RecruitingNot ApplicableNCT06542770

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

Subtle Ultrasound Atrial Anomalies Predicts the Early Diagnosis of Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Patients With Cryptogenic Stroke. A Randomized Trial


Sponsor

Parc de Salut Mar

Enrollment

100 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether certain structural abnormalities in the upper chambers of the heart (the atria) — detected on standard cardiac imaging — can predict the later development of silent atrial fibrillation (AFib) in people who had a stroke or mini-stroke (TIA) with no identifiable cause. An implantable cardiac monitor (a small device placed under the skin to continuously record heart rhythm) is used to detect AFib that would otherwise go unnoticed. **You may be eligible if...** - You are 50–89 years old - You had an ischemic stroke or TIA between January 2022 and July 2023 - No cause for the stroke was found despite standard workup (no structural heart disease, no AFib detected on initial monitoring, no major artery problems in the neck) **You may NOT be eligible if...** - You have a history of hemorrhagic stroke (bleeding in the brain) - You already have a diagnosed history of atrial fibrillation or flutter - You have a permanent contraindication to an implantable cardiac monitor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEEarly implant of cardiac monitor

ICM implant 3-4 days after the stroke and prior to discharge. All devices (Abbott Confirm or Jot) were implanted subcutaneously under local anaesthesia in the left chest region and programmed with an specific algorithm for AF detection set at 30 seconds for detection. All patients were included in remote monitoring system (Merlin), which was programmed to send alerts in case of registering episodes qualifying for AF detection, and a monthly routine registration. All ICM recordings were reviewed by a specialized cardiologist.


Locations(1)

Hospital del Mar

Barcelona, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06542770


Related Trials