Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation - imATFIB
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Outcomes
Primary Outcomes
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
- Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers.(2016-2020)