Atrial FibrillationimATFIBNCT03584126
Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation
An observational study of Atrial Fibrillation, run by County Clinical Emergency Hospital Cluj-Napoca at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Electrocardiography, ecocardiography and MRI.
- How many people
- 123 participants
- Where
- 1 siteRomania
- Study dates
- 25 Apr 2017to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult population presented at the cardiologist with persistent, permanent or paroxysmal atrial fibrillation (AF).
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Romania1 site
County Clinical Emergency Hospital of Cluj-Napoca
Cluj-Napoca, Cluj, 400006
About this study
Official title: Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation - imATFIB
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Electrocardiography, ecocardiography and MRI.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with AF | Patients with atrial fibrillation visiting the outpatient clinic; examined by general examination, electrocardiography, ecocardiography and MRI. Receives: Diagnostic Test: Electrocardiography, ecocardiography and MRI. | |
| Control | Healthy adult volunteers; examined by the study physicians by general examination, electrocardiography, ecocardiography and MRI. Receives: Diagnostic Test: Electrocardiography, ecocardiography and MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation.
- Percentage of patients with left atrial fibrosis assessed by MRI among those with persistent atrial fibrillation.
- Correlation of the left atrial fibrosis localization and amount with persistent atrial fibrillation severity.
Measured: 2016-2020
Secondary outcomes (1)
Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers.
- Correlation of left atrial fibrosis with left atrial dimensions in patients and healthy volunteers.
- Correlation of left atrial fibrosis with blood bio-marker levels and echocardiography parameters in patients and healthy volunteers.
Measured: 2016-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start25 Apr 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- County Clinical Emergency Hospital Cluj-Napoca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zoltán Bálint, PhD, Principal investigator, County Clinical Emergency Hospital Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584126
- Sponsor's protocol ID
- 20117/04.10.2016
- Acronym
- imATFIB
- Status last verified
- Sep 2020
- First submitted
- 19 Jun 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41010636
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation - imATFIB
- ClinicalTrials.gov ID
- NCT03584126
- Acronym / sponsor ID
- imATFIB / 20117/04.10.2016
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- County Clinical Emergency Hospital Cluj-NapocaUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with AF | – | Diagnostic Test: Electrocardiography, ecocardiography and MRI.Patients with atrial fibrillation visiting the outpatient clinic; examined by general examination, electrocardiography, ecocardiography and MRI. |
| Control | – | Diagnostic Test: Electrocardiography, ecocardiography and MRI.Healthy adult volunteers; examined by the study physicians by general examination, electrocardiography, ecocardiography and MRI. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population presented at the cardiologist with persistent, permanent or paroxysmal atrial fibrillation (AF).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Control, Patients with AF |
Primary outcome
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.
1 secondary outcome
Specificity of left atrial fibrosis for persistent atrial fibrillation by comparing fibrosis in patients and healthy volunteers.
Time frame: 2016-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Derived from this study: PubMed 41010636Manole 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.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoltán Bálint, PhD principal investigator
County Clinical Emergency Hospital Cluj-Napoca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by County Clinical Emergency Hospital Cluj-Napoca at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the presence, localization and quantity of left atrial fibrosis assessed by MRI in patients with persistent atrial fibrillation. (time frame: 2016-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.