NCT03584126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

3.4 years

First QC Date

June 19, 2018

Last Update Submit

September 10, 2020

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation.

    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.

    2016-2020

Secondary Outcomes (1)

  • Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers.

    2016-2020

Study Arms (2)

Patients with AF

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

Diagnostic Test: Electrocardiography, ecocardiography and MRI.

Control

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

Diagnostic Test: Electrocardiography, ecocardiography and MRI.

Interventions

Electrocardiography, ecocardiography and MRI.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.

ControlPatients with AF

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult population presented at the cardiologist with persistent, permanent or paroxysmal atrial fibrillation (AF).

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

County Clinical Emergency Hospital of Cluj-Napoca

Cluj-Napoca, Cluj, 400006, Romania

Location

Related Publications (1)

  • 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.

    PMID: 41010636DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

ElectrocardiographyMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisTomographyDiagnostic Imaging

Study Officials

  • Zoltán Bálint, PhD

    County Clinical Emergency Hospital Cluj-Napoca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 12, 2018

Study Start

April 25, 2017

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)