Ischemic Stroke at a Young Age Clinical Trial
— NOR-SYSIIOfficial title:
The Norwegian Stroke in the Young Study II
| NCT number | NCT02762396 |
| Other study ID # | 2015 / 1769 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 1, 2016 |
| Est. completion date | February 28, 2022 |
| Verified date | May 2023 |
| Source | Haukeland University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
NOR-SYS II is designed for finding the cause of acute ischemic stroke lesions in Young adults, age 15 to 49 years. Risk factors, arterial wall changes by intima-media thickness and plaques and consequences of stroke are examined by standardized diagnostics.
| Status | Completed |
| Enrollment | 130 |
| Est. completion date | February 28, 2022 |
| Est. primary completion date | February 28, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years to 49 Years |
| Eligibility | Inclusion Criteria: - Documented acute, arterial ischemic stroke - Speaks Norwegian fluently Exclusion Criteria: - Post-traumatic and procedure related stroke - Sinus venous thrombosis, sepsis and endocarditis - Serious co-morbidity, such as advanced cancer with "end-of-life stroke". - Patients mentally retarded or with severe psychiatric disease who do not accept the diagnosis and who would need sedation to perform clinical diagnostics. |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Dep. of Neurology | Bergen |
| Lead Sponsor | Collaborator |
|---|---|
| Haukeland University Hospital | Helsinki University Central Hospital |
Norway,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Established atherosclerosis | The ultrasound protocol of the NOR-SYS study will be applied for carotid and femoral arteries. In addition angiographies will be done for patients with suspicious arterial disease. The measurements will be done within hospital stay after the acute stroke. | Established atherosclerosis will serve as outcome measure for data collected during hospital stay and will be related to risk factors. The data will be presented one year after finishing the 5-years of inclusion of the whole study group. | |
| Secondary | New cardiovascular events | Patients With different causes of ischemic stroke have different prognosis that is worst for recurrent stroke and other cardiovascular events for patients with atherosclerosis. | One year after the stroke | |
| Secondary | Death | Death fro all causes with subgroups of cardiovascular death, cancer and other causes of death will be registered | One year after the stroke | |
| Secondary | Alive but not back to previous education or full-time job | Not back to work because of stroke related problems. Standardized questionnaires will be used to collect information about education and work before stroke and the situation after 3 months and one year. The frequency and reasons why patients did not come back to their education situation or their job they did before the stroke are collected. We expect that it is still possible within a year from stroke onset, to specify the sort of problem related to stroke or unrelated to stroke. This may get more unspecific, the longer the time gets from stroke onset to follow-up. NOR-SYS II will focus on a particular group of patients that seem to function well but that struggle with unvisible problems such as tiredness and reduced capacity / energy to work. | One year after the stroke |