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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-89
SponsorParc de Salut Mar

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023

Age between 50 and 89 years;

Absence of major structural heart disease by cardiac ultrasound (normal global and segmental left ventricle contraction, absence of valvular/rheumatic disease, absence of intracardiac shunts)

Absence of AF during 48h ECG-monitoring

Disqualifiers

Patients with a history of hemorrhagic stroke;

Presence with prior atrial fibrillation or atrial flutter;

Permanent contraindication or indication for OAC for other reasons;

Recent (<1 month) major surgery or cardiac events;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early implant of cardiac monitor

    Device

    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.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Atrial cardiomyopathy by echocardiogram interventionExperimental treatment 1 intervention
Group B: Atrial cardiomyopathy by echocardiogram standard practiceNo intervention 0 interventions
Group C: Non atrial cardiomyopathy by echocardiogram interventionExperimental treatment 1 intervention
Group D: Non atrial cardiomyopathy by echocardiogram standard practiceNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Detection atrial fibrilation at follow-up

defined by the presence of a confirmatory 12-leads ECG, or a registration lasting more than 30 seconds in, either the 72h-Holter-Monitoring, or in the ICM recording. In case of AF detection OAC was initiated immediately.

Time frame
Up to 2 years follow-up (ICM and standard care practice)

Secondary outcomes

1

LA indexed volume

LA indexed volume in ml/m2

Time frame
Before Day 3 since the Criptogenic Stroke
2

Maximum Systolic Global Longitudinal Strain (PALs)

Maximum Systolic Global Longitudinal Strain (PALs) in %

Time frame
Before Day 3 since the Criptogenic Stroke
3

Atrial Contraction Strain (PACs)

atrial contraction strain (PACs) in %

Time frame
Before Day 3 since the Criptogenic Stroke
4

Atrial Ejection Fraction

Atrial ejection fraction in %

Time frame
Before Day 3 since the Criptogenic Stroke

Other outcomes

Sponsors and contacts

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