NOR-SYS: The Norwegian Stroke in the Young Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Haukeland University Hospital
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01597453
First received: May 2, 2012
Last updated: July 7, 2013
Last verified: July 2013

May 2, 2012
July 7, 2013
September 2010
August 2015   (final data collection date for primary outcome measure)
All cause mortality [ Time Frame: 20 years ] [ Designated as safety issue: No ]
Outcome measure is assessed every five years.
Same as current
Complete list of historical versions of study NCT01597453 on ClinicalTrials.gov Archive Site
Arterial events (recurrent stroke or TIA, myocardial infarction or angina, peripheral artery disease [ Time Frame: 20 years ] [ Designated as safety issue: No ]
Outcome measure is assessed every five years.
Same as current
Not Provided
Not Provided
 
NOR-SYS: The Norwegian Stroke in the Young Study
NOR-SYS: The Norwegian Stroke in the Young Study Young Ischemic Stroke and Family Risk Factors

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.

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
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
  • Death
  • Carotid Artery Disease
  • Cardiovascular Disease
  • Peripheral Artery Disease
Behavioral: Lifestyle counseling
Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling
Other Name: NOR-SYS
Lifestyle counseling
Intervention: Behavioral: Lifestyle counseling
Fromm A, Haaland ØA, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2035
August 2015   (final data collection date for primary outcome measure)

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
Both
15 Years to 60 Years
Yes
Contact: Ulrike Waje-Andreassen, MD, PhD +4755975045 ulrike.andreassen@helse-bergen.no
Contact: Annette Fromm, MD +4755975045 annette.fromm@helse-bergen.no
Norway
 
NCT01597453
2010/74
No
Haukeland University Hospital
Haukeland University Hospital
Not Provided
Principal Investigator: Ulrike Waje-Andreassen, MD, PhD Haukeland UH
Haukeland University Hospital
July 2013

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