Galectin-3 for Thromboembolic Formation in Patients With Atrial Fibrillation CHA₂DS₂-VASc Scoring

Stroke Clinical Trial

Official title:

Galectin-3 as a Predictor for Thromboembolic Formation in Patients With Non Valvular Atrial Fibrillation Assessed by CHA₂DS₂-VASc Scoring

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03413072
• Other study ID #: G-3A
• Status: Not yet recruiting
• Phase: N/A
• First received: January 16, 2018
• Last updated: January 22, 2018
• Start date: June 2018
• Est. completion date: June 2020

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: Mahmoud Raafat Abdel-fadeil, MD
• Phone: 0201001644429
• Email: mrafadeil[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Atrial Fibrillation is considered as one of a common cardiac arrhythmia that presented with rapid and irregular rhythm and has an increased incidence.There are different types of atrial fibrillation one of these is paroxysmal atrial fibrillation that defined as lasts longer than 30 seconds and lasting less than 7 days, while atrial fibrillation lasting more than 7 days to less than one year or requiring pharmacological or electrical cardioversion is called persistent atrial fibrillation, referring to the American Heart Association 2006 guidelines.Patients with atrial fibrillation suffer from serious complications like stroke due to thromboembolism, heart failure and death. Risk of stroke is 5-folds in patients with atrial fibrillation in addition to presence or absence of another clinical risk factors.

Description:

In 2001, the CHADS₂ score (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke) was developed to predict the risk of stroke in patients with non rheumatic atrial fibrillation.In this score, each patient giving one point for congestive heart failure , hypertension , age equal or more than 75 years, diabetes mellitus and two points for stroke, transient ischemic attack.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: June 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Gender: men and women.

2. Age >18 years.

3. Diagnosed as non valvular atrial fibrillation patients either paroxysmal or persistent types.

Exclusion Criteria:

1. pregnancy

2. valvular heart diseases.

3. Congenital heart diseases.

4. Heart failure.

5. Ischemic heart disease.

6. Inflammatory diseases.

7. Cancer.

8. Thyroid disease.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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. Epub 2012 Aug 7. — View Citation

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. Epub 2006 Mar 20. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. Erratum in: Rev Cardiovasc Med. 2012;13(1):e52. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of Galectin-3 blood Level with the risk of thromboembolic complications among patients with paroxysmal and persistent atrial fibrillation as assessed by CHA2DS2-VASc scoring.		one year
Secondary	Correlation of the level of galectin-3 in the blood with changes in activated partial thromboplastin time		One year