The Norwegian Stroke in the Young Study II

NCT02762396 | Completed

• 1 other identifier: 2015 / 1769
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke at a Young Age

Keywords

Young ischemic stroke; Risk factors; Causes; Consequences

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• New cardiovascular events

  One year after the stroke

• Death

  One year after the stroke

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

  One year after the stroke

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Documented acute, arterial ischemic stroke
• Speaks Norwegian fluently

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Helsinki University Central Hospital: collaborator

Study Sites (1)

Dep. of Neurology

Bergen, 5053, Norway

Location

Related Publications (1)

• 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.

  PMID: 23865483 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

EDTA-blood and serum will be collected for future analysis

Study Officials

• Ulrike Waje-Andreassen, MD, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: May 5, 2016
• Study Start: March 1, 2016
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2022
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be shared after the study is completed in 2022.
• 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

Locations

NO (1)