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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03413072
Enrollment
140
Registered
2018-01-29
Start date
2018-06-30
Completion date
2020-06-30
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Correlation of the level of galectin-3 in the blood with changes in activated partial thromboplastin timeOne year

Contacts

Primary ContactMahmoud Raafat Abdel-fadeil, MD
mrafadeil@gmail.com0201001644429
Backup ContactSalah-eldin Sayed Atta, MD
salah_s_atta@hotmail.com0201091318801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026