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

NCT ID: NCT03584126

Last Updated: 2020-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-25

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with AF

Patients with atrial fibrillation visiting the outpatient clinic; examined by general examination, electrocardiography, ecocardiography and MRI.

Electrocardiography, ecocardiography and MRI.

Intervention Type DIAGNOSTIC_TEST

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.

Control

Healthy adult volunteers; examined by the study physicians by general examination, electrocardiography, ecocardiography and MRI.

Electrocardiography, ecocardiography and MRI.

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

County Clinical Emergency Hospital Cluj-Napoca

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zoltán Bálint, PhD

Role: PRINCIPAL_INVESTIGATOR

County Clinical Emergency Hospital Cluj-Napoca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

County Clinical Emergency Hospital of Cluj-Napoca

Cluj-Napoca, Cluj, Romania

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Romania

References

Explore related publications, articles, or registry entries linked to this study.

Manole S, Pintican R, Budurea C, Pop S, Iancu SD, Popa L, Coman M, Schiau C, Coman V, Schiau S, Balint Z. Increased Left Ventricular Mass Index and Atrial Volume Index Are Associated with Atrial Fibrosis in Patients with Atrial Fibrillation. J Clin Med. 2025 Sep 12;14(18):6432. doi: 10.3390/jcm14186432.

Reference Type DERIVED
PMID: 41010636 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20117/04.10.2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.