Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Diagnostic Test: Electrocardiography, ecocardiography and MRI.
- Registration Number
- NCT03584126
- Lead Sponsor
- County Clinical Emergency Hospital Cluj-Napoca
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Electrocardiography, ecocardiography and MRI. Healthy adult volunteers; examined by the study physicians by general examination, electrocardiography, ecocardiography and MRI. Patients with AF Electrocardiography, ecocardiography and MRI. Patients with atrial fibrillation visiting the outpatient clinic; examined by general examination, electrocardiography, ecocardiography and MRI.
- Primary Outcome Measures
Name Time Method Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation. 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 Outcome Measures
Name Time Method Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers. 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.
Trial Locations
- Locations (1)
County Clinical Emergency Hospital of Cluj-Napoca
🇷🇴Cluj-Napoca, Cluj, Romania