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Inflammation, Fibrosis and Risk of Recurrence After Atrial Fibrillation Ablation (FIBRO-RISK)

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ClinicalTrials.gov Identifier: NCT03757741
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
University of Targu Mures, Romania
University Hospital of Targu Mures, Romania
Information provided by (Responsible Party):
Cardio Med Medical Center

Brief 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)

Condition or disease Intervention/treatment
Atrial Fibrillation Atrial Inflammation Diagnostic Test: Cardiac imaging tests Diagnostic Test: Venous blood samle collection

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Inflammation-mediated Myocardial Fibrosis on the Risk of Recurrence After Successful Ablation of Atrial Fibrillation - the FIBRO-RISK Study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
AF-SG 01
Study subjects with atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation
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.

AF-SG 02
Study subjects without atrial fibrillation recurrence after ablation: Blood sampling (assessment of complete blood count, biochemistry, inflammatory biomarkers), 2D transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance, and complex left and right atrium analysis, Pulmonary vein isolation radiofrequency ablation
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.




Primary Outcome Measures :
  1. The rate of AF recurrence after pulmonary vein isolation [ Time Frame: 12 months ]
    The primary outcome measure will be represented by the rate of AF recurrence at 1 year post ablation, documented by either ECG or Holter monitoring.


Secondary Outcome Measures :
  1. Rate of re-hospitalization [ Time Frame: 12 months ]
    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)

  2. Rate of survival without relapse [ Time Frame: 12 months ]
    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)

  3. Rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke) [ Time Frame: 12 months ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Study population includes patients from a single center with paroxysmal and persistent atrial fibrillation, meeting inclusion and exclusion criteria and undergoing pulmonary vein isolation radiofrequency catheter ablation.
Criteria

Inclusion Criteria:

  • Patients with non-valvular paroxysmal or persistent atrial fibrillation who undergo successful ablation of atrial fibrillation, either by cryoablation or by radiofrequency advanced 3D mapping system;
  • Ability to provide informed consent;
  • Patients aged at least 18 years;

Exclusion Criteria:

  • Patients with valvular atrial fibrillation;
  • Patients with acute coronary syndrome in the last 30 days
  • Patients in whom atrial fibrillation is presumed to be caused by hyperthyreosis
  • Patients with long-standing persistent or permanent atrial fibrillation;
  • Unwillingness or incapacity to provide informed consent;
  • Allergy to gadolinium contrast media;
  • Absolute or relative contraindications to magnetic resonance imaging
  • Pregnancy or lactation;
  • Women with childbearing potential in absence of any contraceptive treatment
  • Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis;
  • Active malignancy or malignancy within the last 5 year prior to enrollment;
  • Conditions associated with an estimated life expectancy of under 2 years;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757741


Contacts
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Contact: Szilamér Korodi, MD +40 753609570 szilamerkorodi@yahoo.com
Contact: Theodora Benedek, Professor theodora.benedek@gmail.com

Locations
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Romania
Cardio Med Medical Center Recruiting
Targu Mures, Mures, Romania, 540102
Contact: Theodora Benedek, Professor         
Sponsors and Collaborators
Cardio Med Medical Center
University of Targu Mures, Romania
University Hospital of Targu Mures, Romania
Investigators
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Principal Investigator: Szilamér Korodi, M.D. University of Medicine and Pharmacy of Tirgu Mures, Romania
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Responsible Party: Cardio Med Medical Center
ClinicalTrials.gov Identifier: NCT03757741    
Other Study ID Numbers: CM0318-FIR
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication will be available for interested parties.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: The IPD sharing frame is starting 6 months after publication.
Keywords provided by Cardio Med Medical Center:
atrial fibrillation recurrence
atrial volume
atrial fibrosis
epicardial adipose tissue
inflammatory biomarkers
late gadolinium-enhancement cardiac magnetic resonance
pulmonary vein isolation
Additional relevant MeSH terms:
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Atrial Fibrillation
Inflammation
Fibrosis
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes