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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04644679

Enrollment

Registered

2020-11-25

Start date

2020-11-02

Completion date

2021-10-07

Last updated

2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

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.

Interventions

DIAGNOSTIC_TEST7-day electrocardiographic monitoring

7-day external electrocardiographic monitoring

DIAGNOSTIC_TEST48-hr electrocardiographic monitoring

48-hr external electrocardiographic monitoring

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Atrial fibrillation	7 days	Detection of one episode of atrial fibrillation or atrial flutter \>30 seconds up to 7 days

Secondary

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

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026