NOR-SYS: The Norwegian Stroke in the Young Study (NOR-SYS)
Primary Purpose
Death, Carotid Artery Disease, Cardiovascular Disease
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
About this trial
This is an interventional diagnostic trial for Death focused on measuring Young ischemic stroke, Families, Long-term follow-up
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
Sites / Locations
- Dep. of Neurology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lifestyle counseling
Arm Description
There are no different arms, NOR-SYS is an observational study
Outcomes
Primary Outcome Measures
All cause mortality
Outcome measure is assessed every five years.
Secondary Outcome Measures
Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease
Outcome measure is assessed every five years.
Full Information
NCT ID
NCT01597453
First Posted
May 2, 2012
Last Updated
March 4, 2019
Sponsor
Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01597453
Brief Title
NOR-SYS: The Norwegian Stroke in the Young Study
Acronym
NOR-SYS
Official Title
NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2035 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Death, Carotid Artery Disease, Cardiovascular Disease, Peripheral Artery Disease
Keywords
Young ischemic stroke, Families, Long-term follow-up
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1062 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Other
Arm Description
There are no different arms, NOR-SYS is an observational study
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Other Intervention Name(s)
NOR-SYS
Intervention Description
Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling
Primary Outcome Measure Information:
Title
All cause mortality
Description
Outcome measure is assessed every five years.
Time Frame
20 years
Secondary Outcome Measure Information:
Title
Arterial events (recurrent stroke or transitory ischemic attack, myocardial infarction or angina, peripheral artery disease
Description
Outcome measure is assessed every five years.
Time Frame
20 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Waje-Andreassen, MD, PhD
Organizational Affiliation
Haukeland UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Neurology
City
Bergen
ZIP/Postal Code
5053
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
29334265
Citation
Oftedal A, Gerdts E, Waje-Andreassen U, Fromm A, Naess H, Linde A, Saeed S. Prevalence and covariates of uncontrolled hypertension in ischemic stroke survivors: the Norwegian stroke in the young study. Blood Press. 2018 Jun;27(3):173-180. doi: 10.1080/08037051.2018.1425827. Epub 2018 Jan 15.
Results Reference
derived
PubMed Identifier
27504830
Citation
Oygarden H, Fromm A, Sand KM, Kvistad CE, Eide GE, Thomassen L, Naess H, Waje-Andreassen U. A Family History of Stroke Is Associated with Increased Intima-Media Thickness in Young Ischemic Stroke - The Norwegian Stroke in the Young Study (NOR-SYS). PLoS One. 2016 Aug 9;11(8):e0159811. doi: 10.1371/journal.pone.0159811. eCollection 2016.
Results Reference
derived
PubMed Identifier
25884546
Citation
Oygarden H, Fromm A, Sand KM, Eide GE, Thomassen L, Naess H, Waje-Andreassen U. Stroke patients' knowledge about cardiovascular family history - the Norwegian Stroke in the Young Study (NOR-SYS). BMC Neurol. 2015 Mar 12;15:30. doi: 10.1186/s12883-015-0276-6.
Results Reference
derived
PubMed Identifier
25405619
Citation
Saeed S, Waje-Andreassen U, Fromm A, Oygarden H, Kokorina MV, Naess H, Gerdts E. Early vascular aging in young and middle-aged ischemic stroke patients: the Norwegian Stroke in the Young Study. PLoS One. 2014 Nov 18;9(11):e112814. doi: 10.1371/journal.pone.0112814. eCollection 2014.
Results Reference
derived
PubMed Identifier
24669965
Citation
Fromm A, Haaland OA, Naess H, Thomassen L, Waje-Andreassen U. Risk factors and their impact on carotid intima-media thickness in young and middle-aged ischemic stroke patients and controls: the Norwegian Stroke in the Young Study. BMC Res Notes. 2014 Mar 26;7:176. doi: 10.1186/1756-0500-7-176.
Results Reference
derived
PubMed Identifier
23865483
Citation
Fromm A, Thomassen L, Naess H, Meijer R, Eide GE, Krakenes J, Vedeler CA, Gerdts E, Larsen TH, Kuiper KK, Laxdal E, Russell D, Tatlisumak T, Waje-Andreassen U. The Norwegian Stroke in the Young Study (NOR-SYS): rationale and design. BMC Neurol. 2013 Jul 17;13:89. doi: 10.1186/1471-2377-13-89.
Results Reference
derived
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NOR-SYS: The Norwegian Stroke in the Young Study
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