Clinical trial NCT03584126: Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation
Official title: Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation - imATFIB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: County Clinical Emergency Hospital Cluj-Napoca
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adult population presented at the cardiologist with persistent, permanent or paroxysmal atrial fibrillation (AF).

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation.
timeFrame: 2016-2020
Secondary outcomes:
measure: Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers.
timeFrame: 2016-2020
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: County Clinical Emergency Hospital of Cluj-Napoca
state: Cluj
Study officials:
affiliation: County Clinical Emergency Hospital Cluj-Napoca
name: Zoltán Bálint, PhD
role: PRINCIPAL_INVESTIGATOR
References: