NCT04644679

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

48-hour Versus 7-day Monitoring for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Atrial Fibrillation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	7-day electrocardiographic monitoring	7-day external electrocardiographic monitoring
DIAGNOSTIC_TEST	48-hr electrocardiographic monitoring	48-hr external electrocardiographic monitoring

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-09-30
• Completion: 2021-10-07
• First posted: 2020-11-25
• Last updated: 2024-11-21

Locations

1 site across 1 country: Argentina

Regulatory

• FDA-regulated device study