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Prevention study for Ischemic Stroke, Cryptogenic
Official title Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke
ClinicalTrials.gov ID: NCT06005233
What this study is testing
- What it's testing
- Scientific Background: In secondary prevention of ischemic stroke, detection of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent stroke by approximately 60%. Prolonged electrocardiogram (ECG) monitoring up to 6 months significantly increases detection of AFib in cryptogenic stroke.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Implanted Event Recorder with telemedicinal function (e.g., Biotronik BioMon 3m ProMRI HomeMon or similar)
- Cryptogenic stroke (within the last six month) after full standard evaluation:
- Stroke detected by computed tomography (CT) or magnetic resonance imaging (MRI) that is not lacunar (lacunar is defined as a subcortical infarct in...
- Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia
- No major-risk cardioembolic source of embolism (i.e., no permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intracardiac...
You likely can't join if
- Patient is not able to perform 1-lead ECG recording with smartwatch
- Patient possesses no smartphone (iOS version ≥10.0 or Android)
- Implanted pacemaker or cardioverter defibrillator (ICD)
- Pregnancy and breastfeeding period
See the full eligibility criteria
- Implanted Event Recorder with telemedicinal function (e.g., Biotronik BioMon 3m ProMRI HomeMon or similar)
- Cryptogenic stroke (within the last six month) after full standard evaluation:
- Stroke detected by computed tomography (CT) or magnetic resonance imaging (MRI) that is not lacunar (lacunar is defined as a subcortical infarct in the distribution of the small, penetrating cerebral arteries whose...
- Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia
- No major-risk cardioembolic source of embolism (i.e., no permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intracardiac thrombus, prosthetic cardiac valve, atrial myxoma or other cardiac tumors...
- No other specific cause of stroke identified (e.g., arteritis, dissection, migraine, vasospasm, drug abuse)
- No paroxysmal atrial fibrillation in 72h of in-hospital ECG-monitoring, including at least one Holter- ECG for 24 hours.
- Cryptogenic TIA with definite cortical syndrome (aphasia, neglect or homonymous hemianopia) (within the last six month) after full standard evaluation (see above)
- Age: ≥40 yrs.
- At least one of the following risk factors:
- CHA2DS2VASc score ≥4
- Atrial runs
- Left atrial size \> 45mm
- Left atrial appendage flow ≤ 0.2m/s
- No contraindication for anticoagulant therapy after acute phase of stroke
- Written informed consent by patient or authorized caregiver
- Patient is not able to perform 1-lead ECG recording with smartwatch
- Patient possesses no smartphone (iOS version ≥10.0 or Android)
- Implanted pacemaker or cardioverter defibrillator (ICD)
- Pregnancy and breastfeeding period
The study team makes the final eligibility decision.
Where it's taking place
- Munich, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Munich, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.