NOR-SYS: The Norwegian Stroke in the Young Study

NCT ID: NCT01597453

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1062 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-01
• Study Completion Date: 2030-12-31

Brief 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.

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

Conditions

Death; Carotid Artery Disease; Cardiovascular Disease; Peripheral Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lifestyle counseling

There are no different arms, NOR-SYS is an observational study

Group Type: OTHER

Lifestyle counseling

Intervention Type: BEHAVIORAL

Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling

Interventions

Lifestyle counseling

Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling

Intervention Type: BEHAVIORAL

Other Intervention Names

NOR-SYS

Eligibility Criteria

Inclusion Criteria

• Documented ischemic stroke at age from 15 up to 60 years

Exclusion Criteria

• Stroke as end-of-life event among patients with cancer or other life-threatening disease
• Stroke caused by trauma

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrike Waje-Andreassen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland UH

Locations

Dep. of Neurology

Bergen, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 40079310 (View on PubMed)

Oftedal 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.

Reference Type: DERIVED

PMID: 29334265 (View on PubMed)

Oygarden 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.

Reference Type: DERIVED

PMID: 27504830 (View on PubMed)

Oygarden 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.

Reference Type: DERIVED

PMID: 25884546 (View on PubMed)

Saeed 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.

Reference Type: DERIVED

PMID: 25405619 (View on PubMed)

Fromm 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.

Reference Type: DERIVED

PMID: 24669965 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23865483 (View on PubMed)

Other Identifiers

2010/74

Identifier Type: -

Identifier Source: org_study_id