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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Electrocardiography, ecocardiography and MRI.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • County Clinical Emergency Hospital of Cluj-Napoca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult population presented at the cardiologist with persistent, permanent or paroxysmal atrial fibrillation (AF).

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with AF; Patients with atrial fibrillation visiting the outpatient clinic; examined by general examination, electrocardiography, ecocardiography and MRI.	Diagnostic test: Electrocardiography, ecocardiography and MRI.; 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.
Control; Healthy adult volunteers; examined by the study physicians by general examination, electrocardiography, ecocardiography and MRI.	Diagnostic test: Electrocardiography, ecocardiography and MRI.; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: County Clinical Emergency Hospital Cluj-Napoca
• Investigators: Principal Investigator: Zoltán Bálint, PhD, County Clinical Emergency Hospital Cluj-Napoca

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 20117/04.10.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No