Can blood tests predict stroke risk in silent atrial fibrillation?
NCT ID NCT07713615
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This observational study investigates whether blood clotting markers and heart ultrasound measurements can help assess stroke risk in people with device-detected atrial fibrillation—a brief, symptomless irregular heart rhythm picked up by pacemakers or similar implants. Researchers will compare 111 participants with this condition to 111 matched controls without it, following them for up to 10 years. The goal is to better understand who might benefit from blood-thinning medication, which reduces stroke risk but increases bleeding risk.
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 research could lead to better ways to identify which patients with device-detected atrial fibrillation are at highest risk of stroke and would benefit most from blood-thinning medication.
- What could go wrong
- This is an observational study, not a treatment trial, so it cannot directly prove that any new approach reduces strokes. The findings may not change current practice without further validation.
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
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About 222 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Sep 2037
An estimate. End dates often move.
- Lead sponsor
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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
Participants will be recruited from the Department of Cardiology, Esbjerg and Grindsted Hospital, University Hospital of Southern Denmark. The study population comprises adults with implanted cardiac devices undergoing routine outpatient device interrogation. The device-detected atrial fibrillation cohort will include participants with at least one episode of device-detected atrial fibrillation lasting ≥1 minute identified during routine device interrogation within the previous 12 months. The control cohort will comprise participants without device-detected atrial fibrillation during the previous 4 years, recruited from the same outpatient population and matched on age, sex, and indication for cardiac device implantation. All participants will be enrolled consecutively from a single-center cardiology outpatient clinic.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age \> 50 years at inclusion * Implanted cardiac device with an atrial electrode * ≥1 episode of device-detected atrial fibrillation lasting ≥1 minute, detected at routine cardiac device interrogation within the last 12 months * Written informed consent obtained prior to inclusion Exclusion Criteria: * History of ECG-documented atrial fibrillation at any time prior to inclusion * Use of oral anticoagulation or dual antiplatelet therapy within 6 months prior to inclusion, irrespective of indication * Current treatment with oral contraceptives or hormone replacement therapy * Pregnancy or breastfeeding * End-stage renal disease (creatinine clearance \<15 mL/min, calculated using the Cockcroft-Gault equation) * Active malignancy, defined as cancer diagnosis not followed by curative treatment within 6 months of diagnosis * Major surgery within the last 3 months * Connective tissue disease requiring treatment * Acute coronary syndrome, stroke/transient ischemic attack, or venous thromboembolism within 3 months prior to inclusion * Known thrombophilia * Clinically significant hepatic or hematological disease requiring treatment and/or specialist follow-up * Mechanical heart valve, moderate-to-severe mitral stenosis, or other valvular disease requiring intervention
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Cardiology, Esbjerg and Grindsted Hospital, Southwest Denmark
RECRUITINGEsbjerg, 6700, Denmark
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