DeathNOR-SYSNCT01597453
NOR-SYS: The Norwegian Stroke in the Young Study
A study testing Lifestyle counseling in people with Death and Carotid Artery Disease, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
NOR-SYS is a clinical research program about young ischemic stroke patients from 15 to 60 years. Patients, partners and the couple´s adult children who are at least 18 years old, are all invited to ultrasound examinations due to a standardized protocol. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Death, Carotid Artery Disease, Cardiovascular Disease
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,062 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2010to 31 Dec 2030
- Phase
- Interventional
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Documented ischemic stroke at age from 15 up to 60 years
Who cannot join
- Stroke as end-of-life event among patients with cancer or other life-threatening disease
- Stroke caused by trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors
NOR-SYS is a clinical research program about young ischemic stroke patients from 15 to 60 years. Patients, partners and the couple´s adult children who are at least 18 years old, are all invited to ultrasound examinations due to a standardized protocol.
Parents of patients and partners are invited to return their answers of standardized questionnaires about clinical ischemic events such as stroke, angina or myocardial infarction or peripheral artery disease.
Read more
Study inclusion time of patients and their families is 5 years. A biobank is build from samples from patients, partners and adult children. Clinical follow-ups for patients and partners are planned after 5, 10 and 15 years. Clinical follow-ups for adult children are planned after 10 and 20 years.
Hypotheses:
What do patients know about their parents clinical ischemic events? How much established pathology in arteries do we find by a standardized ultrasound protocol at the time of ischemic stroke at a young age? Differences concerning risk factors and ultrasound findings between patients and partners? Differences between children from families with several ischemic events among parents and grandparents vs. children from families without ischemic events? Biochemical markers related to ultrasound findings and artery disease.
Read the detailed description
Equal examinations for patients, partners and adult children are:
- Standardized questionnaires
- Extracranial duplexsonography
- Duplexsonography of the abdominal aorta
- Duplexsonography of femoral arteries
- Duplexsonography of epicardial, intrabdominal and subcutaneous fat
- Peripheral ultrasound, Ankle-arm index
- ECG
- Blood pressure measurement
- BMI and Waist-hip ratio
- Blood samples
- Being tested
- Lifestyle counseling
- Keywords
- Young ischemic stroke, Families, Long-term follow-up
- Medical subject headings
- Death, Carotid Artery Diseases, Cardiovascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
Also called NOR-SYS
Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Other | There are no different arms, NOR-SYS is an observational study Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Outcome measure is assessed every five years.
Measured: 15 years for patients and partners and 20 years for offspring
Secondary outcomes (1)
Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease
Outcome measure is assessed every five years.
Measured: 15 years for patients and partners and 20 years for offspring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study start1 Sep 2010
- Primary completion31 Aug 2015
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DeathStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Inclusion was completed in 2015, and the 5-year follow-up phase was completed in july 2021. The planned 10-year follow-up has not been possible due to the covid pandemia. A final 15 year follow-up was originally planned, and would start in 2025.
- Masking
- None (open label)
- Enrolment
- 1,062 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrike Waje-Andreassen, MD, PhD, Principal investigator, Haukeland UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597453
- Sponsor's protocol ID
- 2010/74
- Acronym
- NOR-SYS
- Status last verified
- Mar 2025
- First submitted
- 2 May 2012
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Jibril KA, Kuiper KJ, Nawaz B, Naess H, Fromm A, Oygarden H, Sand KM, Meijer R, Mohamed Ali A, Larsen TH, Bleie O, Skaar E, Waje-Andreassen U, Saeed S. Burden of Coronary Artery Disease as a Predictor of New Vascular Events and Mortality in Patients With Ischemic Stroke: Insights From the Norwegian Stroke in the Young Study. J Am Heart Assoc. 2025 Mar 18;14(6):e038899. doi: 10.1161/JAHA.124.038899. Epub 2025 Mar 13.
PubMed 40079310Oftedal A, Gerdts E, Waje-Andreassen U, Fromm A, Naess H, Linde A, Saeed S. Prevalence and covariates of uncontrolled hypertension in ischemic stroke survivors: the Norwegian stroke in the young study. Blood Press. 2018 Jun;27(3):173-180. doi: 10.1080/08037051.2018.1425827. Epub 2018 Jan 15.
PubMed 29334265Oygarden H, Fromm A, Sand KM, Kvistad CE, Eide GE, Thomassen L, Naess H, Waje-Andreassen U. A Family History of Stroke Is Associated with Increased Intima-Media Thickness in Young Ischemic Stroke - The Norwegian Stroke in the Young Study (NOR-SYS). PLoS One. 2016 Aug 9;11(8):e0159811. doi: 10.1371/journal.pone.0159811. eCollection 2016.
PubMed 27504830Oygarden H, Fromm A, Sand KM, Eide GE, Thomassen L, Naess H, Waje-Andreassen U. Stroke patients' knowledge about cardiovascular family history - the Norwegian Stroke in the Young Study (NOR-SYS). BMC Neurol. 2015 Mar 12;15:30. doi: 10.1186/s12883-015-0276-6.
PubMed 25884546Saeed S, Waje-Andreassen U, Fromm A, Oygarden H, Kokorina MV, Naess H, Gerdts E. Early vascular aging in young and middle-aged ischemic stroke patients: the Norwegian Stroke in the Young Study. PLoS One. 2014 Nov 18;9(11):e112814. doi: 10.1371/journal.pone.0112814. eCollection 2014.
PubMed 25405619Fromm A, Haaland OA, Naess H, Thomassen L, Waje-Andreassen U. Risk factors and their impact on carotid intima-media thickness in young and middle-aged ischemic stroke patients and controls: the Norwegian Stroke in the Young Study. BMC Res Notes. 2014 Mar 26;7:176. doi: 10.1186/1756-0500-7-176.
PubMed 24669965Fromm 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors
- ClinicalTrials.gov ID
- NCT01597453
- Acronym / sponsor ID
- NOR-SYS / 2010/74
- Keywords
- Young ischemic stroke, Families, Long-term follow-up
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,062 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 May 2012 (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 is a clinical research program about young ischemic stroke patients from 15 to 60 years. Patients, partners and the couple´s adult children who are at least 18 years old, are all invited to ultrasound examinations due to a standardized protocol.
Parents of patients and partners are invited to return their answers of standardized questionnaires about clinical ischemic events such as stroke, angina or myocardial infarction or peripheral artery disease.
Study inclusion time of patients and their families is 5 years. A biobank is build from samples from patients, partners and adult children. Clinical follow-ups for patients and partners are planned after 5, 10 and 15 years. Clinical follow-ups for adult children are planned after 10 and 20 years.
Hypotheses:
What do patients know about their parents clinical ischemic events? How much established pathology in arteries do we find by a standardized ultrasound protocol at the time of ischemic stroke at a young age? Differences concerning risk factors and ultrasound findings between patients and partners? Differences between children from families with several ischemic events among parents and grandparents vs. children from families without ischemic events? Biochemical markers related to ultrasound findings and artery disease.
Detailed description
Equal examinations for patients, partners and adult children are:
- Standardized questionnaires
- Extracranial duplexsonography
- Duplexsonography of the abdominal aorta
- Duplexsonography of femoral arteries
- Duplexsonography of epicardial, intrabdominal and subcutaneous fat
- Peripheral ultrasound, Ankle-arm index
- ECG
- Blood pressure measurement
- BMI and Waist-hip ratio
- Blood samples
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Inclusion was completed in 2015, and the 5-year follow-up phase was completed in july 2021. The planned 10-year follow-up has not been possible due to the covid pandemia. A final 15 year follow-up was originally planned, and would start in 2025.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Other | Behavioral: Lifestyle counselingThere are no different arms, NOR-SYS is an observational study |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Documented ischemic stroke at age from 15 up to 60 years
Key exclusion criteria (2 listed)
- Stroke as end-of-life event among patients with cancer or other life-threatening disease
- Stroke caused by trauma
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 |
|---|---|---|
| Lifestyle counselingAlso: NOR-SYSUltrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling | Behavioural | Lifestyle counseling |
Primary outcome
All cause mortality
Time frame: 15 years for patients and partners and 20 years for offspring
Outcome measure is assessed every five years.
1 secondary outcome
Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease
Time frame: 15 years for patients and partners and 20 years for offspring
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 1 Apr 2025.
- Derived from this study: PubMed 40079310Jibril KA, Kuiper KJ, Nawaz B, Naess H, Fromm A, Oygarden H, Sand KM, Meijer R, Mohamed Ali A, Larsen TH, Bleie O, Skaar E, Waje-Andreassen U, Saeed S. Burden of Coronary Artery Disease as a Predictor of New Vascular Events and Mortality in Patients With Ischemic Stroke: Insights From the Norwegian Stroke in the Young Study. J Am Heart Assoc. 2025 Mar 18;14(6):e038899. doi: 10.1161/JAHA.124.038899. Epub 2025 Mar 13.
- Derived from this study: PubMed 29334265Oftedal A, Gerdts E, Waje-Andreassen U, Fromm A, Naess H, Linde A, Saeed S. Prevalence and covariates of uncontrolled hypertension in ischemic stroke survivors: the Norwegian stroke in the young study. Blood Press. 2018 Jun;27(3):173-180. doi: 10.1080/08037051.2018.1425827. Epub 2018 Jan 15.
- Derived from this study: PubMed 27504830Oygarden H, Fromm A, Sand KM, Kvistad CE, Eide GE, Thomassen L, Naess H, Waje-Andreassen U. A Family History of Stroke Is Associated with Increased Intima-Media Thickness in Young Ischemic Stroke - The Norwegian Stroke in the Young Study (NOR-SYS). PLoS One. 2016 Aug 9;11(8):e0159811. doi: 10.1371/journal.pone.0159811. eCollection 2016.
- Derived from this study: PubMed 25884546Oygarden H, Fromm A, Sand KM, Eide GE, Thomassen L, Naess H, Waje-Andreassen U. Stroke patients' knowledge about cardiovascular family history - the Norwegian Stroke in the Young Study (NOR-SYS). BMC Neurol. 2015 Mar 12;15:30. doi: 10.1186/s12883-015-0276-6.
- Derived from this study: PubMed 25405619Saeed S, Waje-Andreassen U, Fromm A, Oygarden H, Kokorina MV, Naess H, Gerdts E. Early vascular aging in young and middle-aged ischemic stroke patients: the Norwegian Stroke in the Young Study. PLoS One. 2014 Nov 18;9(11):e112814. doi: 10.1371/journal.pone.0112814. eCollection 2014.
- Derived from this study: PubMed 24669965Fromm A, Haaland OA, Naess H, Thomassen L, Waje-Andreassen U. Risk factors and their impact on carotid intima-media thickness in young and middle-aged ischemic stroke patients and controls: the Norwegian Stroke in the Young Study. BMC Res Notes. 2014 Mar 26;7:176. doi: 10.1186/1756-0500-7-176.
- Derived from this study: 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.
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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.
Ulrike Waje-Andreassen, MD, PhD principal investigator
Haukeland UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Death and Carotid Artery Disease, 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. 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?
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?
All cause mortality (time frame: 15 years for patients and partners and 20 years for offspring). 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 NCT01597453, which also lists 7 linked publications.
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 1 Apr 2025.