NOR-SYS: The Norwegian Stroke in the Young Study (NOR-SYS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01597453|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2012
Last Update Posted : February 22, 2016
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.
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 or disease||Intervention/treatment||Phase|
|Death Carotid Artery Disease Cardiovascular Disease Peripheral Artery Disease||Behavioral: Lifestyle counseling||Not Applicable|
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
- Blood pressure measurement
- BMI and Waist-hip ratio
- Blood samples
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1062 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2035|
Behavioral: Lifestyle counseling
Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling
Other Name: NOR-SYS
- All cause mortality [ Time Frame: 20 years ]Outcome measure is assessed every five years.
- Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease [ Time Frame: 20 years ]Outcome measure is assessed every five years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597453
|Dep. of Neurology|
|Bergen, Norway, 5053|
|Principal Investigator:||Ulrike Waje-Andreassen, MD, PhD||Haukeland UH|