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Completed

NCT Number: NCT02762396

The Norwegian Stroke in the Young Study II

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.

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Key information

Conditions

Ischemic Stroke at a Young Age

Age range

15 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Neurology

Bergen, 5053, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Established atherosclerosis

    Time frame: 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 outcomes

  1. New cardiovascular events

    Time frame: 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.

  2. Death

    Time frame: One year after the stroke

    Death fro all causes with subgroups of cardiovascular death, cancer and other causes of death will be registered

  3. Alive but not back to previous education or full-time job

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • Helsinki University Central Hospital

Registry information

Acronym: NOR-SYSII

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
May 5, 2016
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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