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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04644679
• Other study ID #: 5767
• Status: Terminated
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: October 7, 2021

Study information

• Verified date: November 2020
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: October 7, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Ischemic Stroke
• Stroke

Intervention

Diagnostic Test:
• 7-day electrocardiographic monitoring
7-day external electrocardiographic monitoring
• 48-hr electrocardiographic monitoring
48-hr external electrocardiographic monitoring

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires	C.a.b.a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation	Detection of one episode of atrial fibrillation or atrial flutter >30 seconds up to 7 days	7 days
Secondary	Supraventricular arrhythmia	Count of beats per day of non-sustained irregular atrial tachyarrhythmia or supraventricular extrasystoles up to 7 days	7 days