NOR-SYS: The Norwegian Stroke in the Young Study (NOR-SYS)

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Disease; Death; Peripheral Artery Disease; Carotid Artery Disease
• Intervention / Treatment: Behavioral: Lifestyle counseling

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 Type: Interventional
• Enrollment (Actual): 1062
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5053
    • Dep. of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lifestyle counseling; There are no different arms, NOR-SYS is an observational study	Behavioral: Lifestyle counseling; Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling; Other Names: NOR-SYS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Outcome measure is assessed every five years.	15 years for patients and partners and 20 years for offspring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease	Outcome measure is assessed every five years.	15 years for patients and partners and 20 years for offspring

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Ulrike Waje-Andreassen, MD, PhD, Haukeland UH

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): August 31, 2015
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (Estimated): May 14, 2012

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Families; Long-term follow-up; Young ischemic stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Carotid Artery Diseases; Cardiovascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 2010/74