The Norwegian Stroke in the Young Study II

Completed

• Conditions: Ischemic Stroke at a Young Age

• Registration Number: NCT02762396
• Lead Sponsor: Haukeland University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-05-02
• Study First Posted: 2016-05-05
• Primary Completion: 2021-02-28
• Study Completion: 2022-02-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Established atherosclerosis	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.	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.

Secondary Outcome Measures

Name	Time	Method
Alive but not back to previous education or full-time job	One year after the stroke	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.
New cardiovascular events	One year after the stroke	Patients With different causes of ischemic stroke have different prognosis that is worst for recurrent stroke and other cardiovascular events for patients with atherosclerosis.
Death	One year after the stroke	Death fro all causes with subgroups of cardiovascular death, cancer and other causes of death will be registered

Trial Locations

Locations (1)

Dep. of Neurology; 🇳🇴 Bergen, Norway