Research project overview

The Nordic Atrial Fibrillation and Stroke Study
(NOR-FIB1
)

Sponsor: Oslo University Hospital

Protocol number: REK2013/2371

ClinicalTrials.gov Identifier: NCT02937077

Study design:

International multi-center prospective observational study of the occurrence of AF in patients with cryptogenic stroke / TIA. Patients will be monitored with implantable cardiac monitors (ICMs) for   12 months and blood samples measuring biomarkers in the acute phase and at 12 months follow-up.

Objective:

To assess the incidence of AF detection using ICM (Reveal LINQ®) in patients with cryptogenic stroke or TIA.

To identify biomarkers that can be used as predictors of incident AF.

Number of subjects: 500

Number of centers: Up to 30

Duration of study participation:

Enrollment: approximately 18 months.

Follow-up period: 12 months ± 20 days.

Total study duration: 30 months.

Primary endpoint:
AF detection rate within 12 months.

 

Secondary endpoint

  1. AF detection rate within 6 months.
  2. Levels of NT-proBNP and BNP.
  3. Levels of Troponin-T and Troponin-I.
  4. Levels of cardiovascular biomarkers.
  5. CHA2DS2-VASc score prior to stroke or TIA.
  6. Incidence of recurrent stroke or TIA within 12 months.
  7. Use and type of oral anticoagulation - percentage of patients who are using OAC drugs at the 12-month follow-up visit.
  8. Use of antiarrhythmic drugs - percentage of patients who are using antiarrhythmic drugs at the 12-month follow-up visit.
  9. Health Outcome as Evaluated by an EQ-5D Questionnaire - EQ-5D quality of life score, which is a continuous measure of quality of life. life score, which is a continuo

Fibrosis, inflammation and cerebral infarction in patients with atrial fibrillation - (The Norwegian Atrial Fibrillation and Stroke Study - NOR-FIB 2)

Sponsor: Oslo University Hospital

Protocol number: REK 2016/133

Sponsor: Oslo University Hospital and Østfold Hospital Trust

Study Design: The study is an observational prospective study of atrial fibrillation patients undergoing direct-current cardioversion. Protocol number: REK2013/2371

Primary Objective: To assess the prevalence and causes of new silent cerebral ischemic lesions after programmed direct-current cardioversion using diffusion-weighted sequences in brain MRI (DWMRI) and dual frequency transcranial Doppler.

Secondary Objectives:

  • To study the impact of inflammation measured by biomarkers and cardiac 18F-FDG-PET on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF.
  • To assess the impact of fibrosis measured by biomarkers on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF.
  • To assess cognitive and cerebral structural and metabolic changes after direct-current cardioversion for AF using cognitive assessments and cerebral and cardiac 18F-FDG-PET before and 12 months after treatment.

Number of Subjects: 70

Duration of Study: participation 18 months, follow-up period 12 months, total study duration 30 months

Study Centers:

  • Oslo University Hospital
  • Østfold Hospital Trust

Primary Endpoints:

  • Number of new small cerebral infarcts detected with DWMRI.

 

Secondary Endpoints:

  • Rate of AF recurrence
  • Degree of cardiac fibrosis
  • Level of inflammation biomarkers 
  • Level of fibrosis biomarkers
  • Cognitive function
  • Changes in uptake pattern on cerebral 18F-FDG-PET

 


 

The Oslo Acute Revascularization Stroke Study

Sponsor: Oslo University Hospital

Protocol number: REK 2015/1844                                    

Study Design: The study is an observational prospective study of acute ischemic stroke patients with proximal cerebral artery occlusion admitted to Oslo University Hospital for endovascular treatment.

Primary Objective:

  • To assess the clinical outcome of endovascular intervention in acute ischemic stroke patients in relation to time window, clinical severity, age, comorbidity and findings on brain MRI, including MR perfusion.

Secondary Objectives:

  • To assess the differences in the clinical outcome of endovascular therapy in patients admitted directly to the intervention center compared to patients from referral hospitals.
  • To assess pre-endovascular intervention logistics in order to identify unnecessary time-consuming procedure or actions.
  • To compare the effect of endovascular therapy on clinical outcome in patients who have received pretreatment with IV thrombolysis compared to those without pretreatment.
  • To assess the costs, quality of life and functional level in patients treated with endovascular intervention.
  • To assess the degree of poststroke inflammation and thrombotic activity using plasma biomarkers.
  • To relate degree of inflammation biomarkers in plasma to clinical outcome.

Number of Subjects: 200

Duration of Study: participation 24 months, follow-up period 12 months, total study duration 28 months

Study Centers:

  • Oslo University Hospital

Primary Endpoints:

  • 90-day global disability assessed with the blinded evaluation of the modified Rankin scale (mRS).

Secondary Endpoints:

  • Clinical Endoints
  • Safety Endpoints
  • Health Economic Evaluation:
  • Resource use

 


 

The DIRECT SAFE trial

The group is participating in the DIRECT SAFE trial - A randomized controlled trial of DIRECT endovascular clot retrieval versus standard bridging thrombolysis with endovascular clot retrieval within 4.5 hours of stroke onset. Anne Hege Aamodt is PI at Oslo University Hospital for this large multi-center thrombectomy trial that is lead from Melbourne.

 


 

The ELAN Trial

The group is participating in the ELAN trial: Early versus late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillatioN: an international, multicentre, randomised-controlled, two-arm, assessor-blinded trial.

 


 

Epidemiologic studies

All-In: HUNTing for genes affecting cerebrovascular diseases

The group is participating in the all-in HUNT 4 – The Nord-Trøndelag Health Study. 


The burden of brain diseases in Norway – a GBD 2016 project.

The group is participating in a project to the burden of brain diseases in Norway based on data from GBD 2016.

The Institute for Health Metrics and Evaluation (IHME) at the University of Washington is leading the Global Burden of Disease project. Everyone, all over the world, deserves to live a long life in full health. In order to achieve this goal, we need a comprehensive picture of what disables and kills people across countries, time, age, and sex. The Global Burden of Disease (GBD) provides a tool to quantify health loss from hundreds of diseases, injuries, and risk factors, so that health systems can be improved and disparities can be eliminated. In order to align health systems with the populations they serve, policymakers first need to understand the true nature of their country’s health challenges – and how those challenges are shifting over time. That means more than just estimating disease prevalence, such as the number of people with depression or diabetes in a population. GBD research incorporates both the prevalence of a given disease or risk factor and the relative harm it causes. The tools allow decision-makers to compare the effects of different diseases, such as malaria versus cancer, and then use that information at home. To make these results more accessible and useful, IHME has distilled large amounts of complicated information into a suite of interactive data visualizations that allow people to make sense of the over 1 billion data points generated. Collected and analyzed by a consortium of more than 2,300 researchers in more than 130 countries, the data capture premature death and disability from more than 300 diseases and injuries in 195 countries, by age and sex, from 1990 to the present, allowing comparisons over time, across age groups, and among populations. The flexible design of the GBD machinery allows for regular updates as new data and epidemiological studies are made available. In that way, the tools can be used at the global, national, and local levels to understand health trends over time, just like gross domestic product data are used to monitor a country’s economic activity.

Policymakers in countries worldwide are collaborating with GBD researchers to adopt this approach for measuring their population’s health and how it varies by different regions, socioeconomic status, or ethnic groups in their country.

 


 

The European Cerebrovascular Research Infrastructure www.ecri.no

ECRI is developed to facilitate large multi-center clinical cerebrovascular studies. The Norwegian Tenecteplase in stroke Trial (NOR-TEST) was the first multi-center study in ECRI to be completed in ECRI (http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(17)30253-3/fulltext).

 


 

The Norwegian Central Retinal Artery Occlusion and Thrombolysis Study (NOR-CRAOS) (www.ecri.no)

A prospective observational study of intravenous thrombolysis in nonartertitic Central Retinal Artery Occlusion and Thrombolysis Study.

 


 

SITS Oral anticoagulant study for secondary stroke prevention in NVAF patients hospitalized for an acute ischaemic stroke/TIA

SITS AF 1 Study

A retrospective and prospective study to identify the safest and most effective time point for initiation of oral anticoagulation (OAC) following ischaemic stroke of different severity in patients with atrial fibrillation.

SITS AF 2 Study

A retrospective and prospective study is to investigate the type, timing, safety and reasons for choice of acute interventions in patients taking direct OACs or warfarin prior to stroke onset.

 
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