Atrial Imaging and Cardiac Rhythm In Embolic Stroke

NCT ID: NCT05486221

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-17

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Cryptogenic Stroke Atrial Fibrillation Atrial Dilatation Stroke, Ischemic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Extensive cardiologic work-up

Intervention Type OTHER

Specific 3D and 2D echocardiography measuring left ventricule and left atrial dimensions as well as longitudinal strain. 30 day prolonged ECG monitoring.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Proyecto Ictus- Grupo Estudio Enfermedades CerebroVasculares de la Sociedad Española de Neurología

UNKNOWN

Sponsor Role collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Rigual Bobillo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Locations

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La Paz University Hospital

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ricardo Rigual Bobillo, MD

Role: CONTACT

917277444 ext. +34

Elena de Celis Ruiz, MD

Role: CONTACT

917277444 ext. +34

Facility Contacts

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Ricardo Rigual Bobillo, MD

Role: primary

917277444 ext. +34

Elena de Celis Ruiz, MD

Role: backup

917277444 ext. +34

Other Identifiers

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PI-4509

Identifier Type: -

Identifier Source: org_study_id

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