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NOR-SYS: The Norwegian Stroke in the Young Study

Sponsor
Haukeland University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01597453
Collaborator
(none)
1,062
Enrollment
1
Location
1
Arm
303
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

NOR-SYS is a clinical research program about young ischemic stroke patients from 15 to 60 years. Patients, partners and the couple´s adult children who are at least 18 years old, are all invited to ultrasound examinations due to a standardized protocol.

Parents of patients and partners are invited to return their answers of standardized questionnaires about clinical ischemic events such as stroke, angina or myocardial infarction or peripheral artery disease.

Study inclusion time of patients and their families is 5 years. A biobank is build from samples from patients, partners and adult children. Clinical follow-ups for patients and partners are planned after 5, 10 and 15 years. Clinical follow-ups for adult children are planned after 10 and 20 years.

Hypotheses:

What do patients know about their parents clinical ischemic events? How much established pathology in arteries do we find by a standardized ultrasound protocol at the time of ischemic stroke at a young age? Differences concerning risk factors and ultrasound findings between patients and partners? Differences between children from families with several ischemic events among parents and grandparents vs. children from families without ischemic events? Biochemical markers related to ultrasound findings and artery disease.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle counseling
 N/A

Detailed Description

Equal examinations for patients, partners and adult children are:

  • Standardized questionnaires

  • Extracranial duplexsonography

  • Duplexsonography of the abdominal aorta

  • Duplexsonography of femoral arteries

  • Duplexsonography of epicardial, intrabdominal and subcutaneous fat

  • Peripheral ultrasound, Ankle-arm index

  • ECG

  • Blood pressure measurement

  • BMI and Waist-hip ratio

  • Blood samples

Study Design

Study Type:
Interventional
Actual Enrollment :
1062 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2035

Arms and Interventions

Arm Intervention/Treatment
Other: Lifestyle counseling

There are no different arms, NOR-SYS is an observational study

Behavioral: Lifestyle counseling
Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling
Other Names:
  • NOR-SYS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. All cause mortality [20 years]

      Outcome measure is assessed every five years.

    Secondary Outcome Measures

    1. Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease [20 years]

      Outcome measure is assessed every five years.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Documented ischemic stroke at age from 15 up to 60 years
    Exclusion Criteria:

    • Stroke as end-of-life event among patients with cancer or other life-threatening disease

    • Stroke caused by trauma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dep. of Neurology Bergen Norway 5053

    Sponsors and Collaborators

    • Haukeland University Hospital

    Investigators

    • Principal Investigator: Ulrike Waje-Andreassen, MD, PhD, Haukeland UH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haukeland University Hospital
    ClinicalTrials.gov Identifier:
    NCT01597453
    Other Study ID Numbers:
    • 2010/74
    First Posted:
    May 14, 2012
    Last Update Posted:
    Mar 7, 2019
    Last Verified:
    Aug 1, 2018
    Keywords provided by Haukeland University Hospital
    Young ischemic stroke
    Families
    Long-term follow-up
    Additional relevant MeSH terms:
    Carotid Artery Diseases
    Cardiovascular Diseases
    Peripheral Arterial Disease

    Study Results

    No Results Posted as of Mar 7, 2019