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NCT Number: NCT01597453

NOR-SYS: The Norwegian Stroke in the Young Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Death Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Disease Cardiovascular Diseases Carotid Artery Disease Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Neurology

Bergen, 5053, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling

Other names: NOR-SYS

Primary outcomes

  1. All cause mortality

    Time frame: 15 years for patients and partners and 20 years for offspring

    Outcome measure is assessed every five years.

Secondary outcomes

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

    Time frame: 15 years for patients and partners and 20 years for offspring

    Outcome measure is assessed every five years.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors

Acronym: NOR-SYS

Important dates

Study start
2010
Primary completion
2015
Study completion
2030
First posted
May 14, 2012
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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