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

• Sponsor: County Clinical Emergency Hospital Cluj-Napoca (Other)
• Overall Status: Completed
• CT.gov ID: NCT03584126
• Collaborator: (none)
• Enrollment: 123
• Location: 1
• Actual Duration (Months): 40.2
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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	Phase
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

• 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: Apr 25, 2017
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Arms and Interventions

Arm	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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	County Clinical Emergency Hospital of Cluj-Napoca	Cluj-Napoca	Cluj	Romania	400006

Sponsors and Collaborators

• County Clinical Emergency Hospital Cluj-Napoca

Investigators

• Principal Investigator: Zoltán Bálint, PhD, County Clinical Emergency Hospital Cluj-Napoca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: County Clinical Emergency Hospital Cluj-Napoca
• ClinicalTrials.gov Identifier: NCT03584126
• Other Study ID Numbers: 20117/04.10.2016
• First Posted: Jul 12, 2018
• Last Update Posted: Sep 11, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Sep 11, 2020