NCT04528511

BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction

BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction: the BENEFIT-AMI Multicenter Prospective Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 774 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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. 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.

Conditions

• Atrial Fibrillation New Onset
• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Continuous Electronic Monitor	All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden

Timeline

• Start date: 2020-10-01
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2020-08-27
• Last updated: 2026-03-19

Locations

5 sites across 1 country: China