Infarction, BrainNCT06018090
Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome
An observational study of Infarction, Brain and Embolism, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
Trial summary
This multicenter international prospective cohort study will include patients with AIS with a known or newly diagnosed anticoagulant-naïve AF. All centers will use the same transcranial Doppler machine for one-hour monitoring with bilateral 2-MHz probes within 24 hours of symptom onset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infarction, Brain, Embolism, Atrial Fibrillation
- What is being tested?
- The presence and rate of MES measured by TCD monitoring
- How many people
- 61 participants
- Where
- 1 sitePortugal
- Study dates
- 6 Jun 2019to 6 Oct 2022
- How long will I take part?
- 90 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter, or a new diagnosis of AF at the time of stroke, and able possibility to be monitored within 24 hours after symptom onset.
Who may be able to join
- acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter or a new diagnosis of AF at the stroke, and with a possibility to be monitored within 24 hours after symptom onset.
Who cannot join
- use of anticoagulants at stroke onset; prosthetic valves; inadequate temporal bone window; uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome - A Prospective Multicenter Study With Transcranial Doppler
This multicenter international prospective cohort study will include patients with AIS with a known or newly diagnosed anticoagulant-naïve AF. All centers will use the same transcranial Doppler machine for one-hour monitoring with bilateral 2-MHz probes within 24 hours of symptom onset. Recordings will be analyzed for MES by a blinded central reader. The primary aim is to determine the proportion of patients with MES and the association of MES with functional outcomes assessed by a modified Rankin scale (mRS) score at 90 days.
- Conditions
- Infarction, Brain, Embolism, Atrial Fibrillation
- Being tested
- The presence and rate of MES measured by TCD monitoring
- Keywords
- Infarction, Embolism, Atrial Fibrillation, Ultrasound, Transcranial Doppler
- Medical subject headings
- Brain Infarction, Embolism, Atrial Fibrillation, Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The presence and rate of MES measured by TCD monitoringOther
TCD monitoring within 24 hours from the last known well time. Bilateral M1 segments of middle cerebral artery were insonated at a single depth with 2-MHz transducers secured by a probe-holder.
| Study group | Role | What they receive |
|---|---|---|
| Acute Ischemic Stroke Patients with Atrial Fibrillation | Not described Receives: Other: The presence and rate of MES measured by TCD monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of MES
Measured: Within 24 hours of symptom onset
Poor functional outcome
Measured: 90-days after stroke
Secondary outcomes (1)
Ordinal Shift Analysis of mRS scale score
Measured: 90-days after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start6 Jun 2019
- Primary completion31 Aug 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infarction, BrainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Giessen, University of Padova, University of Ostrava, Clinical Hospital Centre Zagreb
- Responsible party
- Principal investigator, Pedro Castro, Centro Hospitalar De São João, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018090
- Sponsor's protocol ID
- 362/19
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Castro P, Ferreira J, Malojcic B, Bazadona D, Baracchini C, Pieroni A, Skoloudik D, Azevedo E, Kaps M. Detection of microemboli in patients with acute ischaemic stroke and atrial fibrillation suggests poor functional outcome. Eur Stroke J. 2024 Jun;9(2):409-417. doi: 10.1177/23969873231220508. Epub 2023 Dec 27.
PubMed 38149620
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microembolic Detection in Acute Ischemic Stroke Patients With Atrial Fibrillation and Outcome - A Prospective Multicenter Study With Transcranial Doppler
- ClinicalTrials.gov ID
- NCT06018090
- Acronym / sponsor ID
- 362/19
- Conditions
- Infarction, Brain, Embolism, Atrial Fibrillation
- Keywords
- Infarction, Embolism, Atrial Fibrillation, Ultrasound, Transcranial Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centro Hospitalar De São João, E.P.E.University, hospital or other
- Collaborators
- University of Giessen, University of Padova, University of Ostrava, Clinical Hospital Centre Zagreb
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 30 Aug 2023 (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.
This multicenter international prospective cohort study will include patients with AIS with a known or newly diagnosed anticoagulant-naïve AF. All centers will use the same transcranial Doppler machine for one-hour monitoring with bilateral 2-MHz probes within 24 hours of symptom onset. Recordings will be analyzed for MES by a blinded central reader. The primary aim is to determine the proportion of patients with MES and the association of MES with functional outcomes assessed by a modified Rankin scale (mRS) score at 90 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Ischemic Stroke Patients with Atrial Fibrillation | – | Other: The presence and rate of MES measured by TCD monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter, or a new diagnosis of AF at the time of stroke, and able possibility to be monitored within 24 hours after symptom onset.
Key inclusion criteria (1 listed)
- acute ischemic stroke admitted to the Stroke Unit, history of AF/flutter or a new diagnosis of AF at the stroke, and with a possibility to be monitored within 24 hours after symptom onset.
Key exclusion criteria (1 listed)
- use of anticoagulants at stroke onset; prosthetic valves; inadequate temporal bone window; uncooperative patients.
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 |
|---|---|---|
| The presence and rate of MES measured by TCD monitoringTCD monitoring within 24 hours from the last known well time. Bilateral M1 segments of middle cerebral artery were insonated at a single depth with 2-MHz transducers secured by a probe-holder. | Other | Acute Ischemic Stroke Patients with Atrial Fibrillation |
Primary outcome
Prevalence of MES
Time frame: Within 24 hours of symptom onset
Poor functional outcome
Time frame: 90-days after stroke
1 secondary outcome
Ordinal Shift Analysis of mRS scale score
Time frame: 90-days after stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Derived from this study: PubMed 38149620Castro P, Ferreira J, Malojcic B, Bazadona D, Baracchini C, Pieroni A, Skoloudik D, Azevedo E, Kaps M. Detection of microemboli in patients with acute ischaemic stroke and atrial fibrillation suggests poor functional outcome. Eur Stroke J. 2024 Jun;9(2):409-417. doi: 10.1177/23969873231220508. Epub 2023 Dec 27.
Related trials for Infarction, Brain
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infarction, Brain and Embolism, run by Centro Hospitalar De São João, E.P.E. at 1 site in Portugal.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Aug 2023. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of MES (time frame: Within 24 hours of symptom onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018090, which also lists 1 linked publication.
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 30 Aug 2023.