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

NCT ID: NCT04644679

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2021-10-07

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.

Conditions

Stroke; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

48-hr

48-hr electrocardiographic monitoring

Group Type: ACTIVE_COMPARATOR

48-hr electrocardiographic monitoring

Intervention Type: DIAGNOSTIC_TEST

48-hr external electrocardiographic monitoring

7-day

7-day electrocardiographic monitoring

Group Type: EXPERIMENTAL

7-day electrocardiographic monitoring

Intervention Type: DIAGNOSTIC_TEST

7-day external electrocardiographic monitoring

Interventions

7-day electrocardiographic monitoring

7-day external electrocardiographic monitoring

Intervention Type: DIAGNOSTIC_TEST

48-hr electrocardiographic monitoring

48-hr external electrocardiographic monitoring

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Italiano de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

EMILIANO ROSSI

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustavo Maid, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

Hospital Italiano de Buenos Aires

Buenos Aires, C.a.b.a, Argentina

Countries

Argentina

Other Identifiers

5767

Identifier Type: -

Identifier Source: org_study_id