NCT01597453: NOR-SYS

NOR-SYS: The Norwegian Stroke in the Young Study

Active, enrolled NA Last updated 1 April 2025

What this trial tests

NA trial testing Lifestyle counseling in Death in 1,062 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2010

Primary endpoint
31 August 2015

31 December 2030

Quick facts

Lead sponsor	Haukeland University Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	1,062
Start date	1 September 2010
Primary completion	31 August 2015
Estimated completion	31 December 2030
Sites	1 location across Norway

Drugs / interventions tested

• Lifestyle counseling

Conditions studied

• Death — all drugs for Death →
• Carotid Artery Disease — all drugs for Carotid Artery Disease →
• Cardiovascular Disease — all drugs for Cardiovascular Disease →
• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →

Sponsor

Haukeland University Hospital

Who can join

Adults 15 to 60, any sex, with Death or Carotid Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Norwegian Stroke in the Young Study (NOR-SYS): rationale and design.
   Fromm A, Thomassen L, Naess H, Meijer R, et al · · 2013 · cited 21× · PMID 23865483 · DOI 10.1186/1471-2377-13-89
2. Early vascular aging in young and middle-aged ischemic stroke patients: the Norwegian Stroke in the Young Study.
   Saeed S, Waje-Andreassen U, Fromm A, Øygarden H, et al · · 2014 · cited 20× · PMID 25405619 · DOI 10.1371/journal.pone.0112814
3. 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.
   Fromm A, Haaland ØA, Naess H, Thomassen L, et al · · 2014 · cited 13× · PMID 24669965 · DOI 10.1186/1756-0500-7-176
4. Prevalence of atherosclerosis and association with 5-year outcome: The Norwegian Stroke in the Young Study.
   Nawaz B, Fromm A, Øygarden H, Eide GE, et al · · 2021 · cited 8× · PMID 35342817 · DOI 10.1177/23969873211059472
5. Young ischaemic stroke incidence and demographic characteristics - The Norwegian stroke in the young study - A three-generation research program.
   Nawaz B, Eide GE, Fromm A, Øygarden H, et al · · 2019 · cited 8× · PMID 31903433 · DOI 10.1177/2396987319863601
6. Can the cardiovascular family history reported by our patients be trusted? The Norwegian Stroke in the Young Study.
   Øygarden H, Fromm A, Sand KM, Eide GE, et al · · 2016 · cited 7× · PMID 26293608 · DOI 10.1111/ene.12824
7. 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).
   Øygarden H, Fromm A, Sand KM, Kvistad CE, et al · · 2016 · cited 6× · PMID 27504830 · DOI 10.1371/journal.pone.0159811
8. Stroke patients' knowledge about cardiovascular family history - the Norwegian Stroke in the Young Study (NOR-SYS).
   Øygarden H, Fromm A, Sand KM, Eide GE, et al · · 2015 · cited 5× · PMID 25884546 · DOI 10.1186/s12883-015-0276-6