Atrial FibrillationNCT03413072
Galectin-3 for Thromboembolic Formation in Patients With Atrial Fibrillation CHA₂DS₂-VASc Scoring
An observational study of Atrial Fibrillation and Stroke, run by Assiut University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with non valvular atrial fibrillation either paroxysmal or persistent types above 18 years.
Who may be able to join
- Gender: men and women.
- Age >18 years.
- Diagnosed as non valvular atrial fibrillation patients either paroxysmal or persistent types.
Who cannot join
- pregnancy
- valvular heart diseases.
- Congenital heart diseases.
- Heart failure.
- Ischemic heart disease.
- Inflammatory diseases.
- Cancer.
- Thyroid disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Galectin-3 as a Predictor for Thromboembolic Formation in Patients With Non Valvular Atrial Fibrillation Assessed by CHA₂DS₂-VASc Scoring
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Stroke
- Medical subject headings
- Atrial Fibrillation, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
Correlation of the level of galectin-3 in the blood with changes in activated partial thromboplastin time
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study startJun 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma El-sayed Moustafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413072
- Sponsor's protocol ID
- G-3A
- Status last verified
- Jan 2018
- First submitted
- 16 Jan 2018
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1866765Magnani 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.
PubMed 22042927Lip 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.
PubMed 19762550Chao 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.
PubMed 22871677Henderson 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.
PubMed 16549783McCullough 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.
PubMed 22249510O'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.
PubMed 27013611
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galectin-3 as a Predictor for Thromboembolic Formation in Patients With Non Valvular Atrial Fibrillation Assessed by CHA₂DS₂-VASc Scoring
- ClinicalTrials.gov ID
- NCT03413072
- Acronym / sponsor ID
- G-3A
- Conditions
- Atrial Fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non valvular atrial fibrillation either paroxysmal or persistent types above 18 years.
Key inclusion criteria (3 listed)
- Gender: men and women.
- Age >18 years.
- Diagnosed as non valvular atrial fibrillation patients either paroxysmal or persistent types.
Key exclusion criteria (8 listed)
- pregnancy
- valvular heart diseases.
- Congenital heart diseases.
- Heart failure.
- Ischemic heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: one year
1 secondary outcome
Correlation of the level of galectin-3 in the blood with changes in activated partial thromboplastin time
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Background: PubMed 1866765Wolf 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.
- Background: PubMed 22042927Magnani 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.
- Background: PubMed 19762550Lip 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.
- Background: PubMed 22871677Chao 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.
- Background: PubMed 16549783Henderson 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.
- Background: PubMed 22249510McCullough 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.
- Background: PubMed 27013611O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Raafat Abdel-fadeil, MD (0201001644429, mrafadeil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03413072, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.