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

• ClinicalTrials.gov Identifier: NCT02762396
• Recruitment Status: Unknown
• First Posted: May 5, 2016
• Last Update Posted: May 5, 2016
• Sponsor: Haukeland University Hospital
• Collaborator: Helsinki University Central Hospital
• Information provided by (Responsible Party): Haukeland University Hospital

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 600 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Official Title: The Norwegian Stroke in the Young Study II
• Study Start Date: March 2016
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: February 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Biospecimen Retention:   Samples With DNA

EDTA-blood and serum will be collected for future analysis

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 49 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Ulrike Waje-Andreassen, MD, PhD; +4755975045; uwan@helse-bergen.no

Contact: Annette Fromm, MD, PhD; +4755975045; Annette.Fromm@helse-bergen.no

Locations

Norway

Dep. of Neurology; Recruiting

Bergen, Norway, 5053

Sub-Investigator: Annette Fromm, MD

Principal Investigator: Ulrike Waje-Andreassen, MD, PhD

Sponsors and Collaborators

Haukeland University Hospital

Helsinki University Central Hospital

Investigators

• Principal Investigator: Ulrike Waje-Andreassen, MD, PhD; Haukeland University Hospital

More Information

Additional Information:

Publications:

Fromm A, Thomassen L, Naess H, Meijer R, Eide GE, Kråkenes 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.

• Responsible Party: Haukeland University Hospital
• ClinicalTrials.gov Identifier: NCT02762396
• Other Study ID Numbers: 2015 / 1769
• First Posted: May 5, 2016
• Last Update Posted: May 5, 2016
• Last Verified: May 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Contribution to the SECRETO study

Keywords provided by Haukeland University Hospital:

Young ischemic stroke; Risk factors; Causes; Consequences

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases