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Trial record 2 of 2 for:    NOR-SYS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02762396
Recruitment Status : Unknown
Verified May 2016 by Haukeland University Hospital.
Recruitment status was:  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

Tracking Information
First Submitted Date March 1, 2016
First Posted Date May 5, 2016
Last Update Posted Date May 5, 2016
Study Start Date March 2016
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2016)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 2, 2016)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Norwegian Stroke in the Young Study II
Official Title The Norwegian Stroke in the Young Study II
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 Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
EDTA-blood and serum will be collected for future analysis
Sampling Method Non-Probability Sample
Study Population Patients with documented ischemic stroke at a young age (< 50 years) in Norway
Condition Ischemic Stroke at a Young Age
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 2, 2016)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2022
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 49 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT02762396
Other Study ID Numbers 2015 / 1769
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Contribution to the SECRETO study
Current Responsible Party Haukeland University Hospital
Original Responsible Party Same as current
Current Study Sponsor Haukeland University Hospital
Original Study Sponsor Same as current
Collaborators Helsinki University Central Hospital
Investigators
Principal Investigator: Ulrike Waje-Andreassen, MD, PhD Haukeland University Hospital
PRS Account Haukeland University Hospital
Verification Date May 2016