Monitoring Strategies for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke

Not Applicable

Terminated

• Conditions: Stroke; Atrial Fibrillation
• Interventions: Diagnostic Test: 7-day electrocardiographic monitoring; Diagnostic Test: 48-hr electrocardiographic monitoring

• Registration Number: NCT04644679
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

Randomized clinical trial comparing two monitoring strategies, the use of a 48-hour Holter (routine care branch) and an event recorder for 7 days (intervention branch).

Patients admitted for cryptogenic stroke will be included. Enrollment and randomization of patients will be carried out during the index case hospitalization, while follow-up will be done on an outpatient basis until day 7.

Detailed Description

Once the diagnose of cryptogenic stroke have been carried out, informed consent will be taken and participants will be randomized to 48-hour monitoring arm or 7-day monitoring arm, followed by discharge from hospital.

Study Timeline

• Study First Submitted: 2020-09-30
• Status Verified: 2020-11
• Study Start: 2020-11-02
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-25
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-07
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• All patients who have studies that classify stroke or TIA as cryptogenic and who can carry out monitoring for 48 hours or 7 days will be included.
• Age ≥ 18 years

Exclusion criteria

• History of atrial fibrillation (or atrial flutter) documented.
• Patients who already have an event recorder in place, permanent pacemaker, or implantable cardioverter-defibrillator
• Evidence of lacunar infarction.
• Hemorrhagic stroke
• Patient for palliative care

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7-day	7-day electrocardiographic monitoring	7-day electrocardiographic monitoring
48-hr	48-hr electrocardiographic monitoring	48-hr electrocardiographic monitoring

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	7 days	Detection of one episode of atrial fibrillation or atrial flutter \>30 seconds up to 7 days

Secondary Outcome Measures

Name	Time	Method
Supraventricular arrhythmia	7 days	Count of beats per day of non-sustained irregular atrial tachyarrhythmia or supraventricular extrasystoles up to 7 days

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, C.a.b.a, Argentina