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Atrial Imaging and Cardiac Rhythm In Embolic Stroke

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05486221
Acronym
ARIES
Enrollment
150
Registered
2022-08-03
Start date
2020-12-17
Completion date
2022-12-31
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Dilatation, Atrial Fibrillation, Cryptogenic Stroke, Stroke, Ischemic

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.

Interventions

OTHERExtensive 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.

Sponsors

Hospital Universitario La Paz
CollaboratorOTHER
Proyecto Ictus- Grupo Estudio Enfermedades CerebroVasculares de la Sociedad Española de Neurología
CollaboratorUNKNOWN
Instituto de Investigación Hospital Universitario La Paz
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analyze frequency of parafibrilatory status in cryptogenic stroke patients30 daysAnalyze 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 disfunctionDuring hospitalizationDimensions 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 fibrilation60 daysFrequency 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 detection of atrial fibrilation.30 daysCorrelation 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.
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.

Countries

Spain

Contacts

Primary ContactRicardo Rigual Bobillo, MD
ricardojaime.rigual@salud.madrid.org917277444
Backup ContactElena de Celis Ruiz, MD
elena.decelis.ruiz@idipaz.es917277444

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026