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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 : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Tracking Information
First Submitted Date  ICMJE May 2, 2012
First Posted Date  ICMJE May 14, 2012
Last Update Posted Date March 7, 2019
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
All cause mortality [ Time Frame: 20 years ]
Outcome measure is assessed every five years.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2012)
Arterial events (recurrent stroke or TIA, myocardial infarction or angina, peripheral artery disease [ Time Frame: 20 years ]
Outcome measure is assessed every five years.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NOR-SYS: The Norwegian Stroke in the Young Study
Official Title  ICMJE NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Death
  • Carotid Artery Disease
  • Cardiovascular Disease
  • Peripheral Artery Disease
Intervention  ICMJE Behavioral: Lifestyle counseling
Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling
Other Name: NOR-SYS
Study Arms  ICMJE Lifestyle counseling
There are no different arms, NOR-SYS is an observational study
Intervention: Behavioral: Lifestyle counseling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 19, 2016)
1062
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2012)
600
Estimated Study Completion Date  ICMJE December 2035
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01597453
Other Study ID Numbers  ICMJE 2010/74
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulrike Waje-Andreassen, MD, PhD Haukeland UH
PRS Account Haukeland University Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP