An observational study in Atrial Fibrillation New Onset and Acute Myocardial Infarction, sponsored by Shanghai 10th People's Hospital. Recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Shanghai 10th People's Hospital · Observational
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.
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.
Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with AMI who do not have a medical history of AF and develop an incident AF episode during the index hospitalization.
Exclusion Criteria:
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.
Device: Continuous Electronic Monitor
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.
Device: Continuous Electronic Monitor
All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden
All-cause death
Death from any cause
Time frame: up to 1 year
Cardiovascular death
All deaths without a clear non-cardiovascular cause would be classified as cardiovascular deaths
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: up to 1 year
Major bleeding
Bleeding event with a Bleeding Academic Research Consortium (BRAC) classification of types 3 or 5
Time frame: up to 1 year
Plan to share: Undecided
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Shanghai 10th People's Hospital