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Hidden heart rhythm disorder may be behind many unexplained strokes

NCT ID NCT01025947

Knowledge-focused Sponsor: University of Valencia Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study looks at people who had a stroke or mini-stroke with no known cause (cryptogenic stroke). Researchers want to see if a small device implanted under the skin, called an implantable loop recorder, can detect hidden atrial fibrillation — an irregular heart rhythm that can cause strokes — over two years. The goal is to understand how often atrial fibrillation occurs in these patients and whether it leads to changes in treatment.

What this could mean

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

What this could lead to
If this study finds that many cryptogenic strokes are linked to hidden atrial fibrillation, it could lead to better detection and prevention of future strokes.
What could go wrong
This is an observational study, not a treatment trial. It may not prove that detecting AF changes outcomes, and the device may miss some episodes.

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 100 people

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

Start date

Mar 2009

Finished

Mar 2013

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

Patients with cryptogenic stroke (TOAST criteria) and with an implantable EKG loop recorder implanted for detection of atrial fibrillation

Ages

45 to 85 years

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: * All patients included must meet one of these two conditions: * Patient presenting with an episode of transient ischemic attack (TIA) of cryptogenic origin with neurological symptoms of less than 24h of evolution and negative neuroimaging. * First episode of ischaemic stroke with cryptogenic etiology following TOAST criteria * All patients must meet all of the following: * The patient has been implanted an ILR within 30 days after qualifying event * Age between 45-85 years * No stenosis \>50% in any arterial vessel corresponding to the affected territory * Normal Echocardiography * Normal 24 hours EKG Holter recording * Absence of Patent Foramen Ovale through transcranial doppler (or transesophageal echocardiography) * Acceptance and signature of Patient Informed Consent. Exclusion Criteria: * All patients included cannot meet any of the following conditions: * Recurrent stroke or TIA * Stroke or TIA with determined etiology according to TOAST criteria. * Anticoagulation indication at the time of enrollment in the study. * Total contraindication for anticoagulation therapy * Atrial fibrillation detection prior to enrollment * Severe cognitive impairment or dementia * Patient unable to be followed up * Patients enrolled in another clinical trial * Patients with life expectancy of less than 1 year * Pregnancy

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Conditions

The condition(s) this trial relates to.

atrial fibrillation 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 Stroke

Contacts and locations

Locations

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

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