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

H

Hospital Italiano de Buenos Aires

Status

Terminated

Conditions

Atrial Fibrillation
Stroke

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

48-hr
Active Comparator group
Description:
48-hr electrocardiographic monitoring
Treatment:
Diagnostic Test: 48-hr electrocardiographic monitoring
7-day
Experimental group
Description:
7-day electrocardiographic monitoring
Treatment:
Diagnostic Test: 7-day electrocardiographic monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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