Stroke, AcuteNCT05277129
The Immune Response to Stroke
An observational study of Stroke, Acute and Dementia, run by University of Oslo at 1 site in Norway.
Trial summary
Some patients develop cognitive decline after a stroke, but we don't always understand the mechanisms. It has been proposed that a proportion of the patients develop an autoimmune immune response, and that this could potentially explain the cognitive decline in some of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Dementia
- What is being tested?
- Analysis of post-stroke immune responses
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 24 Jun 2021to 6 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients suffering from acute cerebral infarction
Who may be able to join
- Stroke < 72 h
- Age > 18 years
Who cannot join
- Brain hemorrhage verified by CT or MRI scan
- Previous or present immunological disease or other serious comorbidity
- Ongoing immune respons after infection or vaccination < 1 month
- Cognitive without ability to understand and/or give an informed consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital
Lørenskog
Andreas Lossius, MD, PhD
About this study
Some patients develop cognitive decline after a stroke, but we don't always understand the mechanisms. It has been proposed that a proportion of the patients develop an autoimmune immune response, and that this could potentially explain the cognitive decline in some of the patients. The current study aims to investigate this hypothesis in a subgroup of patients with stroke.
- Conditions
- Stroke, Acute, Dementia
- Being tested
- Analysis of post-stroke immune responses
- Medical subject headings
- Stroke, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of post-stroke immune responsesOther
Analysis of immune responses in peripheral blood
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Not described Receives: Other: Analysis of post-stroke immune responses |
What is being measured
The primary outcome is the main question the study is designed to answer.
The B cell and T cell response in peripheral blood
Measured: 1 day (subject inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start24 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion6 Jun 2029 (estimated)
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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Lossius, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277129
- Sponsor's protocol ID
- 2019/1252
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immune Response to Stroke
- ClinicalTrials.gov ID
- NCT05277129
- Acronym / sponsor ID
- 2019/1252
- Conditions
- Stroke, Acute, Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 6 Jun 2029 (estimated)
- First posted
- 14 Mar 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.
Some patients develop cognitive decline after a stroke, but we don't always understand the mechanisms. It has been proposed that a proportion of the patients develop an autoimmune immune response, and that this could potentially explain the cognitive decline in some of the patients. The current study aims to investigate this hypothesis in a subgroup of patients with stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: Analysis of post-stroke immune responses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from acute cerebral infarction
Key inclusion criteria (2 listed)
- Stroke < 72 h
- Age > 18 years
Key exclusion criteria (4 listed)
- Brain hemorrhage verified by CT or MRI scan
- Previous or present immunological disease or other serious comorbidity
- Ongoing immune respons after infection or vaccination < 1 month
- Cognitive without ability to understand and/or give an informed consent to participate in the study
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 |
|---|---|---|
| Analysis of post-stroke immune responsesAnalysis of immune responses in peripheral blood | Other | Stroke patients |
Primary outcome
The B cell and T cell response in peripheral blood
Time frame: 1 day (subject inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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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.
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 Stroke, Acute and Dementia, run by University of Oslo at 1 site in Norway.
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 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: looking for participants now, as of the sponsor's last update on 14 Mar 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andreas Lossius, MD, PhD (+47 930 68 515, postmottak@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The B cell and T cell response in peripheral blood (time frame: 1 day (subject inclusion)). 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 14 Mar 2022.