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

NCT03560219 | Unknown DMC

• 1 other identifier: MANK200801
• Study Type: observational
• Target: 225
• Locations: 0 countries
• Sites: N/A

Brief 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).

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

Outcome Measures

Primary Outcomes (2)

• Associations between polymorphic genetic variants and atrial fibrosis

  (detected by MRI)

  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)

  Through study completion, an average of 1 year

Interventions

Biomarkers, Cardiac Magnetic Resonance Imaging, Echocardiography, Flow Mediated Dilatation, Genetic Analysis DIAGNOSTIC_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 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

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Ankara Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation; Thrombosis; Stroke; Genetic Predisposition to Disease; Heart Diseases

Interventions

Echocardiography; Genetic Testing

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Susceptibility; Disease Attributes

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Clinical Laboratory Techniques; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Central Study Contacts

Sercan Okutucu, MD, FACC

CONTACT

00903122536666; sercanokutucu@yahoo.com

Sercan Okutucu

CONTACT

00903122536666; sercanokutucu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: July 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share