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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

  • - 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.

Exclusion criteria:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03962127
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Norwegian University of Science and Technology
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bent Indredavik, PhD Prof
Principal Investigator Affiliation Norwegian University of Science and Technology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

MIDNOR STROKE is a descriptive prospective longitudinal cohort study, which includes patients with a first event of ischemic stroke admitted to hospitals in Central Norway. The overall objective of this study is to complete a 10-year follow-up of patients with ischemic stroke. Patient recruitment started 01.09.2015 and ended 01.11.2017. During this time-period, a total of 802 patients were recruited. Patient follow-up at 3 months is completed and follow-up at 12 months will be completed 01.11.18. All participants met the following inclusion criteria; cerebral infarction according to ICD-10 CM code I63, > 18 years of age, first time stroke, resident in Central-Norway and recruited within a timeframe of 7 days of hospital admission. Patients were excluded if focal neurological symptoms turned out to be not stroke-related or if there were significant physical disabilities prior to stroke (defined as Modified Rankin ≥5) Eligible stroke patients were recruited during acute stay in hospital. Written informed consent was obtained from all potential stroke patients and from their legal caretakers (mostly a close family member), admitted to the hospital and each subject signed an informed consent form. All participants were examined and treated in line with The Recommended Guidelines for treatment and rehabilitation of stroke, which includes clinical examinations, blood tests, assessment of risk profile and additional relevant examinations. Stroke patients were recruited and patient data collected by a designated nurse during the initial stay at the hospital. Either a nurse or research assistant in the project performed patient follow-up at 3 and 12 months. Data collected at 3 months included data from a clinical and physical assessment, interview, questionnaires and medical records. Follow-up data at 12 months is collected by phone interview and questionnaires. The data have been collected at baseline, 3

  • - and 12 months.
Further data collection is planned at 3, 5 and 10 years. The comprehensive data collection in MIDNOR STROKE at baseline includes data on pre-stroke function (Barthel index, Nottingham ADL, Modified rankin scale), life style risk factors, stroke severity (NIHSS, SSS, TOAST classifications), previous disease, vital signs (i.e. blood pressure, pulse, oxygen saturation), blood values, complications during hospital stay, medication and medical images during hospital stay. Assessment at 3 months included information on physical function, physical activity (HUNT
  • - International physical activity questionnaire), cognitive function (Montreal cognitive assessment), depression (Hospital and anxiety and depression scale), fatigue (Fatigue severity score) and health related quality of life (EQ- 5D- 5L).
Data collection at 12 months includes data on physical function, medication, depression, fatigue and health related quality of life. Additional data will be collected from the Norwegian Stroke Registry, The Norwegian Patient registry, The Norwegian cardiovascular disease registry and The Norwegian Cause of Death registry. The overall aim for MIDNOR STROKE is to establish a cohort of patients with first- time stroke to study the occurrence and predictors for recurrent stroke, mortality, physical activity, disability and the quality of life during a 10-year period. MIDNOR STROKE contains six work packages, which address the key areas of interest in the project: 1. Recurrent stroke, mortality, disability and quality of life after stroke. 2. Secondary prevention of stroke in relation to recurrent stroke, mortality, disability and quality of life. 3. Physical activity and function among stroke patients. 4. Prediction models for recurrent stroke, disability and quality of life after stroke. 5. Pathophysiologic mechanisms of acute ischemic stroke. 6. Stroke health economics, health care resources cost and use

Arms & Interventions

Arms

: First time ischemic stroke

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

Interventions

Other: - no intervention

no intervention

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kristiansund Sykehus, Kristiansund, Norway

Status

Address

Kristiansund Sykehus

Kristiansund, ,

Levanger Sykehus, Levanger, Norway

Status

Address

Levanger Sykehus

Levanger, ,

Molde Sykehus, Molde, Norway

Status

Address

Molde Sykehus

Molde, ,

Namsos Sykehus, Namsos, Norway

Status

Address

Namsos Sykehus

Namsos, ,

Orkdal Sykehus, Orkanger, Norway

Status

Address

Orkdal Sykehus

Orkanger, ,

St Olavs Hospital, Trondheim, Norway

Status

Address

St Olavs Hospital

Trondheim, ,

Volda Sykehus, Volda, Norway

Status

Address

Volda Sykehus

Volda, ,

Ålesund Sykehus, Ålesund, Norway

Status

Address

Ålesund Sykehus

Ålesund, ,

Resources

  • Patient and Caregiver Survey
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  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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