Atrial Imaging and Cardiac Rhythm In Embolic Stroke

• Conditions: Stroke, Ischemic; Atrial Fibrillation; Cryptogenic Stroke; Atrial Dilatation
• Interventions: Other: Extensive cardiologic work-up

• Registration Number: NCT05486221
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

The ARIES study is an observational study in which patients with a recent acute ischemic stroke of cryptogenic aetiology are consecutively enrolled in order to perform a extensive cardiologic work-up. The main objective is to study parameters that could predict arrythmias on prolonged monitoring and also echocardiographic parameters of left atrial disfunction that could predict the presence of a hidden atrial fibrilation and recurrent ischemic events in patients with cryptogenic stroke.

Detailed Description

Cerebrovascular diseases are the second most frequent cause of death in the general population, representing a 10% of global death. In order to prevent recurrent strokes, it is crucial to identify the underlying cause to administrate the best treatment in secondary prevention. Cryptogenic strokes are those in which the etiology remains unknown despite performing an extensive work-up; they represent between 20-62% of strokes. Occult atrial fibrilation is thought underlie up to 40% of cryptogenic strokes; it has also reciently been postulated that other left atrial arrythmias (parafibrilatory status) and left atrial markers of disfunction could represent a cardiac source of emboli.

Tha hypothesis of the ARIES study is that an extensive cardiologic work-up (advanced echocardiography measuring strain /stain rate and 3D echo and a 30 day continuos ECG monitoring) would detect atrial disfunction, parafibrilatory status and atrial fibrilation in patients with cryptogenic stroke, and that patients with these findings could have more stroke recurrences. This study is designed as a prospective observational unicentric study that includes patients with cryptogenic stroke in a consecutive matter in La Paz University Hospital.

Study Timeline

• Study Start: 2020-12-17
• Status Verified: 2022-05
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-03
• Last Update Posted: 2022-08-03
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients addmitted to the Neurology service at La Paz University Hospital with a recent diagnosis of cryptogenic stroke considered non-lacunar and where no other reasonable diagnosis is suspected.
• Signed informed consent.

Exclusion Criteria

• Presence of large vessel atheromatosis with >50% estenosis, or <50% but with two or more vascular risk factors (age > 50 years old, hipertension, diabetes mellitus, dyslipidemia, smoker).
• Patients with a un favorable clinical situation or dependance who will not benefit from the study or those that could not fullfill study visits and procedures.
• Patients in which an embolic arrythmia has already been demonstrated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cryptogenic stroke patients	Extensive cardiologic work-up	Patients with an acute ischemic stroke of cryptogenic origin with a previous negative work-up that includes: blood analysis, brain CT / MRI, angio-TC / angio-MRI, brain vessel ultrasound, ECG, 24h ECG-holter, echocardiography).

Primary Outcome Measures

Name	Time	Method
Analyze frequency of parafibrilatory status in cryptogenic stroke patients	30 days	Analyze the frequency of parafibrilatory status defined as \> 3000 atrial ectopic beats per day or more or \>2 "micro-AF" episodes per day (fibrillatory burst \<30 seconds without a monomorphic P wave ) on 30 day ECG monitoring
Analyze frequency of ecocardiographic parameters of atrial disfunction	During hospitalization	Dimensions and function of left atrium, telesystolic volume, left auricular ejection fraction, atrial longitudinal strain in 3 phases (reservoir, conduict, contractile)
Frequency of detection of atrial fibrilation	60 days	Frequency of detection of atrial fibrilation lasting for more than 30 seconds on two 30 day ECG monitoring.
Correlation of parafibrilatory state and echocardiographic parameters of atrial disfunction with the probability of stroke recurrence.	At 3 months and 1 year.	Correlation of parafibrilatory state and echocardiographic parameters of atrial disfunction with the probability of stroke recurrence in patients without documented atrial fibrilation.
Correlation of parafibrilatory state and echocardiographic parameters of atrial disfunction with the probability of detection of atrial fibrilation.	30 days	Correlation of parafibrilatory state and echocardiographic parameters of atrial disfunction with the probability of detection of atrial fibrilation of more than 30 seconds of duration in 30-day ECG monitoring.

Trial Locations

Locations (1)

La Paz University Hospital; 🇪🇸 Madrid, Spain