Clinical trial NCT01597453: NOR-SYS: The Norwegian Stroke in the Young Study
Official title: NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Death
Carotid Artery Disease
Cardiovascular Disease
Peripheral Artery Disease
Keywords: Young ischemic stroke
Families
Long-term follow-up
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2012-05-14
Enrollment: 1062
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: All cause mortality
timeFrame: 15 years for patients and partners and 20 years for offspring
Secondary outcomes:
measure: Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease
timeFrame: 15 years for patients and partners and 20 years for offspring
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Dep. of Neurology
Study officials:
affiliation: Haukeland UH
name: Ulrike Waje-Andreassen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.