Atrial Imaging and Cardiac Rhythm In Embolic Stroke

NCT05486221 | Unknown

• 1 other identifier: PI-4509
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (1)

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

Interventions

Extensive cardiologic work-up OTHER

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

Cryptogenic stroke patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

La Paz University Hospital

Madrid, 28046, Spain

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo Rigual Bobillo, MD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Rigual Bobillo, MD

CONTACT

917277444; ricardojaime.rigual@salud.madrid.org

Elena de Celis Ruiz, MD

CONTACT

917277444; elena.decelis.ruiz@idipaz.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 3, 2022
• Study Start: December 17, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-05

Locations

ES (1)