Atrial Imaging and Cardiac Rhythm In Embolic Stroke (ARIES)

Atrial Imaging and Cardiac Rhythm In Embolic Stroke. Atrial Fibrilation, Parafibrillatory Electrocardiographic Patterns and Advanced Echocardiography for Left Atrial Evaluation in Cryptogenic Stroke.

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Stroke, Ischemic; Cryptogenic Stroke; Atrial Dilatation
• Intervention / Treatment: Other: Extensive cardiologic work-up

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • La Paz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients older than 50 years old addmitted to the neurology ward in La Paz University Hospital with a recent diagnosis of cryptogenic ischemic stroke.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cryptogenic stroke patients; 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).	Other: Extensive cardiologic work-up; Specific 3D and 2D echocardiography measuring left ventricule and left atrial dimensions as well as longitudinal strain. 30 day prolonged ECG monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyze frequency of parafibrilatory status in cryptogenic stroke patients	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	30 days
Analyze frequency of ecocardiographic parameters of atrial disfunction	Dimensions and function of left atrium, telesystolic volume, left auricular ejection fraction, atrial longitudinal strain in 3 phases (reservoir, conduict, contractile)	During hospitalization
Frequency of detection of atrial fibrilation	Frequency of detection of atrial fibrilation lasting for more than 30 seconds on two 30 day ECG monitoring.	60 days
Correlation of parafibrilatory state and echocardiographic parameters of atrial disfunction with the probability of detection of atrial fibrilation.	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.	30 days
Correlation of parafibrilatory state and echocardiographic parameters of atrial disfunction with the probability of stroke recurrence.	Correlation of parafibrilatory state and echocardiographic parameters of atrial disfunction with the probability of stroke recurrence in patients without documented atrial fibrilation.	At 3 months and 1 year.

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Hospital Universitario La Paz; Proyecto Ictus- Grupo Estudio Enfermedades CerebroVasculares de la Sociedad Española de Neurología

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation; Embolic Stroke
• Other Study ID Numbers: PI-4509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No