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

November 19, 2024 updated by: EMILIANO ROSSI, Hospital Italiano de Buenos Aires

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • C.a.b.a
      • Buenos Aires, C.a.b.a, Argentina, C1199
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 48-hr
48-hr electrocardiographic monitoring
Diagnostic test: 48-hr electrocardiographic monitoring
48-hr external electrocardiographic monitoring
Experimental: 7-day
7-day electrocardiographic monitoring
Diagnostic test: 7-day electrocardiographic monitoring
7-day external electrocardiographic monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation
Time Frame: 7 days
Detection of one episode of atrial fibrillation or atrial flutter >30 seconds up to 7 days
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: Gustavo Maid, MD, Hospital Italiano de Buenos Aires

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

October 7, 2021

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5767

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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