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NOR-SYS: The Norwegian Stroke in the Young Study (NOR-SYS)

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ClinicalTrials.gov Identifier: NCT01597453
Recruitment Status : Active, not recruiting
First Posted : May 14, 2012
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

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
Death Carotid Artery Disease Cardiovascular Disease Peripheral Artery Disease Behavioral: Lifestyle counseling Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1062 participants
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 : September 2010
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2035

Arm Intervention/treatment
Lifestyle counseling Behavioral: Lifestyle counseling
Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling
Other Name: NOR-SYS




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 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 [ Time Frame: 20 years ]
    Outcome measure is assessed every five years.



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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01597453


Locations
Norway
Dep. of Neurology
Bergen, Norway, 5053
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Ulrike Waje-Andreassen, MD, PhD Haukeland UH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01597453     History of Changes
Other Study ID Numbers: 2010/74
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016

Keywords provided by Haukeland University Hospital:
Young ischemic stroke
Families
Long-term follow-up

Additional relevant MeSH terms:
Cardiovascular Diseases
Peripheral Arterial Disease
Carotid Artery Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Peripheral Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases