Actively Recruiting

Phase Not Applicable
Age: 50Years - 89Years
All Genders
ID06542770

Subtle Ultrasound Atrial Anomalies Predict Early Silent Atrial Fibrillation with Implantable Cardiac Monitor in Cryptogenic Stroke Patients A Randomized Trial

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

100

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cryptogenic stroke (CS) causes about 30% of stroke unit admissions and often has an unknown cause. Silent paroxysmal atrial fibrillation (PAF) is believed to underlie many CS cases. This study evaluates the usefulness of implantable cardiac monitors (ICM) for early detection of silent PAF in patients with CS. The study also explores clinical and ultrasound predictors, such as atrial contraction strain (ACS), to identify patients at higher risk who may need closer monitoring. Patients admitted with CS are randomized within 48 hours of admission to either standard care or early ICM implantation before discharge. The ICM devices are implanted subcutaneously in the chest and programmed to detect atrial fibrillation episodes lasting 30 seconds or more. The study also uses cardiac ultrasound to assess atrial features like left atrial volume and strain to classify patients as having atrial cardiomyopathy or not. Standard care includes continuous ECG monitoring for at least 48 hours and follow-up ECGs and Holter monitoring. Participants undergo neurological exams, ECGs, brain imaging, and blood tests during admission and are followed up in outpatient clinics at 3, 6, 12 months, and every 6 months thereafter up to 2 years. Researchers will monitor for atrial fibrillation detection confirmed by ECG or device recordings, assess ultrasound predictors of PAF, and track stroke recurrence. All ICM recordings are reviewed by specialists, and oral anticoagulation is started if atrial fibrillation is detected.

CONDITIONS

Brief 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...

  • Adults aged between 50 and 89 years
  • Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023
  • Undetermined stroke origin at hospital admission according to SSS-TOAST criteria
  • No major structural heart disease by cardiac ultrasound
  • No atrial fibrillation detected 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 diagnosis of atrial fibrillation or atrial flutter
  • Permanent contraindication or other indication for oral anticoagulation
  • Recent 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 days after stroke

Participants undergo comprehensive evaluations including cardiac ultrasound to identify atrial cardiomyopathy and baseline assessments before randomization.

1 visit (in-person) before randomization

Implementation

Duration - Up to 2 years

Participants randomized to the intervention group receive an implantable cardiac monitor (ICM) 3-4 days after stroke before discharge, with remote monitoring for atrial fibrillation detection.

ICM implantation visit plus monthly remote monitoring and outpatient visits at 3, 6, 12 months and every 6 months thereafter

Monitoring

Duration - Up to 2 years

Participants in the control group receive standard care with serial ECGs during hospital stay and outpatient ECGs plus 72-hour Holter monitoring to detect atrial fibrillation.

Daily ECGs during hospital stay, outpatient ECGs at 3, 6, 12 months and every 6 months thereafter, and 1 scheduled 72-hour Holter monitoring

Long-term Monitoring

Duration - Up to 2 years

All participants are followed for up to 2 years to detect atrial fibrillation and stroke recurrence through scheduled visits and monitoring.

Outpatient visits at 3, 6, 12 months and every 6 months thereafter

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

A

Ana Beatriz Garcia Duran, MD

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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Published Research Related To This Trial

The prevalence, impact and economic implications of atrial fibrillation in stroke: what progress has been made?

Nadine E Andrew, Amanda G Thrift, Dominique A Cadilhac

https://pubmed.ncbi.nlm.nih.gov/23364221

Diagnosis of atrial fibrillation after stroke and transient ischaemic attack: a systematic review and meta-analysis.

Luciano A Sposato, Lauren E Cipriano, Gustavo Saposnik...

https://pubmed.ncbi.nlm.nih.gov/25748102

European Stroke Organisation (ESO) guideline on screening for subclinical atrial fibrillation after stroke or transient ischaemic attack of undetermined origin.

Marta Rubiera, Ana Aires, Kateryna Antonenko...

https://pubmed.ncbi.nlm.nih.gov/36082257

Ultra-early continuous cardiac monitoring improves atrial fibrillation detection and prognosis of patients with cryptogenic stroke.

E Cuadrado-Godia, B Benito, A Ois...

https://pubmed.ncbi.nlm.nih.gov/31424609

Antithrombotic treatment for secondary prevention of stroke and other thromboembolic events in patients with stroke or transient ischemic attack and non-valvular atrial fibrillation: A European Stroke Organisation guideline.

Catharina Jm Klijn, Maurizio Paciaroni, Eivind Berge...

https://pubmed.ncbi.nlm.nih.gov/31984228

Heart Rhythm Monitoring Strategies for Cryptogenic Stroke: 2015 Diagnostics and Monitoring Stroke Focus Group Report.

Gregory W Albers, Richard A Bernstein, Johannes Brachmann...

https://pubmed.ncbi.nlm.nih.gov/27068633

Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (from the DAF-ESUS registry).

José Manuel Rubio Campal, M Araceli García Torres, Pepa Sánchez Borque...

https://pubmed.ncbi.nlm.nih.gov/31780074

Real-world experience with implantable loop recorder monitoring to detect subclinical atrial fibrillation in patients with cryptogenic stroke: The value of p wave dispersion in predicting arrhythmia occurrence.

Daniel Marks, Rady Ho, Ryna Then...

https://pubmed.ncbi.nlm.nih.gov/33186666

Comparison of the Effect of Atrial Fibrillation Detection Algorithms in Patients With Cryptogenic Stroke Using Implantable Loop Recorders.

Ehud Chorin, Connor Peterson, Edward Kogan...

https://pubmed.ncbi.nlm.nih.gov/32600783