Atrial Imaging and Cardiac Rhythm In Embolic Stroke

Atrial Fibrillation Clinical Trial

— ARIES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05486221
• Other study ID #: PI-4509
• Status: Recruiting
• Start date: December 17, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Ricardo Rigual Bobillo, MD
• Phone: 917277444
• Email: ricardojaime.rigual[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Dilatation
• Atrial Fibrillation
• Cryptogenic Stroke
• Embolic Stroke
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

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.

Locations

Country	Name	City	State
Spain	La Paz University Hospital	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Hospital Universitario La Paz, Proyecto Ictus- Grupo Estudio Enfermedades CerebroVasculares de la Sociedad Española de Neurología

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.