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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03584126
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
County Clinical Emergency Hospital Cluj-Napoca

Study Description
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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.

Condition or disease Intervention/treatment
Atrial Fibrillation Diagnostic Test: Electrocardiography, ecocardiography and MRI.

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.
Study Design
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Study Type : Observational
Actual Enrollment : 123 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation - imATFIB
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
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.
 Diagnostic Test: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation. [ Time Frame: 2016-2020 ]

    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.



Secondary Outcome Measures :
  1. Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers. [ Time Frame: 2016-2020 ]

    A. 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.



Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult population presented at the cardiologist with persistent, permanent or paroxysmal atrial fibrillation (AF).
Criteria

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).
Contacts and Locations
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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): NCT03584126


Locations
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Romania
County Clinical Emergency Hospital of Cluj-Napoca
Cluj-Napoca, Cluj, Romania, 400006
Sponsors and Collaborators
County Clinical Emergency Hospital Cluj-Napoca
Investigators
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Principal Investigator: Zoltán Bálint, PhD County Clinical Emergency Hospital Cluj-Napoca
More Information
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Responsible Party: County Clinical Emergency Hospital Cluj-Napoca
ClinicalTrials.gov Identifier: NCT03584126    
Other Study ID Numbers: 20117/04.10.2016
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes