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

Atrial Fibrillation Clinical Trial

— imATFIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584126
• Other study ID #: 20117/04.10.2016
• Status: Completed
• Start date: April 25, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: County Clinical Emergency Hospital Cluj-Napoca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Romania	County Clinical Emergency Hospital of Cluj-Napoca	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
County Clinical Emergency Hospital Cluj-Napoca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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