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Hidden heart problem may cause strokes in women – study tests new monitoring

NCT ID NCT07194811

Knowledge-focused Sponsor: University Hospital, Akershus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 1,400 women who had a stroke with no known cause. Researchers use a small implantable heart monitor to check for hidden atrial fibrillation, an irregular heartbeat that can cause strokes. The goal is to see if detecting this condition and using blood thinners can lower the risk of another stroke or disability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
implantable cardiac monitor
What this could lead to
If successful, this study could show that long-term heart monitoring helps detect hidden atrial fibrillation in women, potentially guiding better stroke prevention strategies.
What could go wrong
This is an observational study, not a randomized trial, so it cannot prove cause and effect. Results may not apply to all stroke patients, and monitoring may not reduce stroke recurrence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2016

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation cardiovascular disorder cerebrovascular disorder Embolic Stroke intracranial embolism Ischemic Stroke stroke disorder transient ischemic attack

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Cryptogenic stroke Embolic stroke of undetermined source Implantable cardiac monitor Oral anticoagulation Secondary stroke prevention Women'S health

Contacts and locations

Locations

  • Akershus University Hospital, Department of Neurology

    Oslo, Lørenskog/Akershus, 1478, Norway

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