Ischemic Stroke at a Young AgeNOR-SYSIINCT02762396
The Norwegian Stroke in the Young Study II
An observational study of Ischemic Stroke at a Young Age, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and plaques and consequences of stroke are examined by standardized diagnostics. Read more about this study
- Who is it for?
- Ages 15 to 49 years
- Conditions the study is for
- Ischemic Stroke at a Young Age
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2016to 28 Feb 2022
- 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 15 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with documented ischemic stroke at a young age (< 50 years) in Norway
Who may be able to join
- Documented acute, arterial ischemic stroke
- Speaks Norwegian fluently
Who cannot join
- Post-traumatic and procedure related stroke
- Sinus venous thrombosis, sepsis and endocarditis
- Serious co-morbidity, such as advanced cancer with "end-of-life stroke".
- Patients mentally retarded or with severe psychiatric disease who do not accept the diagnosis and who would need sedation to perform clinical diagnostics.
Trial locations and contacts
1 site in 1 country.
About this study
NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and plaques and consequences of stroke are examined by standardized diagnostics.
Read the detailed description
NOR-SYS II is as far as possible standardized concerning patients' history, ultrasound examination of pre-cerebral and femoral arteries, and standardized examinations performed by speech therapists, occupational therapists and physiotherapists.
The ultrasound-protocol for carotid and femoral arteries is the same as previously performed in the NOR-SYS study. The Methods have been published before.
- Conditions
- Ischemic Stroke at a Young Age
- Keywords
- Young ischemic stroke, Risk factors, Causes, Consequences
What is being measured
The primary outcome is the main question the study is designed to answer.
Established atherosclerosis
The ultrasound protocol of the NOR-SYS study will be applied for carotid and femoral arteries. In addition angiographies will be done for patients with suspicious arterial disease. The measurements will be done within hospital stay after the acute stroke.
Measured: Established atherosclerosis will serve as outcome measure for data collected during hospital stay and will be related to risk factors. The data will be presented one year after finishing the 5-years of inclusion of the whole study group.
Secondary outcomes (3)
New cardiovascular events
Patients With different causes of ischemic stroke have different prognosis that is worst for recurrent stroke and other cardiovascular events for patients with atherosclerosis.
Measured: One year after the stroke
Death
Death fro all causes with subgroups of cardiovascular death, cancer and other causes of death will be registered
Measured: One year after the stroke
Alive but not back to previous education or full-time job
Not back to work because of stroke related problems. Standardized questionnaires will be used to collect information about education and work before stroke and the situation after 3 months and one year. The frequency and reasons why patients did not come back to their education situation or their job they did before the stroke are collected. We expect that it is still possible within a year from stroke onset, to specify the sort of problem related to stroke or unrelated to stroke. This may get more unspecific, the longer the time gets from stroke onset to follow-up. NOR-SYS II will focus on a particular group of patients that seem to function well but that struggle with unvisible problems such as tiredness and reduced capacity / energy to work.
Measured: One year after the stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start1 Mar 2016
- Primary completion28 Feb 2021
- Study completion28 Feb 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 Ischemic Stroke at a Young AgeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Sponsor
- Investigators
- Ulrike Waje-Andreassen, MD, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762396
- Sponsor's protocol ID
- 2015 / 1769
- Acronym
- NOR-SYSII
- Status last verified
- May 2023
- First submitted
- 1 Mar 2016
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Contribution to the SECRETO study Contribution to other young ischemic stroke trials, if actual
Publications
Fromm A, Thomassen L, Naess H, Meijer R, Eide GE, Krakenes J, Vedeler CA, Gerdts E, Larsen TH, Kuiper KK, Laxdal E, Russell D, Tatlisumak T, Waje-Andreassen U. The Norwegian Stroke in the Young Study (NOR-SYS): rationale and design. BMC Neurol. 2013 Jul 17;13:89. doi: 10.1186/1471-2377-13-89.
PubMed 23865483
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Norwegian Stroke in the Young Study II
- ClinicalTrials.gov ID
- NCT02762396
- Acronym / sponsor ID
- NOR-SYSII / 2015 / 1769
- Conditions
- Ischemic Stroke at a Young Age
- Keywords
- Young ischemic stroke, Risk factors, Causes, Consequences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 5 May 2016 (estimated)
- 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.
NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and plaques and consequences of stroke are examined by standardized diagnostics.
Detailed description
NOR-SYS II is as far as possible standardized concerning patients' history, ultrasound examination of pre-cerebral and femoral arteries, and standardized examinations performed by speech therapists, occupational therapists and physiotherapists.
The ultrasound-protocol for carotid and femoral arteries is the same as previously performed in the NOR-SYS study. The Methods have been published before.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 15 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with documented ischemic stroke at a young age (< 50 years) in Norway
Key inclusion criteria (2 listed)
- Documented acute, arterial ischemic stroke
- Speaks Norwegian fluently
Key exclusion criteria (4 listed)
- Post-traumatic and procedure related stroke
- Sinus venous thrombosis, sepsis and endocarditis
- Serious co-morbidity, such as advanced cancer with "end-of-life stroke".
- Patients mentally retarded or with severe psychiatric disease who do not accept the diagnosis and who would need sedation to perform clinical diagnostics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Established atherosclerosis
Time frame: Established atherosclerosis will serve as outcome measure for data collected during hospital stay and will be related to risk factors. The data will be presented one year after finishing the 5-years of inclusion of the whole study group.
The ultrasound protocol of the NOR-SYS study will be applied for carotid and femoral arteries. In addition angiographies will be done for patients with suspicious arterial disease. The measurements will be done within hospital stay after the acute stroke.
3 secondary outcomes
New cardiovascular events
Time frame: One year after the stroke
Death
Time frame: One year after the stroke
Alive but not back to previous education or full-time job
Time frame: One year after the 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 24 May 2023.
- Background: PubMed 23865483Fromm A, Thomassen L, Naess H, Meijer R, Eide GE, Krakenes J, Vedeler CA, Gerdts E, Larsen TH, Kuiper KK, Laxdal E, Russell D, Tatlisumak T, Waje-Andreassen U. The Norwegian Stroke in the Young Study (NOR-SYS): rationale and design. BMC Neurol. 2013 Jul 17;13:89. doi: 10.1186/1471-2377-13-89.
- Individual participant dataSharing planned: Yes. Contribution to the SECRETO study Contribution to other young ischemic stroke trials, if actual
Related trials for Ischemic Stroke at a Young Age
Active, not recruiting
A Pilot Study to Assess Optimal Prevention and Outcome Improvement in Young Ischemic Stroke
Ischemic Stroke at a Young Age, Secondary Prevention
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.
Ulrike Waje-Andreassen, MD, PhD principal investigator
Haukeland University Hospital
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 Ischemic Stroke at a Young Age, run by Haukeland 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 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: finished, as of the sponsor's last update on 24 May 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 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?
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?
Established atherosclerosis (time frame: Established atherosclerosis will serve as outcome measure for data collected during hospital stay and will be related to risk factors. The data will be presented one year after finishing the 5-years of inclusion of the whole study group.). 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 NCT02762396, 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 May 2023.