Detection of paroxysmal atrial fibrillation using an automated Photo-plethysmography based artificial intelligence algorithm in ischemic stroke survivors
- Conditions
- ischemic stroke
- Registration Number
- NL-OMON23955
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Adults, 18 years and above, cryptogenic stroke < 3 months evaluated for a possible cardiac embolic source and not previously diagnosed with atrial fibrillation at the time of inclusion.
Cryptogenic stroke is defined as; 1) an ischemic stroke or transient ischemic attack (TIA) that is not lacunar, 2) absence of extracranial or intracranial atherosclerosis causing luminal stenosis, 3) no definite source of cardioembolism and 4) No other specific cause of stroke identified (e.g. arteritis, dissection, migraine/vasospasm, drug abuse)
Exclusion Criteria
haemorrhagic stroke, lacunar infarction, known atrial fibrillation, other known cause of the ischemic stroke, inability to use a smartphone and language barrier.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the accuracy and feasibility of a 30-day PPG based smartphone AF detection algorithm in cryptogenic stroke patients and compare it to the standard of care using a 3-day Holter measurement
- Secondary Outcome Measures
Name Time Method The following parameters will be collected to complete data analysis.<br>- Demographic characteristics: age, sex, cardiovascular risk factors<br>- Baseline NIHSS-score<br>- Type of reperfusion therapy<br>- CHADSVASC score<br>- Stroke characteristics (e.g. stroke localisation, TIA or ischemic stroke)<br>- Diagnosis and duration of PAF<br>- The use of antiplatelets or anticoagulants <br>