New Onset Atrial FibrillationNOAFCAMI-ChinaNCT05511649
New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China
An observational study of New Onset Atrial Fibrillation and Acute Myocardial Infarction, run by Shanghai 10th People's Hospital at 3 sites in China.
Trial summary
To investigate the prognostic impacts of the atrial fibrillation burden (AFb) in acute myocardial infarction (AMI) patients who developed paroxysmal new-onset atrial fibrillation (NOAF) during the index AMI hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- New Onset Atrial Fibrillation, Acute Myocardial Infarction
- What is being tested?
- continuous electronic monitor
- Type of treatment
- Medical device
- How many people
- 832 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2023to 23 Sep 2023
- 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: Patients with post-MI NOAF
Who may be able to join
- Patients hospitalized for AMI including both STEMI and NSTEMI between January 2014 and January 2022 at the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University.
- Patients who developed a first documented AF (NOAF) during the index AMI hospitalization；
- Adult patients (>18 years old).
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' medical records with serious deficiencies and CEM data cannot be retrieved;
Trial locations and contacts
3 sites in 1 country.
China3 sites
KaiFeng Central Hospital
Kaifeng, Henan
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: The Prognostic Impacts and Clinical Utility of the Characteristics of New-onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China
To investigate the prognostic impacts of the atrial fibrillation burden (AFb) in acute myocardial infarction (AMI) patients who developed paroxysmal new-onset atrial fibrillation (NOAF) during the index AMI hospitalization.
Read the detailed description
In the present study, investigators retrospectively reviewed the medical records of all acute MI patients who were admitted to the coronary artery unit (CCU) of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University between January 2014 and January 2022. All patients will routinely receive continuous electronic monitoring (CEM) throughout their hospital stay to detect cardiac arrhythmias including the AF events. Of these, patients with AMI without a history of AF who developed a first documented AF episode will be considered for inclusion. The AFb is measured as a percentage (%) by dividing the total AF duration by the total CEM duration.
- Being tested
- continuous electronic monitor
- Keywords
- myocardial infarction, new-onset atrial fibrillation, atrial fibrillation burden, mortality
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous electronic monitorDevice
Also called Philips IntelliVue MP40, Netherlands
All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University will receive 24-hour continuous cardiac monitoring until discharge.
| Study group | Role | What they receive |
|---|---|---|
| Post-MI NOAF with low AF burden | Patients with post-MI NOAF who had a AF burden<10.87%. The cut-off value of AF burden of 10.87% was identified based on our previous work. Receives: Device: continuous electronic monitor | |
| Post-MI NOAF with high AF burden | Patients with post-MI NOAF who had a AF burden≥10.87%. 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: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Secondary outcomes (5)
Cardiovascular death
Death from cardiovascular causes
Measured: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Recurrent myocardial infarction
Rehospitalization for myocardial infarction
Measured: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Heart failure hospitalization
HF hospitalization was based on clinical symptoms such as dyspnea and fatigue, and signs of peripheral or pulmonary edema that required hospitalization for intravenous diuretic treatment
Measured: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Ischemic stroke
Ischemic stroke was identified as the presence of a new focal neurologic deficit thought to be ischemic in origin, with signs or symptoms lasting> 24 hours, and was validated according to radiographic imaging test.
Measured: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Major bleeding
Bleeding event with a Bleeding Academic Research Consortium (BARC) classification of types 3 or 5.
Measured: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Mar 2023
- Primary completion27 Jul 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for New Onset 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
- 832 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kaifeng Central Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yidong Wei, M.D., Ph.D., Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511649
- Sponsor's protocol ID
- NOAFCAMI-China
- Acronym
- NOAFCAMI-China
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Luo J, Qin X, Yuan Y, Zhang Y, Liu J, Wang Y, Zhao G, Xiao L, Zhang X, Fang Y, Shi W, Qin L, Liu B, Wei Y; NOAFCAMI-China Registry Investigators. Association of Atrial Fibrillation Burden With Cardiovascular Outcomes in New-Onset Atrial Fibrillation Complicating Myocardial Infarction. J Am Heart Assoc. 2025 May 20;14(10):e039547. doi: 10.1161/JAHA.124.039547. Epub 2025 Apr 16.
PubMed 40240944Luo J, Qin X, Fang Y, Zhang X, Zhang Y, Liu J, Wang Y, Zhao G, Xiao L, Shi W, Qin L, Liu B, Wei Y. Development and external validation of a prognostic model for new-onset atrial fibrillation complicating acute myocardial infarction: insights from the NOAFCAMI-China registry. Eur Heart J Acute Cardiovasc Care. 2026 Mar 10;15(1):32-41. doi: 10.1093/ehjacc/zuaf122.
PubMed 40974091
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
- The Prognostic Impacts and Clinical Utility of the Characteristics of New-onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China
- ClinicalTrials.gov ID
- NCT05511649
- Acronym / sponsor ID
- NOAFCAMI-China / NOAFCAMI-China
- Keywords
- myocardial infarction, new-onset atrial fibrillation, atrial fibrillation burden, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 832 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Kaifeng Central Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 23 Aug 2022 (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 investigate the prognostic impacts of the atrial fibrillation burden (AFb) in acute myocardial infarction (AMI) patients who developed paroxysmal new-onset atrial fibrillation (NOAF) during the index AMI hospitalization.
Detailed description
In the present study, investigators retrospectively reviewed the medical records of all acute MI patients who were admitted to the coronary artery unit (CCU) of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University between January 2014 and January 2022. All patients will routinely receive continuous electronic monitoring (CEM) throughout their hospital stay to detect cardiac arrhythmias including the AF events. Of these, patients with AMI without a history of AF who developed a first documented AF episode will be considered for inclusion. The AFb is measured as a percentage (%) by dividing the total AF duration by the total CEM duration.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-MI NOAF with low AF burden | – | Device: continuous electronic monitorPatients with post-MI NOAF who had a AF burden<10.87%. The cut-off value of AF burden of 10.87% was identified based on our previous work. |
| Post-MI NOAF with high AF burden | – | Device: continuous electronic monitorPatients with post-MI NOAF who had a AF burden≥10.87%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with post-MI NOAF
Key inclusion criteria (3 listed)
- Patients hospitalized for AMI including both STEMI and NSTEMI between January 2014 and January 2022 at the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University.
- Patients who developed a first documented AF (NOAF) during the index AMI hospitalization；
- Adult patients (>18 years old).
Key exclusion criteria (5 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' medical records with serious deficiencies and CEM data cannot be retrieved;
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 monitorAlso: Philips IntelliVue MP40, NetherlandsAll patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University will receive 24-hour continuous cardiac monitoring until discharge. | Device | Post-MI NOAF with high AF burden, Post-MI NOAF with low AF burden |
Primary outcome
All-cause death
Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Death from any cause
5 secondary outcomes
Cardiovascular death
Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Recurrent myocardial infarction
Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Heart failure hospitalization
Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Ischemic stroke
Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
Major bleeding
Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
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 19 Mar 2026.
- Results publication: PubMed 40240944Luo J, Qin X, Yuan Y, Zhang Y, Liu J, Wang Y, Zhao G, Xiao L, Zhang X, Fang Y, Shi W, Qin L, Liu B, Wei Y; NOAFCAMI-China Registry Investigators. Association of Atrial Fibrillation Burden With Cardiovascular Outcomes in New-Onset Atrial Fibrillation Complicating Myocardial Infarction. J Am Heart Assoc. 2025 May 20;14(10):e039547. doi: 10.1161/JAHA.124.039547. Epub 2025 Apr 16.
- Results publication: PubMed 40974091Luo J, Qin X, Fang Y, Zhang X, Zhang Y, Liu J, Wang Y, Zhao G, Xiao L, Shi W, Qin L, Liu B, Wei Y. Development and external validation of a prognostic model for new-onset atrial fibrillation complicating acute myocardial infarction: insights from the NOAFCAMI-China registry. Eur Heart J Acute Cardiovasc Care. 2026 Mar 10;15(1):32-41. doi: 10.1093/ehjacc/zuaf122.
- 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. This study is not recruiting at the moment.
Yidong Wei, M.D., Ph.D. principal investigator
Shanghai 10th People's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of New Onset Atrial Fibrillation and Acute Myocardial Infarction, run by Shanghai 10th People's Hospital at 3 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 3 inclusion and 5 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 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 3 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?
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?
All-cause death (time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years). 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 NCT05511649, which also lists 2 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 19 Mar 2026.