Acute Ischemic StrokeOSCARNCT06220981
The Oslo Acute Reperfusion Stroke Study (OSCAR)
An observational study of Acute Ischemic Stroke, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Prospective registry of clinical and radiological data in acute ischemic stroke patients after endovascular treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Endovascular treatment
- How many people
- 1,500 participants
- Where
- 1 siteNorway
- Study dates
- 10 Jan 2017to 31 Dec 2025
- How long will I take part?
- 1 Year
- 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
- Adult, Older adult
Study population: acute ischemic stroke patients with proximal cerebral artery occlusion admitted for endovascular treatment.
Who may be able to join
- Age 18 years or older
- Patients with ischemic stroke and cerebral arterial occlusion treated with endovascular revascularization.
- All stroke severities and vascular distributions are eligible.
- Informed written consent signed by the patient, verbal consent from the patient as witnessed by a non-participating health care person or consent by the signature of the patient's family must be provided before inclusion. Patients for whom no informed consent can be obtained will not be included in the study but will be treated according to standard guidelines.
Who cannot join
- Patient not eligible for the study or not available for follow-up assessments (e.g. non- resident).
Trial locations and contacts
1 site in 1 country.
Brian Enriquez contact
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Anne Hege Aamodt, MD PhD Prof, +47 23 07 00 00, anhaam@ous-hf.no
Brian Enriquez, MD, +47 23 07 00 00, brienr@ous-hf.no
About this study
Prospective registry of clinical and radiological data in acute ischemic stroke patients after endovascular treatment.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Endovascular treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatmentOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale Score
Modified Rankin Scale Score (mRS), min 0, max 6
Measured: 3 months
Secondary outcomes (6)
National Institute of Health Stroke Scale Score
National Institute of Health Stroke Scale Score (NIHSS, min 0, max 42)
Measured: discharge
Death due to any cause
Mortality
Measured: 3 months
Infarct volume
Infarct volume (ml)
Measured: 1 day
Incidence of symptomatic intracranial hemorrhage
Incidence of symptomatic intracranial hemorrhage (SICH)
Measured: 1 day
Volume of new areas of diffusion restriction
Volume of new areas of diffusion restriction
Measured: 1 day
serious adverse events
serious adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start10 Jan 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Hege Aamodt, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220981
- Sponsor's protocol ID
- 2015-17637
- Other IDs
- 2015
- Acronym
- OSCAR
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Enriquez BAB, Skattor TH, Laugesen NG, Truelsen T, Lund CG, Nome T, Beyer MK, Skjelland M, Aamodt AH. External validation of clinical risk prediction score for elderly treated with endovascular thrombectomy. J Neurol. 2024 Sep;271(9):5838-5845. doi: 10.1007/s00415-024-12535-6. Epub 2024 Jul 2.
PubMed 38954035
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oslo Acute Reperfusion Stroke Study (OSCAR)
- ClinicalTrials.gov ID
- NCT06220981
- Acronym / sponsor ID
- OSCAR / 2015-17637
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jan 2024 (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.
Prospective registry of clinical and radiological data in acute ischemic stroke patients after endovascular treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- acute ischemic stroke patients with proximal cerebral artery occlusion admitted for endovascular treatment.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Patients with ischemic stroke and cerebral arterial occlusion treated with endovascular revascularization.
- All stroke severities and vascular distributions are eligible.
- Informed written consent signed by the patient, verbal consent from the patient as witnessed by a non-participating health care person or consent by the signature of the patient's family must be provided before inclusion. Patients for whom no informed consent can be obtained will not be included in the study but will be treated according to standard guidelines.
Key exclusion criteria (1 listed)
- Patient not eligible for the study or not available for follow-up assessments (e.g. non- resident).
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 |
|---|---|---|
| Endovascular treatment | Other | – |
Primary outcome
Modified Rankin Scale Score
Time frame: 3 months
Modified Rankin Scale Score (mRS), min 0, max 6
6 secondary outcomes
National Institute of Health Stroke Scale Score
Time frame: discharge
Death due to any cause
Time frame: 3 months
Infarct volume
Time frame: 1 day
Incidence of symptomatic intracranial hemorrhage
Time frame: 1 day
Volume of new areas of diffusion restriction
Time frame: 1 day
serious adverse events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 38954035Enriquez BAB, Skattor TH, Laugesen NG, Truelsen T, Lund CG, Nome T, Beyer MK, Skjelland M, Aamodt AH. External validation of clinical risk prediction score for elderly treated with endovascular thrombectomy. J Neurol. 2024 Sep;271(9):5838-5845. doi: 10.1007/s00415-024-12535-6. Epub 2024 Jul 2.
- Individual participant dataSharing planned: Undecided
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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.
Brian Enriquez contact
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 Acute Ischemic Stroke, run by Oslo University Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 24 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Hege Aamodt (97417734, anne.hege.aamodt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale Score (time frame: 3 months). 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 NCT06220981, 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 24 Jan 2024.