Our hypothesis is that the 30 day PPG based AF detection algorithm is at least equivalent to the 3 day Holter evaluation for the detection of paroxysmal atrial fibrillation
ID
Bron
Verkorte titel
Aandoening
ischemic stroke
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
Rationale
Among patients suffering from stroke or transient ischemic attack 19-33% is newly diagnosed or had a history of AF. In three randomized controlled trials, AF was found between 8 and 22 percent of patients with a cryptogenic stroke, using invasive or non-invasive monitoring. Early detection and adequate treatment of silent AF decreases the stroke risk in these patients. Appropriate screening of patients after stroke can be time consuming and difficult to arrange. Over the last years technology in wearables has improved which enables the patient to perform heart rhythm registrations in a non-clinical setting
Objective
The aim of this study is to evaluate the feasibility of PPG to detect episodes of atrial fibrillation in ischemic stroke survivors and compare it to usual care using a 3 day Holter monitoring.
Study Design
The study is a prospective cohort analysis.
Study population
The patients enrolled in this study are adults, above the age of 18 years, who are evaluated for a cardiac embolic source after having suffered a cryptogenic stroke.
Intervention
In addition to a standard 3-day Holter, stroke patients will be asked to perform an automated PPG measurement on their own smartphone two times a day, for 90 seconds for 30 days.
Main outcome measurement
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
Doel van het onderzoek
Our hypothesis is that the 30 day PPG based AF detection algorithm is at least equivalent to the 3 day Holter evaluation for the detection of paroxysmal atrial fibrillation
Onderzoeksopzet
admission and 3 months
Onderzoeksproduct en/of interventie
Performing a PPG readout two times a day, during 90 seconds, with the own smartphone for 30 days.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
haemorrhagic stroke, lacunar infarction, known atrial fibrillation, other known cause of the ischemic stroke, inability to use a smartphone and language barrier.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8680 |
| Ander register | ACWO OLVG : WO 19.097 |