MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway

NCT03962127 | Active Not Recruiting

• 1 other identifier: 2015/453
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 8

Brief Summary

Annually 13000 Norwegians experience an ischemic stroke. The number of stroke is anticipated to increase with 50% within 2030 due to a growing number of elderly. Many of them will have severe function deficits and reduced quality of life. The investigators have established a cohort consisting of 800 patients with first time ischemic stroke treated at hospitals in Central Norway. The investigators want to study the incidence and prognostic markers for death, recurrent stroke and severe functional deficits during a period of 10 years after the initial ischemic stroke. The investigators want to focus on the impact of physical functioning, the level of physical activity and use of medication for secondary prevention on the incidence of death, recurrent stroke and severe functional deficits. The investigators are especially interested in the importance of fulfilling the treatment targets for blood pressure and cholesterol and the importance of smoking cessation in stroke survivors. Our objective is to improve todays stroke treatment and achieve a more efficient use of the health resources in order to increase survival after stroke maintaining a good physical and psychological function and quality of life.

Conditions

Stroke; Cardiovascular Diseases; Cardiovascular Risk Factor; Brain Ischemia; Cerebrovascular Disorders; Nervous System Diseases; Central Nervous System Lymphoma; Pathologic Processes; Vascular Diseases

Keywords

Cardiovascular risk factors; Risk Assessment; Severity of Illness Index; Mortality; Recurrent stroke; Health-related quality of life; modified Rankin scale; NIHSS; Fatigue severity score; Hospital anxiety and depression scale; Montreal cognitive assessment

Outcome Measures

Primary Outcomes (20)

• The incidence of recurrent stroke after first ever ischemic stroke

  Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires

  3 months

• The incidence of recurrent stroke after first ever ischemic stroke

  Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires

  1 year

• The incidence of recurrent stroke after first ever ischemic stroke

  Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires

  3 years

• The incidence of recurrent stroke after first ever ischemic stroke

  Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires

  5 years

• The incidence of recurrent stroke after first ever ischemic stroke

  Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires

  10 years

• Mortality after first ischemic stroke

  Measured with data from Norwegian Death Registry

  3 months

• Mortality after first ischemic stroke

  Measured with data from Norwegian Death Registry

  1 year

• Mortality after first ischemic stroke

  Measured with data from Norwegian Death Registry

  3 years

• Mortality after first ischemic stroke

  Measured with data from Norwegian Death Registry

  5 years

• Mortality after first ischemic stroke

  Measured with data from Norwegian Death Registry

  10 years

• Functional disability after stroke

  Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)

  3 months after stroke

• Functional disability after stroke

  Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6,value above 2 represents a worse outcome)

  1 year after stroke

• Functional disability after stroke

  Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)

  3 years after stroke

• Functional disability after stroke

  Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)

  5 years after stroke

• Functional disability after stroke

  Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)

  10 years after stroke

• Health-related quality of life after stroke

  EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 2 represents reduced life quality)

  3 months after stroke

• Health-related quality of life after stroke

  EQ-5D-5L(5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)

  1 year after stroke

• Health-related quality of life after stroke

  EQ-5D-5L(5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)

  3 years after stroke

• Health-related quality of life after stroke

  EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)

  5 years after stroke

• Health-related quality of life after stroke

  EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)

  10 years after stroke

Secondary Outcomes (2)

• Cost-benefit analysis

  1, 5 and 10 years

• Proportion of patients reaching secondary prevention targets

  3 months, 1, 3, 5 and 10 years

Study Arms (1)

First time ischemic stroke

Patients with a first event of ischemic stroke admitted to hospitals in Central Norway.

Other: no intervention

Interventions

no intervention OTHER

no intervention

First time ischemic stroke

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in a hospital in Central Norway for first time ischemic stroke.

You may qualify if:

• Cerebral infarction according to ICD-10 CM code I63
• \> 18 years of age
• First time stroke resident in Central-Norway
• Recruited within a time frame of 7 days of hospital admission.

You may not qualify if:

• Focal neurological symptoms turned out to be not stroke-related
• Significant physical disabilities prior to stroke (defined as Modified Rankin ≥5).

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator
• Helse Midt-Norge: collaborator

Study Sites (8)

Ålesund Sykehus

Ålesund, Norway

Location

Kristiansund Sykehus

Kristiansund, Norway

Location

Levanger Sykehus

Levanger, Norway

Location

Molde Sykehus

Molde, Norway

Location

Namsos Sykehus

Namsos, Norway

Location

Orkdal Sykehus

Orkanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Volda Sykehus

Volda, Norway

Location

Biospecimen

Retention: NONE RETAINED

Blood samples

MeSH Terms

Conditions

Stroke; Cardiovascular Diseases; Brain Ischemia; Cerebrovascular Disorders; Nervous System Diseases; Pathologic Processes; Vascular Diseases; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Bent Indredavik, PhD Prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 23, 2019
• Study Start: May 1, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (8)