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Trial record 2 of 2 for:    NOR-SYS

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

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

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.

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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



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


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762396


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

Locations
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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
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Principal Investigator: Ulrike Waje-Andreassen, MD, PhD Haukeland University Hospital
Additional Information:

Publications:
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02762396    
Other Study ID Numbers: 2015 / 1769
First Posted: May 5, 2016    Key Record Dates
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:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases