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NOR-SYS: The Norwegian Stroke in the Young Study

This study is currently recruiting participants.
Verified November 2012 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01597453
First received: May 2, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Death
Carotid Artery Disease
Cardiovascular Disease
Peripheral Artery Disease
 Behavioral: Lifestyle counseling
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    Outcome measure is assessed every five years.


Secondary Outcome Measures:
  • Arterial events (recurrent stroke or TIA, myocardial infarction or angina, peripheral artery disease [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    Outcome measure is assessed every five years.


Estimated Enrollment: 600
Study Start Date: September 2010
Estimated Study Completion Date: December 2035
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lifestyle counseling Behavioral: Lifestyle counseling
Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling
Other Name: NOR-SYS

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
  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597453

Contacts
Contact: Ulrike Waje-Andreassen, MD, PhD +4755975045 ulrike.andreassen@helse-bergen.no
Contact: Annette Fromm, MD +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
Investigators
Principal Investigator: Ulrike Waje-Andreassen, MD, PhD Haukeland UH
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01597453     History of Changes
Other Study ID Numbers: 2010/74
Study First Received: May 2, 2012
Last Updated: November 27, 2012
Health Authority: Norway: Regional Ethics Commitee

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

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

ClinicalTrials.gov processed this record on May 23, 2013