NOR-SYS: The Norwegian Stroke in the Young Study

NCT01597453 | Active Not Recruiting

• 1 other identifier: 2010/74
• Study Type: interventional
• Target: 1,062
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Young ischemic stroke; Families; Long-term follow-up

Outcome Measures

Primary Outcomes (1)

• All cause mortality

  Outcome measure is assessed every five years.

  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

  15 years for patients and partners and 20 years for offspring

Study Arms (1)

Lifestyle counseling

OTHER

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

Behavioral: Lifestyle counseling

Interventions

Lifestyle counseling BEHAVIORAL

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

Also known as: NOR-SYS

Lifestyle counseling

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Dep. of Neurology

Bergen, 5053, Norway

Location

Related Publications (7)

• 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.

  PMID: 40079310 DERIVED

• 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.

  PMID: 29334265 DERIVED

• 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.

  PMID: 27504830 DERIVED

• 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.

  PMID: 25884546 DERIVED

• 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.

  PMID: 25405619 DERIVED

• 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.

  PMID: 24669965 DERIVED

• 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.

  PMID: 23865483 DERIVED

MeSH Terms

Conditions

Death; Carotid Artery Diseases; Cardiovascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Officials

• Ulrike Waje-Andreassen, MD, PhD

  Haukeland UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 14, 2012
• Study Start: September 1, 2010
• Primary Completion: August 31, 2015
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

NO (1)