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Hidden heart condition often missed after mini-stroke, study aims to find best detector

NCT ID NCT04075500

Knowledge-focused Sponsor: Alfried Krupp Krankenhaus 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two heart monitoring methods in 516 people who had a transient ischemic attack (TIA or mini-stroke). The goal was to see which method better detects hidden atrial fibrillation, a heart rhythm problem that raises stroke risk. Participants received either a small implanted heart monitor or a wearable patch for 28 days, and researchers tracked new atrial fibrillation cases over 6 months.

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 successful, this could establish a standard monitoring method to detect hidden atrial fibrillation in TIA patients, potentially preventing many strokes.
What could go wrong
This is an observational comparison of monitoring methods, not a treatment trial. It may not prove that better detection actually reduces strokes.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

516 people

The number who actually took part.

Started

Mar 2019

Finished

Aug 2025

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.

Ages

50 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.

Eligibility Criteria: Study Population Patients with a recent TIA will be enrolled during a period of approximately 24 months at participating European stroke centres. TIA patients may be enrolled after initial management as inpatients or outpatients. Consecutive screening and enrolment will be strongly encouraged and a screening log will be implemented at each site. Inclusion Criteria * Written informed consent by patient. * Age ≥ 50 years. * TIA diagnosed by a stroke physician defined as rapidly developing clinical signs of focal or global disturbances of cerebral function, lasting less than 24 hours with no apparent non-vascular cause * 12-channel ECG available before enrolment * Brain imaging available before enrolment (CCT or cranial MRI) * Vascular imaging of cervical vessels performed * Enrolment within 28 days after TIA episode. Exclusion Criteria * Previously documented history of AF * Ischemic stroke within the last 6 months before enrolment * Pre-screening monitoring for cardiac arrhythmias lasting ≥72 hours * AF lasting \> 30 s on a 12 channel ECG or other ECG recording technique prior to enrolment * Life expectancy less than 1 year. * Significant stenosis \> 50% in intracranial or extracranial vessels which, in the opinion of the investigator, is the likely cause of the patients TIA. * Severely disabled patients (i.e. modified Rankin Score \>3) * Lack of therapeutic consequence in case of diagnosis of AF (e.g. other indication for long term anticoagulation * Pacemaker or Implanted Cardiac Defibrillator

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Conditions

The condition(s) this trial relates to.

atrial fibrillation transient ischemic attack

As listed by the trial registrant

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

Atrial fibrillation Transient ischemic attack

Contacts and locations

Locations

  • Alfried Krupp Krankenhaus

    Essen, 45131, Germany

  • Bezirkskliniken Schwaben; Bezirkskrankenhaus Günzburg; Klinik für Neurologie

    Günzburg, 89312, Germany

  • Carl-Thiem-Klinikum Cottbus; Klinik für Neurologie

    Cottbus, 03048, Germany

  • Complejo Hospitalario Clinico Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006, Spain

  • Hospital Dr. Josep Trueta

    Girona, 17007, Spain

  • Hospital Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14011, Spain

  • Hospital Universitario Torrecárdenas

    Almería, 04009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41003, Spain

  • Hospital Universitario de Cruces

    Barakaldo, Bizkaia, 48903, Spain

  • Hospital Virgen Macarena

    Seville, 41009, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Klinikum Dortmund, Klinikzentrum Mitte / Neurologie

    Dortmund, 44137, Germany

  • Krankenhaus Marth-Maria-Halle-Dölau GmbH; Klinik für Neurologie

    Halle, 06120, Germany

  • RKU Universitäts- und Rehabilitationskliniken Ulm

    Ulm, 89081, Germany

  • Rhön Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale, 97616, Germany

  • Universität Leipzig, Medizinische Fakultät; Klinik und Poliklinik für Neurologie

    Leipzig, 04103, Germany

  • Universitätsklinik Heidelberg, Neurologie

    Heidelberg, 69120, Germany

  • Universitätsklinikum Aachen, Neurologie

    Aachen, 52074, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, 23538, Germany

  • Universitätsklinikum Tübingen; Neurologische Universitätsklinik; Abt. Neurologie mit Schwerpunkt vaskuläre Erkrankungen

    Tübingen, 72076, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Universitätsmedizin Frankfurt; Klinik für Neurologie;

    Frankfurt, 60590, Germany

  • Universitätsmedizin Halle; Universitätsklinikum Halle (Saale); Klinik und Poliklinik für Neurologie

    Halle, 06120, Germany

  • Vivantes Klinikum Neukölln

    Berlin, 12351, Germany

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