Atrial Fibrillation New OnsetBENEFIT-AMINCT04528511
BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction
An observational study of Atrial Fibrillation New Onset and Acute Myocardial Infarction, run by Shanghai 10th People's Hospital at 5 sites in China.
Trial summary
To validate the prognostic importance of the burden of new-onset atrial fibrillation (NOAF) complicating acute myocardial infarction (AMI) in a prospectively designed hospital-based registry. To characterize those factors that contribute to the progression of post-MI NOAF burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset, Acute Myocardial Infarction
- What is being tested?
- Continuous Electronic Monitor
- Type of treatment
- Medical device
- How many people
- 774 participants
- Where
- 5 sitesChina
- Study dates
- 1 Oct 2020to 30 Jun 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with AMI who do not have a medical history of AF and develop an incident AF episode during the index hospitalization.
Who may be able to join
- Adult patients (>18 years old);
- Patient with AMI (including STEMI and NSTEMI) who developed NOAF during the index hospitalization;
- Patients must have received in-hospital CEM for at least 5 days;
- Patients must give informed consent.
Who cannot join
- Patients with a medical history of pre-existing AF;
- Patients with a medical history of rheumatic valvular disease;
- Patients with a medical history of sick sinus syndrome;
- Patients undergoing emergent coronary artery bypass surgery;
- Patients who suffer malignant tumors with an expected lifetime less than 1 year ;
- Patients who refuse to receive CEM during hospitalization and the data of heart rhythm cannot be retrieved;
- Patients who refuse to receive percutaneous coronary intervention (PCI) or have contraindications for PCI;
- Patients who have died during the index hospitalization.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Kaifeng Central Hospital
Kaifeng, Henan
Lei Qin, M.D.
- Recruiting
Luoyang Central Hospital
Luoyang, Henan
Xuewei Chang, M.D., Ph.D.
Xuewei Chang, M.D., Ph.D.
- Recruiting
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Jiachen Luo, M.D., Ph.D., +86-188-0179-0469, messichen@tongji.edu.cn
Yidong Wei, M.D., Ph.D.
- Recruiting
Shanghai Seventh People's Hospital
Shanghai, Shanghai Municipality
Shaowei Zhuang, M.D.
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Hongqiang Li, M.D., Ph.D.
About this study
Official title: BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction: the BENEFIT-AMI Multicenter Prospective Registry
To validate the prognostic importance of the burden of new-onset atrial fibrillation (NOAF) complicating acute myocardial infarction (AMI) in a prospectively designed hospital-based registry. To characterize those factors that contribute to the progression of post-MI NOAF burden. To establish a prediction model for the risk stratification of patients with NOAF complicating AMI. To explore the clinical usefulness of NOAF burden in guiding the anticoagulation therapy among patients with post-MI NOAF.
Read the detailed description
Our previously designed single-center retrospective cohort study (NCT03533543) suggested that patients with a greater burden of NOAF complicating AMI were challenged by a poor prognosis. In the present study, we aim to design a multicenter, prospective, hospital-based registry to validate the preceding findings. We plan to enroll patients who were admitted for AMI in 9 tertiary medical centers from Shanghai, Henan, and Zhejiang provinces and developed NOAF during the index hospitalization. All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, and medications will be collected. NOAF burden is calculated by dividing the total AF duration by the total continuous electronic monitoring (CEM) duration. Other NOAF related characteristics, such as AF pattern, AF frequency, and symptomatic or silent AF, and the longest AF episode duration will also be evaluated. All patients who are discharged alive will be followed for at least 2 years and cardiovascular outcomes will be recorded.
- Being tested
- Continuous Electronic Monitor
- Keywords
- Acute Myocardial Infarction, New-Onset Atrial Fibrillation, Burden, Prospective, Cardiovascular Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Electronic MonitorDevice
All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden
| Study group | Role | What they receive |
|---|---|---|
| Low burden of new-onset atrial fibrillation | Patients with MI who are free from a medical history of atrial fibrillation (AF) will be recognized as NOAF if they develop an atrial fibrillation (lasting for at least 30 seconds which are recorded by CEM) incident during hospitalization. Among this subset of patients, those who have a NOAF burden value<10.87% (previously established) will be divided into the low burden group. Receives: Device: Continuous Electronic Monitor | |
| High burden of new-onset atrial fibrillation | For patients with NOAF complicating AMI, those who have a NOAF burden value≥10.87% (previously established) will be divided into the high burden group. Receives: Device: Continuous Electronic Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Death from any cause
Measured: up to 1 year
Secondary outcomes (5)
Cardiovascular death
All deaths without a clear non-cardiovascular cause would be classified as cardiovascular deaths
Measured: up to 1 year
Heart failure hospitalization
Heart failure hospitalization is defined as a minimum of an overnight hospital stay of a participant who presented with symptoms and signs of HF or received intravenous diuretics
Measured: up to 1 year
Recurrent myocardial infarction
Recurrent myocardial infarction is defined as the myocardial infarction episode that occurs after 28 days following the index AMI hospitalization.
Measured: up to 1 year
Ischemic stroke
Ischemic stroke is defined as the presence of a new focal neurologic deficit thought to be ischemic in origin, with signs or symptoms lasting>24h.
Measured: up to 1 year
Major bleeding
Bleeding event with a Bleeding Academic Research Consortium (BRAC) classification of types 3 or 5
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies 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
- Prospective
- Enrolment
- 774 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, Kaifeng Central Hospital, Shanghai 7th People's Hospital, The First Affiliated Hospital of Zhengzhou University, Luoyang Central Hospital
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yidong Wei, M.D., Ph.D., Principal investigator, Department of Cardiology, Shanghai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528511
- Sponsor's protocol ID
- BENEFIT-AMI
- Acronym
- BENEFIT-AMI
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2020
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction: the BENEFIT-AMI Multicenter Prospective Registry
- ClinicalTrials.gov ID
- NCT04528511
- Acronym / sponsor ID
- BENEFIT-AMI / BENEFIT-AMI
- Keywords
- Acute Myocardial Infarction, New-Onset Atrial Fibrillation, Burden, Prospective, Cardiovascular Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 774 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai Tong Ren Hospital, Kaifeng Central Hospital, Shanghai 7th People's Hospital, The First Affiliated Hospital of Zhengzhou University, Luoyang Central Hospital
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Aug 2020 (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.
To validate the prognostic importance of the burden of new-onset atrial fibrillation (NOAF) complicating acute myocardial infarction (AMI) in a prospectively designed hospital-based registry. To characterize those factors that contribute to the progression of post-MI NOAF burden. To establish a prediction model for the risk stratification of patients with NOAF complicating AMI. To explore the clinical usefulness of NOAF burden in guiding the anticoagulation therapy among patients with post-MI NOAF.
Detailed description
Our previously designed single-center retrospective cohort study (NCT03533543) suggested that patients with a greater burden of NOAF complicating AMI were challenged by a poor prognosis. In the present study, we aim to design a multicenter, prospective, hospital-based registry to validate the preceding findings. We plan to enroll patients who were admitted for AMI in 9 tertiary medical centers from Shanghai, Henan, and Zhejiang provinces and developed NOAF during the index hospitalization. All eligible patients' demographics, cardiovascular risk factors, comorbidities, laboratory tests, echocardiography data, angiography data, and medications will be collected. NOAF burden is calculated by dividing the total AF duration by the total continuous electronic monitoring (CEM) duration. Other NOAF related characteristics, such as AF pattern, AF frequency, and symptomatic or silent AF, and the longest AF episode duration will also be evaluated. All patients who are discharged alive will be followed for at least 2 years and cardiovascular outcomes will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low burden of new-onset atrial fibrillation | – | Device: Continuous Electronic MonitorPatients with MI who are free from a medical history of atrial fibrillation (AF) will be recognized as NOAF if they develop an atrial fibrillation (lasting for at least 30 seconds which are recorded by CEM) incident during hospitalization. Among this subset of patients, those who have a NOAF burden value<10.87% (previously established) will be divided into the low burden group. |
| High burden of new-onset atrial fibrillation | – | Device: Continuous Electronic MonitorFor patients with NOAF complicating AMI, those who have a NOAF burden value≥10.87% (previously established) will be divided into the high burden group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with AMI who do not have a medical history of AF and develop an incident AF episode during the index hospitalization.
Key inclusion criteria (4 listed)
- Adult patients (>18 years old);
- Patient with AMI (including STEMI and NSTEMI) who developed NOAF during the index hospitalization;
- Patients must have received in-hospital CEM for at least 5 days;
- Patients must give informed consent.
Key exclusion criteria (8 listed)
- Patients with a medical history of pre-existing AF;
- Patients with a medical history of rheumatic valvular disease;
- Patients with a medical history of sick sinus syndrome;
- Patients undergoing emergent coronary artery bypass surgery;
- Patients who suffer malignant tumors with an expected lifetime less than 1 year ;
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 |
|---|---|---|
| Continuous Electronic MonitorAll patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden | Device | High burden of new-onset atrial fibrillation, Low burden of new-onset atrial fibrillation |
Primary outcome
All-cause death
Time frame: up to 1 year
Death from any cause
5 secondary outcomes
Cardiovascular death
Time frame: up to 1 year
Heart failure hospitalization
Time frame: up to 1 year
Recurrent myocardial infarction
Time frame: up to 1 year
Ischemic stroke
Time frame: up to 1 year
Major bleeding
Time frame: up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Yidong Wei, M.D., Ph.D. principal investigator
Department of Cardiology, Shanghai Tenth People's Hospital
5 sites 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 New Onset and Acute Myocardial Infarction, run by Shanghai 10th People's Hospital at 5 sites 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 8 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiachen Luo, M.D., Ph.D. (+86-188-0179-0469, messichen@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.