The Norwegian Stroke in the Young Study II (NOR-SYSII)

NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and plaques and consequences of stroke are examined by standardized diagnostics.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke at a Young Age

Detailed Description

NOR-SYS II is as far as possible standardized concerning patients' history, ultrasound examination of pre-cerebral and femoral arteries, and standardized examinations performed by speech therapists, occupational therapists and physiotherapists.

The ultrasound-protocol for carotid and femoral arteries is the same as previously performed in the NOR-SYS study. The Methods have been published before.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with documented ischemic stroke at a young age (< 50 years) in Norway

Description

Inclusion Criteria:

• Documented acute, arterial ischemic stroke
• Speaks Norwegian fluently

Exclusion Criteria:

• Post-traumatic and procedure related stroke
• Sinus venous thrombosis, sepsis and endocarditis
• Serious co-morbidity, such as advanced cancer with "end-of-life stroke".
• Patients mentally retarded or with severe psychiatric disease who do not accept the diagnosis and who would need sedation to perform clinical diagnostics.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Established atherosclerosis	The ultrasound protocol of the NOR-SYS study will be applied for carotid and femoral arteries. In addition angiographies will be done for patients with suspicious arterial disease. The measurements will be done within hospital stay after the acute stroke.	Established atherosclerosis will serve as outcome measure for data collected during hospital stay and will be related to risk factors. The data will be presented one year after finishing the 5-years of inclusion of the whole study group.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New cardiovascular events	Patients With different causes of ischemic stroke have different prognosis that is worst for recurrent stroke and other cardiovascular events for patients with atherosclerosis.	One year after the stroke
Death	Death fro all causes with subgroups of cardiovascular death, cancer and other causes of death will be registered	One year after the stroke
Alive but not back to previous education or full-time job	Not back to work because of stroke related problems. Standardized questionnaires will be used to collect information about education and work before stroke and the situation after 3 months and one year. The frequency and reasons why patients did not come back to their education situation or their job they did before the stroke are collected. We expect that it is still possible within a year from stroke onset, to specify the sort of problem related to stroke or unrelated to stroke. This may get more unspecific, the longer the time gets from stroke onset to follow-up. NOR-SYS II will focus on a particular group of patients that seem to function well but that struggle with unvisible problems such as tiredness and reduced capacity / energy to work.	One year after the stroke

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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): March 1, 2016
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Risk factors; Consequences; Causes; Young ischemic stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2015 / 1769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Contribution to the SECRETO study Contribution to other young ischemic stroke trials, if actual
• IPD Sharing Time Frame: Data can be shared after the study is completed in 2022.
• IPD Sharing Access Criteria: Actual study protocols have to be approved by the Ethics Committee, and may after approval receive actual data from the NOR-SYS II study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL