Atrial FibrillationANATOLI-AFNCT03560219
Association of Genetic Polymorphisms With Atrial Fibrosis and Thrombogenic Substrate in Patients With Non-valvular Atrial Fibrillation
An observational study of Atrial Fibrillation and Thrombosis, run by Memorial Ankara Hospital.
Trial summary
Atrial fibrillation (AF) is the most frequently encountered cardiac arrhythmia. Emerging data suggests that common genetic variants are associated with the development of AF. The main feature of the structural remodelling in AF is atrial fibrosis and is considered the substrate for AF perpetuation. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Atrial Fibrillation, Thrombosis, Stroke
- What is being tested?
- Biomarkers, Cardiac Magnetic Resonance Imaging, Echocardiography, Flow Mediated Dilatation, Genetic Analysis
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Dec 2019
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population will include patients with documented AF (Paroxysmal or Persistent) over the age of 18. Patients are planned to be recruited from four major cardiology departments: Memorial Ankara Hospital, Ministry of Health Subspecialty Training Hospital of Turkey, Ufuk University and Gazi University hospitals.
Who may be able to join
- >18 years
- Documented AF
- Paroxysmal and persistent AF
Who cannot join
- Patients with infectious or non-infectious inflammatory disease
- Patients with structural heart disease
- Acute coronary syndrome
- Severe liver and kidney dysfunction
- Cancer
- Immune disorders
- Surgery and stroke within six months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: AssociatioN of Genetic Polymorphisms With ATrial fibrOsis and Thrombogenic Substrate in Patients With Non-vaLvular atrIAl Fibrillation
Atrial fibrillation (AF) is the most frequently encountered cardiac arrhythmia. Emerging data suggests that common genetic variants are associated with the development of AF. The main feature of the structural remodelling in AF is atrial fibrosis and is considered the substrate for AF perpetuation. Genome-wide association studies suggest that AF-susceptibility variants may modulate atrial fibrosis. However, the association between atrial fibrosis and genetic polymorphisms in humans has not yet been specifically investigated. In this study, we plan to investigate the relationship between genetic polymorphisms, atrial fibrosis and other components of thrombogenic substrate in patients with non-valvular AF. Primary objectives of this study are to assess associations between (i) polymorphic genetic variants and atrial fibrosis (detected by magnetic resonance imaging), (ii) polymorphic genetic variants and components of thrombogenic substrate (inflammation, endothelial function, prothrombotic state, atrial functions).
Read the detailed description
Atrial fibrillation (AF) is the most frequently encountered cardiac arrhythmia. Emerging data suggests that common genetic variants are associated with the development of AF. The main feature of the structural remodelling in AF is atrial fibrosis and is considered the substrate for AF perpetuation. Genome-wide association studies suggest that AF-susceptibility variants may modulate atrial fibrosis. However, the association between atrial fibrosis and genetic polymorphisms in humans has not yet been specifically investigated. In this study, we plan to investigate the relationship between genetic polymorphisms, atrial fibrosis and other components of thrombogenic substrate in patients with non-valvular AF. Primary objectives of this study are to assess associations between (i) polymorphic genetic variants and atrial fibrosis (detected by magnetic resonance imaging), (ii) polymorphic genetic variants and components of thrombogenic substrate (inflammation, endothelial function, prothrombotic state, atrial functions). Patients are planned to be recruited from four major cardiology departments: Memorial Ankara Hospital, Ministry of Health Subspecialty Training Hospital of Turkey, Ufuk University and Gazi University hospitals. Key variables that will be recorded include the clinical, contrast-enhanced MRI, biomarkers, echocardiographic and assessment of endothelial function. All statistical analyses will be conducted using Stata version 11.0 (StataCorp, College Station, TX). Univariate and multivariate regression models will be used to determine the odds ratio of each variable to assess the association of the clinical and laboratory parameters, and genotype profiles with the presence of LA fibrosis. Furthermore, data mining methods like support vector machines and/or random forests are planned to be used for detecting the impact of each potential predictor on the risk of LA fibrosis. Additionally, to determine the effect of different alleles of the identified risk SNPs, 2-way and 3-way multi dimensionality reduction (MDR) analysis will be performed. Bioinformatics investigations to determine SNP-SNP, SNP-gene and SNP-Phenotype interactions will be performed by combined p-value and biological network analysis.
- Conditions
- Atrial Fibrillation, Thrombosis, Stroke, Genetic Predisposition, Heart Diseases
- Being tested
- Biomarkers, Cardiac Magnetic Resonance Imaging, Echocardiography, Flow Mediated Dilatation, Genetic Analysis
- Keywords
- Atrial Fibrillation, Atrial Fibrosis, Genome Wide Association Studies, Biomarkers, Echocardiography, Magnetic Resonance Imaging, Flow Mediated Dilatation, Thrombogenic Substrate
- Medical subject headings
- Atrial Fibrillation, Thrombosis, Stroke, Genetic Predisposition to Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers, Cardiac Magnetic Resonance Imaging, Echocardiography, Flow Mediated Dilatation, Genetic AnalysisDiagnostic test
Key variables that will be recorded include the following:
- Clinical
- Age
- Gender
- BMI
- Diabetes Mellitus
- Hypertension
- Heart Failure
- Ischemic Stroke / TIA
- Thromboembolism
- Coronary Artery Disease
- Peripheral Arterial Disease
- Glomerular Filtration Rate
- Contrast-enhanced MRI
- Presence and extent of atrial fibrosis
- Biomarkers
- IL-6
- CRP
- D-dimer
- Fibrinogen
- Transthoracic Echocardiography
- LA Volume Index (LAVI)
- LA Strain, Global
- LA Strain rate, Positive peak, Global
- LA Strain rate, early negative peak, Global
- LA Strain rate, late negative peak, Global
- LA Emptying Fraction (LAEF)
- LVH
- LVEF
- Endothelial function o FMD
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations between polymorphic genetic variants and atrial fibrosis
(detected by MRI)
Measured: Through study completion, an average of 1 year
Associations between polymorphic genetic variants and components of thrombogenic substrate
Thrombogenic substrate (inflammation, endothelial function, prothrombotic state, atrial functions)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sercan Okutucu, Memorial Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560219
- Sponsor's protocol ID
- MANK200801
- Acronym
- ANATOLI-AF
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AssociatioN of Genetic Polymorphisms With ATrial fibrOsis and Thrombogenic Substrate in Patients With Non-vaLvular atrIAl Fibrillation
- ClinicalTrials.gov ID
- NCT03560219
- Acronym / sponsor ID
- ANATOLI-AF / MANK200801
- Conditions
- Atrial Fibrillation, Thrombosis, Stroke, Genetic Predisposition, Heart Diseases
- Keywords
- Atrial Fibrillation, Atrial Fibrosis, Genome Wide Association Studies, Biomarkers, Echocardiography, Magnetic Resonance Imaging, Flow Mediated Dilatation, Thrombogenic Substrate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Memorial Ankara HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 18 Jun 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 (AF) is the most frequently encountered cardiac arrhythmia. Emerging data suggests that common genetic variants are associated with the development of AF. The main feature of the structural remodelling in AF is atrial fibrosis and is considered the substrate for AF perpetuation. Genome-wide association studies suggest that AF-susceptibility variants may modulate atrial fibrosis. However, the association between atrial fibrosis and genetic polymorphisms in humans has not yet been specifically investigated. In this study, we plan to investigate the relationship between genetic polymorphisms, atrial fibrosis and other components of thrombogenic substrate in patients with non-valvular AF. Primary objectives of this study are to assess associations between (i) polymorphic genetic variants and atrial fibrosis (detected by magnetic resonance imaging), (ii) polymorphic genetic variants and components of thrombogenic substrate (inflammation, endothelial function, prothrombotic state, atrial functions).
Detailed description
Atrial fibrillation (AF) is the most frequently encountered cardiac arrhythmia. Emerging data suggests that common genetic variants are associated with the development of AF. The main feature of the structural remodelling in AF is atrial fibrosis and is considered the substrate for AF perpetuation. Genome-wide association studies suggest that AF-susceptibility variants may modulate atrial fibrosis. However, the association between atrial fibrosis and genetic polymorphisms in humans has not yet been specifically investigated. In this study, we plan to investigate the relationship between genetic polymorphisms, atrial fibrosis and other components of thrombogenic substrate in patients with non-valvular AF. Primary objectives of this study are to assess associations between (i) polymorphic genetic variants and atrial fibrosis (detected by magnetic resonance imaging), (ii) polymorphic genetic variants and components of thrombogenic substrate (inflammation, endothelial function, prothrombotic state, atrial functions). Patients are planned to be recruited from four major cardiology departments: Memorial Ankara Hospital, Ministry of Health Subspecialty Training Hospital of Turkey, Ufuk University and Gazi University hospitals. Key variables that will be recorded include the clinical, contrast-enhanced MRI, biomarkers, echocardiographic and assessment of endothelial function. All statistical analyses will be conducted using Stata version 11.0 (StataCorp, College Station, TX). Univariate and multivariate regression models will be used to determine the odds ratio of each variable to assess the association of the clinical and laboratory parameters, and genotype profiles with the presence of LA fibrosis. Furthermore, data mining methods like support vector machines and/or random forests are planned to be used for detecting the impact of each potential predictor on the risk of LA fibrosis. Additionally, to determine the effect of different alleles of the identified risk SNPs, 2-way and 3-way multi dimensionality reduction (MDR) analysis will be performed. Bioinformatics investigations to determine SNP-SNP, SNP-gene and SNP-Phenotype interactions will be performed by combined p-value and biological network analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will include patients with documented AF (Paroxysmal or Persistent) over the age of 18. Patients are planned to be recruited from four major cardiology departments: Memorial Ankara Hospital, Ministry of Health Subspecialty Training Hospital of Turkey, Ufuk University and Gazi University hospitals.
Key inclusion criteria (3 listed)
- >18 years
- Documented AF
- Paroxysmal and persistent AF
Key exclusion criteria (7 listed)
- Patients with infectious or non-infectious inflammatory disease
- Patients with structural heart disease
- Acute coronary syndrome
- Severe liver and kidney dysfunction
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarkers, Cardiac Magnetic Resonance Imaging, Echocardiography, Flow Mediated Dilatation, Genetic AnalysisKey variables that will be recorded include the following: * Clinical * Age * Gender * BMI * Diabetes Mellitus * Hypertension * Heart Failure * Ischemic Stroke / TIA * Thromboembolism * Coronary Artery Disease * Peripheral Arterial Disease * Glomerular Filtration Rate * Contrast-enhanced MRI o Presence and extent of atrial fibrosis * Biomarkers * IL-6 * CRP * D-dimer * Fibrinogen * Transthoracic Echocardiography * LA Volume Index (LAVI) * LA Strain, Global * LA Strain rate, Positive peak, Global * LA Strain rate, early negative peak, Global * LA Strain rate, late negative peak, Global * LA Emptying Fraction (LAEF) * LVH * LVEF * Endothelial function o FMD | Diagnostic test | – |
Primary outcome
Associations between polymorphic genetic variants and atrial fibrosis
Time frame: Through study completion, an average of 1 year
(detected by MRI)
Associations between polymorphic genetic variants and components of thrombogenic substrate
Time frame: Through study completion, an average of 1 year
Thrombogenic substrate (inflammation, endothelial function, prothrombotic state, atrial functions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- 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 Thrombosis, run by Memorial Ankara Hospital.
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 7 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 19 Jun 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 Sercan Okutucu, MD, FACC (00903122536666 ext. 4207, sercanokutucu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associations between polymorphic genetic variants and atrial fibrosis (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2018.