Atrial FibrillationSAFE-MRINCT05099783
Stepwise Strategy for Modifying Atrial Fibrillation Substrate Study - MRI
An observational study of Atrial Fibrillation, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
The investigators will conduct an observational trial, with outcome ascertainment at 3 months and 6 months after cardioversion. The primary objective is to demonstrate how cardioversion may aid in the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by late gadolinium… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- late gadolinium enhanced magnetic resonance imaging
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Candidate inpatients or outpatients will be identified if pharmacological or electrical cardioversion has be performed and LGE-MRI were performed after cardioversion at least twice.
Who may be able to join
- Patients carry a diagnosis of Persistent Atrial Fibrillation
- Patients have given informed consent
- Pharmacological or electrical cardioversion has be performed successfully
- late gadolinium enhanced magnetic resonance imaging (LGE-MRI) were performed after cardioversion at least twice
Who cannot join
- Prior radiofrequency ablation treatment for atrial fibrillation
- Prior cardiac surgical procedures
- Individuals with cognitive impairments who are unable to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Fang Qin, +8617308351199, qinfangheart@126.com
About this study
Official title: Stepwise Strategy for Modifying Atrial Fibrillation Substrate Study - Regression of Left Atrial Fibrosis Assessed by Late Gadolinium Enhanced Magnetic Resonance Imaging
The investigators will conduct an observational trial, with outcome ascertainment at 3 months and 6 months after cardioversion. The primary objective is to demonstrate how cardioversion may aid in the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging. The secondary objective is to assess the relationship between structural and functional changes with heart rhythm and heart rate.
Read the detailed description
Background: Atrial fibrillation (AF) is estimated to affect over 33 million people worldwide and is associated with significant co-morbidities such as embolic stroke, heart failure, dementia. Consequently, AF poses a significant burden to the healthcare system, in both direct and indirect costs. The management of AF is complex, especially for patients with persistent AF, which is defined as sustained AF for > 7 days. It is preferable to terminate the AF and restore normal sinus rhythm for relief of symptoms associated with AF or improvement of cardiac structure and function. The maintenance of AF, especially persist AF is associated with fibrosis of left atria. Furthermore, AF itself promotes fibrosis, which in turn leads to increased conduction heterogeneity within the atrial substrate resulting in further progression of AF. In animal models, alterations in myocytes after sustained AF resemble those of myocardial hibernation. Ultimately, these structural changes would lead to Calcium overload and metabolic stress, similar changes have been observed in humans. In humans, atrial dilatation and degenerative changes have been observed. Interstitial fibrosis is the prime cause of structural remodeling in left atrium. Whether reversal of sinus rhythm can reverse fibrosis partly? The introduction of Late Gadolinium enhancement magnetic resonance imaging (LGE-MRI) sequence now allows for non-invasive and dynamic assessment of the location and extent of atrial fibrosis.
To date, no studies evaluating the regression of left atrial fibrosis after cardioversion assessed by LGE-MRI have been performed. The investigators propose to use LGE-MRI to evaluate the effects of cardioversion on atrial fibrosis. It has been shown that the extent of fibrosis can predict the success of catheter ablation procedure. For these patients with more "scar", control the progression of fibrosis and simultaneously provide respite from AF recurrence would be an extremely desirable prescription.
Objectives: To determine the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.
Methods: This study will be an observational trial in patients with persist AF. Candidate inpatients or outpatients will be identified if MRI were performed after pharmacological or electrical cardioversion at least twice. The heart rhythm will be assessed by medical records and telephone survey.
Objective
Primary:
The primary objective of this study is to demonstrate how cardioversion may influence the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by LGE-MRI, using longitudinal data from a retrospective study of patients diagnosed with atrial fibrillation over a six month follow up period.
Secondary:
To study the effects of sinus rhythm in global parameters of myocardial remodeling such as right and left atrial volumes and right and left ventricular volumes.
To assess whether characteristics of MRI after cardioversion can predict the rate of atrial fibrillation sinus rhythm maintenance.
- Conditions
- Atrial Fibrillation
- Being tested
- late gadolinium enhanced magnetic resonance imaging
- Keywords
- Atrial Fibrillation, late gadolinium enhanced magnetic resonance imaging, atrial fibrosis
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
late gadolinium enhanced magnetic resonance imagingDiagnostic test
Candidate inpatients or outpatients will be identified if pharmacological or electrical cardioversion has be performed and MRI were performed after cardioversion at least twice.
What is being measured
The primary outcome is the main question the study is designed to answer.
The regression of left atrial fibrosis in patients with persist atrial fibrillation after cardioversion
The change in left atrial fibrosis (the core and border zone area, percentage of left atrium and segments involved) using MRI imaging, from baseline to the second measurement.
Measured: 3 to 6 months
Secondary outcomes (2)
The effects of sinus rhythm in global parameters of myocardial remodeling
The change in left atrial global parameters of MRI ( left atrial volume).
Measured: 3 to 6 months
The effects of sinus rhythm in global parameters of myocardial remodeling
The change in left atrial parameters of echocardiography.
Measured: 3 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Sep 2021
- Primary completion30 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuehui Yin, Study director, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099783
- Sponsor's protocol ID
- SAFE-LGEMRI
- Acronym
- SAFE-MRI
- Status last verified
- Jul 2022
- First submitted
- 18 Oct 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thijssen VL, Ausma J, Liu GS, Allessie MA, van Eys GJ, Borgers M. Structural changes of atrial myocardium during chronic atrial fibrillation. Cardiovasc Pathol. 2000 Jan-Feb;9(1):17-28. doi: 10.1016/s1054-8807(99)00038-1.
PubMed 10739903Hobbs WJ, Fynn S, Todd DM, Wolfson P, Galloway M, Garratt CJ. Reversal of atrial electrical remodeling after cardioversion of persistent atrial fibrillation in humans. Circulation. 2000 Mar 14;101(10):1145-51. doi: 10.1161/01.cir.101.10.1145.
PubMed 10715261Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.
PubMed 24496537
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepwise Strategy for Modifying Atrial Fibrillation Substrate Study - Regression of Left Atrial Fibrosis Assessed by Late Gadolinium Enhanced Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05099783
- Acronym / sponsor ID
- SAFE-MRI / SAFE-LGEMRI
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, late gadolinium enhanced magnetic resonance imaging, atrial fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 29 Oct 2021 (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 investigators will conduct an observational trial, with outcome ascertainment at 3 months and 6 months after cardioversion. The primary objective is to demonstrate how cardioversion may aid in the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging. The secondary objective is to assess the relationship between structural and functional changes with heart rhythm and heart rate.
Detailed description
Background: Atrial fibrillation (AF) is estimated to affect over 33 million people worldwide and is associated with significant co-morbidities such as embolic stroke, heart failure, dementia. Consequently, AF poses a significant burden to the healthcare system, in both direct and indirect costs. The management of AF is complex, especially for patients with persistent AF, which is defined as sustained AF for > 7 days. It is preferable to terminate the AF and restore normal sinus rhythm for relief of symptoms associated with AF or improvement of cardiac structure and function. The maintenance of AF, especially persist AF is associated with fibrosis of left atria. Furthermore, AF itself promotes fibrosis, which in turn leads to increased conduction heterogeneity within the atrial substrate resulting in further progression of AF. In animal models, alterations in myocytes after sustained AF resemble those of myocardial hibernation. Ultimately, these structural changes would lead to Calcium overload and metabolic stress, similar changes have been observed in humans. In humans, atrial dilatation and degenerative changes have been observed. Interstitial fibrosis is the prime cause of structural remodeling in left atrium. Whether reversal of sinus rhythm can reverse fibrosis partly? The introduction of Late Gadolinium enhancement magnetic resonance imaging (LGE-MRI) sequence now allows for non-invasive and dynamic assessment of the location and extent of atrial fibrosis.
To date, no studies evaluating the regression of left atrial fibrosis after cardioversion assessed by LGE-MRI have been performed. The investigators propose to use LGE-MRI to evaluate the effects of cardioversion on atrial fibrosis. It has been shown that the extent of fibrosis can predict the success of catheter ablation procedure. For these patients with more "scar", control the progression of fibrosis and simultaneously provide respite from AF recurrence would be an extremely desirable prescription.
Objectives: To determine the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.
Methods: This study will be an observational trial in patients with persist AF. Candidate inpatients or outpatients will be identified if MRI were performed after pharmacological or electrical cardioversion at least twice. The heart rhythm will be assessed by medical records and telephone survey.
Objective
Primary:
The primary objective of this study is to demonstrate how cardioversion may influence the regression of left atrial fibrosis in patients with persist atrial fibrillation as assessed by LGE-MRI, using longitudinal data from a retrospective study of patients diagnosed with atrial fibrillation over a six month follow up period.
Secondary:
To study the effects of sinus rhythm in global parameters of myocardial remodeling such as right and left atrial volumes and right and left ventricular volumes.
To assess whether characteristics of MRI after cardioversion can predict the rate of atrial fibrillation sinus rhythm maintenance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidate inpatients or outpatients will be identified if pharmacological or electrical cardioversion has be performed and LGE-MRI were performed after cardioversion at least twice.
Key inclusion criteria (4 listed)
- Patients carry a diagnosis of Persistent Atrial Fibrillation
- Patients have given informed consent
- Pharmacological or electrical cardioversion has be performed successfully
- late gadolinium enhanced magnetic resonance imaging (LGE-MRI) were performed after cardioversion at least twice
Key exclusion criteria (3 listed)
- Prior radiofrequency ablation treatment for atrial fibrillation
- Prior cardiac surgical procedures
- Individuals with cognitive impairments who are unable to give informed consent
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 |
|---|---|---|
| late gadolinium enhanced magnetic resonance imagingCandidate inpatients or outpatients will be identified if pharmacological or electrical cardioversion has be performed and MRI were performed after cardioversion at least twice. | Diagnostic test | – |
Primary outcome
The regression of left atrial fibrosis in patients with persist atrial fibrillation after cardioversion
Time frame: 3 to 6 months
The change in left atrial fibrosis (the core and border zone area, percentage of left atrium and segments involved) using MRI imaging, from baseline to the second measurement.
2 secondary outcomes
The effects of sinus rhythm in global parameters of myocardial remodeling
Time frame: 3 to 6 months
The effects of sinus rhythm in global parameters of myocardial remodeling
Time frame: 3 to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 10739903Thijssen VL, Ausma J, Liu GS, Allessie MA, van Eys GJ, Borgers M. Structural changes of atrial myocardium during chronic atrial fibrillation. Cardiovasc Pathol. 2000 Jan-Feb;9(1):17-28. doi: 10.1016/s1054-8807(99)00038-1.
- Background: PubMed 10715261Hobbs WJ, Fynn S, Todd DM, Wolfson P, Galloway M, Garratt CJ. Reversal of atrial electrical remodeling after cardioversion of persistent atrial fibrillation in humans. Circulation. 2000 Mar 14;101(10):1145-51. doi: 10.1161/01.cir.101.10.1145.
- Background: PubMed 24496537Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10.1001/jama.2014.3.
- Individual participant dataSharing planned: No
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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.
Yuehui Yin study director
The Second Affiliated Hospital of Chongqing Medical University
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 The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuehui Yin (+8613508335502, yinyh63@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The regression of left atrial fibrosis in patients with persist atrial fibrillation after cardioversion (time frame: 3 to 6 months). 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 NCT05099783, which also lists 3 linked publications.
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 28 Jul 2022.