Actively Recruiting

Phase Not Applicable
Age: 50Years - 89Years
All Genders
NCT06542770

Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke

Led by Parc de Salut Mar · Updated on 2024-08-07

100

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF. The purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.

CONDITIONS

Official Title

Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke

Who Can Participate

Age: 50Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023
  • Age between 50 and 89 years
  • Undetermined stroke origin at hospital admission by SSS-TOAST criteria
  • No major structural heart disease by cardiac ultrasound
  • No atrial fibrillation during 48-hour ECG monitoring
  • No major anomalies in supra-aortic trunk ultrasound
Not Eligible

You will not qualify if you...

  • History of hemorrhagic stroke
  • Prior atrial fibrillation or atrial flutter
  • Permanent contraindication or indication for oral anticoagulation for other reasons
  • Major surgery or cardiac events within the last month
  • Severe cardiac abnormalities
  • Life expectancy less than 1 year or severe stroke (modified Rankin Scale greater than 4)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital del Mar

Barcelona, Spain, 08003

Actively Recruiting

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Research Team

E

Ermengol Valles Gras, PhD

CONTACT

A

Ana Beatriz Garcia Duran, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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