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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03584126
Acronym
imATFIB
Enrollment
123
Registered
2018-07-12
Start date
2017-04-25
Completion date
2020-08-31
Last updated
2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

DIAGNOSTIC_TESTElectrocardiography, 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.

Sponsors

County Clinical Emergency Hospital Cluj-Napoca
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation.2016-2020A. 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

MeasureTime frameDescription
Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers.2016-2020A. 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.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026