NOR-SYS: The Norwegian Stroke in the Young Study

Haukeland University Hospital

Status: Active, not recruiting

Conditions: Carotid Artery Disease; Death; Peripheral Artery Disease; Cardiovascular Disease

Treatments: Behavioral: Lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01597453

2010/74

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,062 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,062 participants in 1 patient group

Lifestyle counseling

Other group

Description:

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

Treatment:

Behavioral: Lifestyle counseling