Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent atrial fibrillation (AF). The result of the study is a diagnostic method which aids the medical work-up of patients suffering from this disease.

Detailed Description
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Atrial fibrillation (AF) is the most common arrhythmia associated with substantial morbidity and mortality in humans. Histopathological studies of persistent AF have reported extracellular matrix remodeling with fibrotic infiltration which may cause atrial dilation. The degree of the fibrosis might have a significant impact on wave propagation during AF. The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent AF. The obtained clinical parameters of patients and controls (electrocardiography, ecocardiography and MR imaging data) will be correlated with known markers in order to identify novel markers for AF diagnosis.

Official Title
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Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation - imATFIB

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: Electrocardiography, ecocardiography and MRI.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 20-80 years weight: 50-120 kg persistent, permanent or paroxysmal atrial fibrillation clinically stable patients: outside of an acute cardiac event with constant chronic medication optimum echographic window Exclusion Criteria: patients with: rheumatic mitral disease; acute myocardial-pericarditis; chronic rheumatism, under chronic or immunomodulatory treatment; infectious-inflammatory process of any cause patients undergoing oncology treatment patients under medication in another study patients undergoing immunosuppressive therapy contraindication for magnetic resonance imaging (MRI) patients with valvular prosthesis, pacemaker of any type, metallic elements in the body (including metal particles accidentally in the body or as a result of exercising certain professions); pregnant patients; patients with known poly-allergy; patients with altered renal function (creatinine clearance <40 mL/min determined by the Cockcroft-Gault formula).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with AF<br>Patients with atrial fibrillation visiting the outpatient clinic; examined by general examination, electrocardiography, ecocardiography and MRI. | Diagnostic Test: Electrocardiography, ecocardiography and MRI.<br>* AF patients and healthy adult volunteers will be examined by the study physicians and included in the study according to the inclusion criteria. After a general examination, an electrocardiography, an ecocardiography and an MRI will be performed on the AF-affected and healthy hearts, respectively.<br>|
| Control<br>Healthy adult volunteers; examined by the study physicians by general examination, electrocardiography, ecocardiography and MRI. | Diagnostic Test: Electrocardiography, ecocardiography and MRI.<br>* AF patients and healthy adult volunteers will be examined by the study physicians and included in the study according to the inclusion criteria. After a general examination, an electrocardiography, an ecocardiography and an MRI will be performed on the AF-affected and healthy hearts, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation. | A. Percentage of patients with left atrial fibrosis assessed by MRI among those with persistent atrial fibrillation. B. Correlation of the left atrial fibrosis localization and amount with persistent atrial fibrillation severity. | 2016-2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers. | A. Correlation of left atrial fibrosis with left atrial dimensions in patients and healthy volunteers. B. Correlation of left atrial fibrosis with blood bio-marker levels and echocardiography parameters in patients and healthy volunteers. | 2016-2020 |