Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs to detect Atrial Fibrillatio

Completed

• Conditions: atrial fibrillation; 10007521

• Registration Number: NL-OMON42745
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-11-09
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 57

Inclusion Criteria

Patient with cryptogenic stroke
Patient with cryptogenic TIA

Exclusion Criteria

- Known etiology of TIA or stroke
- Myocardial infarction <6 months before stroke
- Coronary Artery Bypass Grafting <6 months before stroke
- Severe valvular heart disease
- Documented history of atrial fibrillation or atrial flutter
- Permanent indication for oral anticoagulation at enrolment
- Patient has permanent OAC contraindication
- Patient is included in another randomized trial
- Left ventricular aneurysm on echocardiography
- Thrombus on echocardiographyRenal dysfunction (creatinine clearance <30 mL/min/1.73m2)
- Patient has life expectancy of <1 year
- Patient is not willing to sign the informed consent form
- Patient is <18 years of age
- Patient is considered a incapacitated adult
- Patient is not in possession of a smartphone with Android Operating System (OS) or iOS.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint will be the percentage of detected atrial fibrillation in<br /><br>both the AliveCor group and the 7-Day Holter group after one year.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Pro-BNP levels in all patients within 24 hours after cryptogenic stroke<br /><br>- Percentages of atrial ectopy detected on the 7-day Holter monitor<br /><br>- Left atrial diameter and volume<br /><br>- Recurrent stroke<br /><br>- Major bleeding</p><br>