atrial Fibrillation; Sex-differences; Women's Health; Secondary Stroke Prevention; Oral anticoagulation; Embolic stroke

Outcome Measures

Primary Outcomes (2)

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

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

  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.

  30 days, 1 and 2 years after index stroke

Secondary Outcomes (7)

• Composite of stroke and mortality

  30 days, 1 and 2 years after index stroke

• Intracranial bleeding

  30 days, 1 and 2 years after index stroke

• Patient Reported Outcome Measureres

  3 months after index stroke

• Ischemic cardiac events

  1 and 2 years

• Safety outcome

  1 and 2 years after index stroke

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Haukeland University Hospital: collaborator
• The Dam Foundation: collaborator
• The Norwegian Women´s Public Health Association: collaborator
• University of Oslo: collaborator

Study Sites (1)

Akershus University Hospital, Department of Neurology

Oslo, Lørenskog/Akershus, 1478, Norway

Location

Related Publications (1)

• 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.

  PMID: 35819199 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation; Cerebrovascular Disorders; Cardiovascular Diseases; Arrhythmias, Cardiac; Stroke; Embolic Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ole Morten Rønning, Professor

  Akerhus University Hospital and University of Oslo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist and PhD- candidate

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: May 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)