Cryptogenic StrokeARIESNCT05486221
Atrial Imaging and Cardiac Rhythm In Embolic Stroke
An observational study of Cryptogenic Stroke and Atrial Fibrillation, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cryptogenic Stroke, Atrial Fibrillation, Atrial Dilatation
- What is being tested?
- Extensive cardiologic work-up
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 17 Dec 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
La Paz University Hospital
Madrid, 28046
Ricardo Rigual Bobillo, MD, 917277444 ext. +34, ricardojaime.rigual@salud.madrid.org
Elena de Celis Ruiz, MD, 917277444 ext. +34, elena.decelis.ruiz@idipaz.es
About this study
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.
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.
Read the 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.
- Being tested
- Extensive cardiologic work-up
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensive cardiologic work-upOther
Specific 3D and 2D echocardiography measuring left ventricule and left atrial dimensions as well as longitudinal strain. 30 day prolonged ECG monitoring.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Extensive cardiologic work-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 3 months and 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start17 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptogenic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz, Proyecto Ictus- Grupo Estudio Enfermedades CerebroVasculares de la Sociedad Española de Neurología
- Responsible party
- Sponsor
- Investigators
- Ricardo Rigual Bobillo, MD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486221
- Sponsor's protocol ID
- PI-4509
- Acronym
- ARIES
- Status last verified
- May 2022
- First submitted
- 2 Aug 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05486221
- Acronym / sponsor ID
- ARIES / PI-4509
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz, Proyecto Ictus- Grupo Estudio Enfermedades CerebroVasculares de la Sociedad Española de Neurología
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryptogenic stroke patients | – | Other: Extensive cardiologic work-upPatients 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extensive cardiologic work-upSpecific 3D and 2D echocardiography measuring left ventricule and left atrial dimensions as well as longitudinal strain. 30 day prolonged ECG monitoring. | Other | Cryptogenic stroke patients |
Primary outcome
Analyze frequency of parafibrilatory status in cryptogenic stroke patients
Time frame: 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
Analyze frequency of ecocardiographic parameters of atrial disfunction
Time frame: During hospitalization
Dimensions 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 fibrilation
Time frame: 60 days
Frequency 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.
Time frame: 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.
Correlation of parafibrilatory state and echocardiographic parameters of atrial disfunction with the probability of stroke recurrence.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Rigual Bobillo, MD principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptogenic Stroke and Atrial Fibrillation, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Rigual Bobillo, MD (917277444 ext. +34, ricardojaime.rigual@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze frequency of parafibrilatory status in cryptogenic stroke patients (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.