[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589046":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":22,"responsibleParty":52,"collaborators":56,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":10,"enrollmentInfo":82,"targetDuration":10,"studyType":85,"phases":10,"briefSummary":86,"conditions":87,"keywords":95,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Oral anticoagulant-naïve (OAC-naïve) patients with non-valvular atrial fibrillation (NVAF).",null,"The study population will consist of patients with newly diagnosed non-valvular atrial fibrillation (NVAF). Patients will have to be naïve to oral and parenteral anticoagulants prior to inclusion. Patients with newly diagnosed NVAF who are willing to participate in this study and sign the patient consent form will be scheduled for fast track outpatient clinic visit within four days for blood sampling, transthoracic echocardiography (TTE), and heart rhythm monitoring. OAC treatment will be initiated immediately after blood sampling, based on current guidelines for the management of NVAF. Demographic data will be collected, as well. Likewise, symptoms attributable to NVAF will be quantified according to the modified EHRA-score (European Heart Rhythm Association). Investigators will also determine whether hypertension and diabetes are effectively managed by home blood pressure (BP) measurements and HbA1c levels.",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Nedim Tojaga, Medical degree & PhD-student.","CONTACT","+4552752212","nedim.tojaga@rsyd.dk",{"name":19,"role":15,"phone":20,"phoneExt":10,"email":21},"Axel Brandes, Medical degree and Professor.","+4522903487","Axel.Brandes2@rsyd.dk",[23],{"facility":24,"status":25,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Esbjerg Hospital - University Hospital of Southern Denmark, involving collaboration between the Unit for Thrombosis Research, Department of Clinical Diagnostics and the Department of Cardiology.","RECRUITING","Esbjerg","Region Syddanmark","6700","Denmark","DK",{"type":32,"coordinates":33},"Point",[34,35],8.45187,55.47028,{"lat":35,"lon":34},[38,40,42,44,46,48,50],{"name":39,"role":15,"phone":16,"phoneExt":10,"email":17},"Nedim Tojaga, Medical degree and PhD-student",{"name":41,"role":15,"phone":20,"phoneExt":10,"email":21},"Axel Brandes, Medical degree and Professor",{"name":39,"role":43,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":41,"role":45,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":47,"role":45,"phone":10,"phoneExt":10,"email":10},"Anna-Marie Bloch Münster, CMO and Associate Professor",{"name":49,"role":45,"phone":10,"phoneExt":10,"email":10},"Else Marie Bladbjerg, Professor",{"name":51,"role":45,"phone":10,"phoneExt":10,"email":10},"Jeff Healey, Medical degree and Professor",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Nedim Tojaga","Principal investigator.",[57,59,62,64,66,68,70],{"name":58,"class":6},"Esbjerg Hospital - University Hospital of Southern Denmark",{"name":60,"class":61},"Karola Jørgensens Foundation and Foundation for Cardiology in Southwest Denmark.","UNKNOWN",{"name":63,"class":61},"Grosserer L.F. Foghts Foundation",{"name":65,"class":61},"Direktør Kurt Bønnelycke og Hustru fru Grethe Bønnelyckes Fond",{"name":67,"class":61},"The Faculty of Health Sciences SDU",{"name":69,"class":61},"Research Electronic Data Capture (REDCap)",{"name":71,"class":6},"Region of Southern Denmark","100589046","stroke-risk-assessment-and-markers-of-blood-clotting-in-patients-with-newly-diagnosed-non-valvular-atrial-fibrillation-nvaf-who-have-not-received-oral-anticoagulation-therapy-oac-therapy-prior-to-inclusion-100589046",false,"NCT06949319","Stroke Risk Assessment and Markers of Blood Clotting in Patients With Newly Diagnosed Non-valvular Atrial Fibrillation (NVAF), Who Have Not Received Oral Anticoagulation Therapy (OAC-therapy) Prior to Inclusion","Individualized Stroke Risk Scores and Hemostatic Profile in Oral Anticoagulant-naïve (OAC-naïve) Patients With Non-valvular Atrial Fibrillation (NVAF)","BIO-AF","Inclusion Criteria:\n\n* Patients with newly diagnosed non-valvular atrial fibrillation (NVAF), who are oral anticoagulant-naïve (OAC-naïve) prior to inclusion.\n* Age ≥ 18 years.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Ongoing OAC treatment prior to inclusion.\n* Valvular AF (mechanical heart valves or moderate-severe mitral stenosis).\n* Secondary AF due to an acute reversible precipitant (e.g., infection, surgery, thyrotoxicosis, etc.).\n* Pregnant or breastfeeding women.\n* Treatment with oral contraceptives.\n* End-stage renal disease (creatinine clearance \\\u003C15 mL\u002Fmin as calculated by the Cockcroft-Gault equation).\n* Connective tissue diseases.\n* Active cancer (cancer diagnosis not followed by curative procedures six months from the date of diagnosis).\n* Major surgery (\\\u003C three months).\n* Acute coronary syndrome, stroke\u002FTIA, and venous thromboembolism within three months prior to inclusion.\n* Thrombophilia.\n* Significant liver disease.\n* Significant hematological disease.","ALL","18 Years",{"count":83,"type":84},150,"ESTIMATED","OBSERVATIONAL","Background:\n\nAtrial fibrillation (AF) is the most common heart rhythm disorder worldwide. Globally, there are 37.5 million people with AF. AF increases the risk of death, heart failure, and stroke, which severely affect patients and also lead to high healthcare costs. Around 25% of all strokes are caused by AF, and patients with stroke due to AF tend to have a higher risk of death and more disability compared to stroke patients without AF.\n\nStroke prevention is, therefore, an important part of AF treatment, in which blood thinning medication has an important role. However, blood thinners increase the risk of bleeding. Therefore, it is important to divide patients with AF into different risk groups, known as risk assessment, to figure out who will benefit the most from blood thinners. To be able to divide patients into different risk groups, various stroke risk assessment tools have been developed, such as the CHA2DS2-VASc score and the ABC-stroke score. The most commonly used tool is the CHA2DS2-VASc score, including only clinical risk factors, such as high blood pressure, diabetes, etc. The ABC-stroke score, which includes blood markers of heart function, has been proven to outperform the CHA2DS2-VASc score in terms of predicting stroke in AF patients. However, the CHA2DS2-VASc score remains the primary stroke risk assessment tool for AF patients in current guidelines.\n\nAfter looking at the different risk factors, patients are divided into three groups: low, intermediate, and high risk. High-risk patients must take blood-thinning medication for life, while low-risk patients do not need it. In the medium-risk group, it remains uncertain whether blood thinners should be given or not.\n\nDespite the broad use of the CHA2DS2-VASc score, the score itself has limitations. The score does not include important factors, such as the duration of AF, the size and function of the upper heart chambers, as well as the stiffness of the heart, and markers of blood clotting, which are proven markers of a state that inceases the risk of blood clots. Furthermore, the CHA2DS2-VASc score does not consider whether heart failure, high blood pressure, and diabetes are well-controlled or not, which could lead to overuse of blood thinners. Therefore, the current risk assessment tools for patients with AF are incomplete, and improvements are needed.\n\nOverall hypothesis:\n\nOverall hypothesis is that the different components of the CHA2DS2-VASc score and ABC-stroke score affect blood clotting markers differently, depending on whether conditions like heart failure, high blood pressure, and diabetes (modifiable risk factors) are well-controlled or not. Investigators also expect to see differences in blood clotting markers across different stroke risk groups (low, intermediate, and high risk, based on the CHA2DS2-VASc score and ABC-stroke score) in AF patients who have not yet started blood thinning medication. Furthermore, investigators believe that the duration of AF, the size\u002Ffunction of the upper heart chambers, as well as the stiffness of the heart, can reflect an increased risk of blood clots in AF patients.\n\nOverall goal of the study:\n\nThe overall goal of the study is to help improve the current tools used to assess the risk of stroke in patients with newly diagnosed AF. This will be done by adding more factors to the current risk assessment tools that reflect an increased risk of stroke, such as the burden of AF, the size\u002Ffunction of the heart's upper chambers, as well as the stiffness of the heart, and using biomarkers that show the blood's ability to clot as a substitute measure for stroke risk.\n\nMethods:\n\nThe study is a cross-sectional, single-center observational study and will take place at Esbjerg Hospital - University Hospital of Southern Denmark, involving collaboration between the Unit for Thrombosis Research, Department of Clinical Diagnostics and the Department of Cardiology.\n\nThe study population will consist of 150 participants with newly diagnosed AF. The participants must not be taking a specific type of blood thinner, called anticoagulant therapy (OAC-therapy), before being included in the study. The participants will be recruited with the help of the general practitioners (GPs). The general practitioners will be thoroughly informed about the study and the importance of waiting to start OAC-therapy until the participants have been seen at the cardiology outpatient clinic. The participants will be scheduled for a blood test, an ultrasound of the heart (echocardiography), and a 7-day heart rhythm monitoring within 4 days after their first meeting with the GP.",[88,89,90,91,92,93,94],"Atrial Fibrillation (AF)","Atrial Fibrillation (Prevention of Stroke)","Atrial Fibrillation New Onset","Non Valvular Atrial Fibrillation","Stroke (in Patients With Atrial Fibrillation)","Stroke","Thrombosis",[96,97,98,99,100,101,102,103,104,105,106,93,107,108],"Stroke risk assessment in patients with atrial fibrillation","OAC-naïve patients with newly diagnosed atrial fibrillation","Hemostatic biomarkers","CHA2DS2-VASc score","ABC-stroke score","AF-burden","Left Atrial Function Index (LAFI)","Echocardiography","HFA-PEFF score","H2FPEF score","Heart failure with preserved ejection fraction (HFpEF)","Oral anticoagulant therapy","Non-valvular atrial fibrillation","2025-04-21",{"date":111,"type":112},"2025-04-29","ACTUAL",{"date":114,"type":112},"2024-08-16",{"date":116,"type":84},"2025-09",{"name":54,"class":6},1]