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Detection of paroxysmal atrial fibrillation using an automated Photo-plethysmography based artificial intelligence algorithm in ischemic stroke survivors

Detection of paroxysmal atrial fibrillation using an automated Photo-plethysmography based artificial intelligence algorithm in ischemic stroke survivors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23955
Enrollment
100
Registered
2020-05-20
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke

Interventions

Performing a PPG readout two times a day, during 90 seconds, with the own smartphone for 30 days.

Sponsors

Bayer
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: haemorrhagic stroke, lacunar infarction, known atrial fibrillation, other known cause of the ischemic stroke, inability to use a smartphone and language barrier.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
The following parameters will be collected to complete data analysis. - Demographic characteristics: age, sex, cardiovascular risk factors - Baseline NIHSS-score - Type of reperfusion therapy - CHADSVASC score - Stroke characteristics (e.g. stroke localisation, TIA or ischemic stroke) - Diagnosis and duration of PAF - The use of antiplatelets or anticoagulants

Contacts

Public ContactFemke Dessens

OLVG

f.m.dessens@olvg.nl020 5108780

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)