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Status unknownNCT03560219ANATOLI-AFUpdated Jun 19, 2018

Association of Genetic Polymorphisms With Atrial Fibrosis and Thrombogenic Substrate in Patients With Non-valvular Atrial Fibrillation

An observational study in Atrial Fibrillation, Thrombosis and Stroke, sponsored by Memorial Ankara Hospital. Status unknown. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2018-06-19.

Sponsored by Memorial Ankara Hospital · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
225
Ages
17 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • 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
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 225 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

This is the only study on the registry with Memorial Ankara Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Inclusion criteria

  • >18 years
  • Documented AF
  • Paroxysmal and persistent AF

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
225 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testBiomarkers, Cardiac Magnetic Resonance Imaging, Echocardiography, Flow Mediated Dilatation, Genetic Analysis

    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 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

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What researchers measure

Primary outcomes

  1. Associations between polymorphic genetic variants and atrial fibrosis

    (detected by MRI)

    Time frame: Through study completion, an average of 1 year

  2. Associations between polymorphic genetic variants and components of thrombogenic substrate

    Thrombogenic substrate (inflammation, endothelial function, prothrombotic state, atrial functions)

    Time frame: Through study completion, an average of 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03560219
Lead sponsor
Memorial Ankara Hospital
Responsible party
Sercan Okutucu (Associate Professor, Memorial Ankara Hospital) — Principal investigator
First posted
Jun 18, 2018
Start date
Jul 1, 2018 (estimated)
Primary completion
Dec 1, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Jun 19, 2018

Study contacts

Sercan Okutucu, MD, FACC
Contact
sercanokutucu@yahoo.com
00903122536666 ext. 4207
Sercan Okutucu
Contact
sercanokutucu@yahoo.com
00903122536666 ext. 4207

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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