Galectin-3 for Thromboembolic Formation in Patients With Atrial Fibrillation CHA₂DS₂-VASc Scoring
NCT ID: NCT03413072
Last Updated: 2018-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
140 participants
OBSERVATIONAL
2018-06-30
2020-06-30
Brief Summary
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Detailed Description
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In 2010, CHADS₂ was expanded to include three additional independent risk factors: vascular disease (coronary artery disease, peripheral artery disease, aortic atherosclerosis), age 65-74 years, and female sex. So new, more inclusive scoring system is the CHA₂DS₂-VASc. Each patient giving one point for congestive heart failure, hypertension, diabetes mellitus, vascular disease, age 65-74 and female gender and two point for history of stroke, transient ischemic attack and age≥75.
The CHA₂DS₂-VASc score is better to predict stroke risk in non valvular atrial fibrillation patients with a baseline CHADS₂ score of 0 to 1. The 2014 American Heart Association/ American College of Cardiology/ Heart Rhythm Society guidelines also recommend the CHA₂DS₂-VASc for stroke risk in patients with non valvular atrial fibrillation. The 2016 European Society of Cardiology guidelines recommend using the CHA₂DS₂-VASc score to predict stroke risk in atrial fibrillation patients and to give oral anticoagulants to men with a score of 1 or higher and women with a score of 2 or higher.
Stroke is a serious vascular problem, 25-30 percent of the cause is atrial fibrillation inspite of paroxysmal or persistent types.
Galectin-3 is known as a soluble beta-galactoside binding lectin that secreted by immune cell and mediates profibrotic pathways. Also it has a role in inflammation, cell proliferation, and tissue repair. So, it is involved in multiple diseases as liver, kidney, inflammatory disease.
In cardiac disease, it has a role in pathophysiology of atrial fibrillation, heart failure, myocardial infarction as the level is found high in patients with ST segment elevation myocardial infarction than normal persons and according to the level the outcome of disease is suggested.
Also if galectin-3 is greater than the median level, the patients have a higher risk of new or recurrent heart failure. Galectin-3 has been approved by the Food and Drug Administration as a prognostic biomarker in congested heart failure to be used in conjunction with clinical evaluation.
Galectin-3 has an ability of binding to von willbrand factor so help in modulation of early thrombus formation, as the glycans on human factor VIII are similar to von willbrand factor.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
2. Age \>18 years.
3. Diagnosed as non valvular atrial fibrillation patients either paroxysmal or persistent types.
Exclusion Criteria
2. valvular heart diseases.
3. Congenital heart diseases.
4. Heart failure.
5. Ischemic heart disease.
6. Inflammatory diseases.
7. Cancer.
8. Thyroid disease.
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Fatma El-sayed Moustafa
principal investigator
Central Contacts
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References
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Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. doi: 10.1161/01.str.22.8.983.
Magnani JW, Rienstra M, Lin H, Sinner MF, Lubitz SA, McManus DD, Dupuis J, Ellinor PT, Benjamin EJ. Atrial fibrillation: current knowledge and future directions in epidemiology and genomics. Circulation. 2011 Nov 1;124(18):1982-93. doi: 10.1161/CIRCULATIONAHA.111.039677.
Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010 Feb;137(2):263-72. doi: 10.1378/chest.09-1584. Epub 2009 Sep 17.
Chao TF, Liu CJ, Chen SJ, Wang KL, Lin YJ, Chang SL, Lo LW, Hu YF, Tuan TC, Wu TJ, Chen TJ, Tsao HM, Chen SA. Atrial fibrillation and the risk of ischemic stroke: does it still matter in patients with a CHA2DS2-VASc score of 0 or 1? Stroke. 2012 Oct;43(10):2551-5. doi: 10.1161/STROKEAHA.112.667865. Epub 2012 Aug 7.
Henderson NC, Mackinnon AC, Farnworth SL, Poirier F, Russo FP, Iredale JP, Haslett C, Simpson KJ, Sethi T. Galectin-3 regulates myofibroblast activation and hepatic fibrosis. Proc Natl Acad Sci U S A. 2006 Mar 28;103(13):5060-5. doi: 10.1073/pnas.0511167103. Epub 2006 Mar 20.
McCullough PA, Olobatoke A, Vanhecke TE. Galectin-3: a novel blood test for the evaluation and management of patients with heart failure. Rev Cardiovasc Med. 2011;12(4):200-10. doi: 10.3909/ricm0624.
O'Sullivan JM, Jenkins PV, Rawley O, Gegenbauer K, Chion A, Lavin M, Byrne B, O'Kennedy R, Preston RJ, Brophy TM, O'Donnell JS. Galectin-1 and Galectin-3 Constitute Novel-Binding Partners for Factor VIII. Arterioscler Thromb Vasc Biol. 2016 May;36(5):855-63. doi: 10.1161/ATVBAHA.115.306915. Epub 2016 Mar 24.
Other Identifiers
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G-3A
Identifier Type: -
Identifier Source: org_study_id
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