ARIES: Atrial Imaging and Cardiac Rhythm In Embolic Stroke

Sponsor
Instituto de Investigación Hospital Universitario La Paz (Other)
Overall Status
Recruiting
CT.gov ID
NCT05486221
Collaborator
Hospital Universitario La Paz (Other), Proyecto Ictus- Grupo Estudio Enfermedades CerebroVasculares de la Sociedad Española de Neurología (Other)
150
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24.4
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Other
Time Perspective:
Prospective
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.
Actual Study Start Date :
Dec 17, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Analyze frequency of parafibrilatory status in cryptogenic stroke patients [30 days]

    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

  2. Analyze frequency of ecocardiographic parameters of atrial disfunction [During hospitalization]

    Dimensions and function of left atrium, telesystolic volume, left auricular ejection fraction, atrial longitudinal strain in 3 phases (reservoir, conduict, contractile)

  3. Frequency of detection of atrial fibrilation [60 days]

    Frequency of detection of atrial fibrilation lasting for more than 30 seconds on two 30 day ECG monitoring.

  4. Correlation of parafibrilatory state and echocardiographic parameters of atrial disfunction with the probability of detection of atrial fibrilation. [30 days]

    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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 La Paz University Hospital Madrid Spain 28046

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Ricardo Rigual Bobillo, MD, Hospital Universitario La Paz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT05486221
Other Study ID Numbers:
  • PI-4509
First Posted:
Aug 3, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022