Stroke, AcuteNCT05786170
ERILs Und SNILs Unter SOC
A study testing diffusion-weighted magnetic resonance imaging in people with Stroke, Acute, run by Medical University of Vienna.
Trial summary
1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment? 2. How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment? 3. How many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days? 4. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- diffusion-weighted magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to 5 Jul 2021
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LAA stroke or TIA
- ERILs or SNILs detected in initialDW-MRI
- signed informed consent
Who cannot join
- planned surgical intervention
- iv Thrombolysis
- atrial fibrillation
- contra indications against DW-MRI
About this study
Official title: Early Recurrent Ischemic Lesions (ERILs) and Silent Neurologic Ischemic Lesions (SNILs) in Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) - a Pilot- Observational Study Under Standard of Care (SOC)
- How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?
- How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment?
- How many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days?
- Are there relevant risk faktors for the occurence of ERILs and SNILs (eg Diabetes or Biomarkers)?
Read the detailed description
In this trial, patients will be observed if they develop early recurrent ischemic lesions (= ERILs) or silent neurologic ischemic lesions (= SNILs) after acute stroke or transitoric ischemic attack (TIA) based on atherothrombosis (LAA-stroke) on standard therapy during 30 days (day 7 and day 30 after acute event) via DW-MRI (diffusion-weighted magnetic resonance imaging).
We want to investigate if diffusion-weighted imaging of silent brain infarcts occuring during standard therapy is a suitable surrogate outcome measure for interventional studies
- Conditions
- Stroke, Acute
- Being tested
- diffusion-weighted magnetic resonance imaging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion-weighted magnetic resonance imagingDiagnostic test
diffusion-weighted magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| magnetic resonance imaging | Experimental | DW-MRI after ischemic stroke Receives: Diagnostic Test: diffusion-weighted magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?
DW-MRI to detect lesions
Measured: 7 days after acute stroke
Secondary outcomes (1)
2. How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment and how many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days?
DW-MRI to detect lesions
Measured: 30 days after acute stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study startSep 2019 (estimated)
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Why it stopped: lack of research funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Principal investigator, Christa Firbas MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786170
- Sponsor's protocol ID
- ERILs und SNILs unter SOC
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 27 Mar 2023
- 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 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recurrent Ischemic Lesions (ERILs) and Silent Neurologic Ischemic Lesions (SNILs) in Diffusion-weighted Magnetic Resonance Imaging (DW-MRI) - a Pilot- Observational Study Under Standard of Care (SOC)
- ClinicalTrials.gov ID
- NCT05786170
- Acronym / sponsor ID
- ERILs und SNILs unter SOC
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of research funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- Sep 2019 (estimated)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 27 Mar 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.
- How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?
- How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment?
- How many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days?
- Are there relevant risk faktors for the occurence of ERILs and SNILs (eg Diabetes or Biomarkers)?
Detailed description
In this trial, patients will be observed if they develop early recurrent ischemic lesions (= ERILs) or silent neurologic ischemic lesions (= SNILs) after acute stroke or transitoric ischemic attack (TIA) based on atherothrombosis (LAA-stroke) on standard therapy during 30 days (day 7 and day 30 after acute event) via DW-MRI (diffusion-weighted magnetic resonance imaging).
We want to investigate if diffusion-weighted imaging of silent brain infarcts occuring during standard therapy is a suitable surrogate outcome measure for interventional studies
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| magnetic resonance imaging | Experimental | Diagnostic Test: diffusion-weighted magnetic resonance imagingDW-MRI after ischemic stroke |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- LAA stroke or TIA
- ERILs or SNILs detected in initialDW-MRI
- signed informed consent
Key exclusion criteria (4 listed)
- planned surgical intervention
- iv Thrombolysis
- atrial fibrillation
- contra indications against DW-MRI
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 |
|---|---|---|
| diffusion-weighted magnetic resonance imagingdiffusion-weighted magnetic resonance imaging | Diagnostic test | magnetic resonance imaging |
Primary outcome
1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment?
Time frame: 7 days after acute stroke
DW-MRI to detect lesions
1 secondary outcome
2. How many SNILs occur between 7 and 30 days after acute ischemic event on standard treatment and how many of during acute event diagnosed lesions (ERILs) are (still) detectable after 30 days?
Time frame: 30 days after acute stroke
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion-weighted magnetic resonance imaging in people with Stroke, Acute, run by Medical University of Vienna.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
1. How many ERILs occur in caucasian patients with LAA stroke during 7 days on standard treatment? (time frame: 7 days after acute stroke). 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 27 Mar 2023.