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OpenTrials
Completed

NCT Number: NCT03584126

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

County Clinical Emergency Hospital of Cluj-Napoca

Cluj-Napoca, Cluj, 400006, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Electrocardiography, ecocardiography and MRI.

Diagnostic Test

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.

Primary outcomes

  1. Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation.

    Time frame: 2016-2020

    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.

Secondary outcomes

  1. Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers.

    Time frame: 2016-2020

    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.

Sponsors and collaborators

Lead sponsor

County Clinical Emergency Hospital Cluj-Napoca

Other

Registry information

Official study title

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

Acronym: imATFIB

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2018
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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