NOR-SYS: The Norwegian Stroke in the Young Study

Study Overview
=================
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.

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

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

Conditions
-----------------
Death, Carotid Artery Disease, Cardiovascular Disease, Peripheral Artery Disease

Intervention / Treatment
-----------------
* Behavioral: Lifestyle counseling


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lifestyle counseling<br>There are no different arms, NOR-SYS is an observational study | Behavioral: Lifestyle counseling<br>* Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling<br>* Other names: NOR-SYS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Outcome measure is assessed every five years. | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease | Outcome measure is assessed every five years. | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Young ischemic stroke, Families, Long-term follow-up