NOR-SYS: The Norwegian Stroke in the Young Study

Cardiovascular Disease Clinical Trial

— NOR-SYS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01597453
• Other study ID #: 2010/74
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2010
• Est. completion date: December 2035

Study information

• Verified date: August 2018
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1062
• Est. completion date: December 2035
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Carotid Artery Disease
• Carotid Artery Diseases
• Death
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Behavioral:
• Lifestyle counseling
Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling

Locations

Country	Name	City	State
Norway	Dep. of Neurology	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Outcome measure is assessed every five years.	20 years
Secondary	Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease	Outcome measure is assessed every five years.	20 years