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Inflammation, Fibrosis and Risk of Recurrence After Atrial Fibrillation Ablation

NCT03757741 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-08-02

No results posted yet for this study

Summary

FIBRO-RISK study aims to investigate the impact of inflammatory-mediated myocardial fibrosis on the risk of recurrence after successful ablation of atrial fibrillation. The level of systemic inflammation in the pre-ablation and immediate post-ablation period will be assessed on the basis of serum levels of inflammatory biomarkers (hs-CRP, matrix metalloproteases, interleukin-6), while the level of cardiac fibrosis will be determined based on MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis at the level of left atrium and left ventricle. At the same time, the amount of epicardial fat will serve as an indirect marker of localized inflammation and will be determined at different levels in the heart (surrounding left atrium, right atrium or the entire heart), while ventricular function will be assessed on the basis of serum levels of NT pro-BNP prior to the procedure. All these parameters will be investigated in patients with successful ablation of AF, who will be divided into 2 groups: group 1 - patients who develop AF recurrence at 1-year, and group 2 - patients with no recurrence of AF at 1-year. In all patients, the following biomarkers will be determined: serum levels of inflammatory biomarkers and NT-proBNP at 24 hours and 1 year post-procedure, the amount of myocardial fibrosis at the level of left atrium and left ventricle at baseline +/- 7 days and the amount of epicardial fat surrounding left atrium, right atrium and the entire heart at baseline +/- 7 days.

The primary endpoint of the study will be represented by the rate of AF recurrence at 1-year post ablation, documented by either ECG or Holter monitoring.

The secondary endpoints of the study will be:

* rate of re-hospitalization
* rate of survival without relapse
* rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)

Conditions

Interventions

DIAGNOSTIC_TEST

Cardiac imaging tests

2D transthoracic echocardiography; Late gadolinium-enhancement cardiac magnetic resonance with the evaluation of pulmonary veins anatomy, atrial fibrosis, atrial volumes and the amount of epicardial fat will

DIAGNOSTIC_TEST

Venous blood samle collection

Venous blood sample collection 1 day prior to the ablation procedure: Serum levels of high sensitive C Reactive Protein, Matrix metalloproteases, Interleukin-6, and N-Terminal Pro-B-Type Natriuretic Peptide.

Sponsors & Collaborators

  • University of Targu Mures, Romania

    collaborator OTHER

  • University Hospital of Targu Mures, Romania

    collaborator OTHER

  • Cardio Med Medical Center

    lead INDUSTRY

Principal Investigators

  • Szilamér Korodi, M.D. · University of Medicine and Pharmacy of Tirgu Mures, Romania

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2021-02-01
Completion
2022-02-01

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03757741 on ClinicalTrials.gov