BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction (BENEFIT-AMI)

Tongji University

Status: Enrolling

Conditions: Atrial Fibrillation New Onset; Acute Myocardial Infarction

Treatments: Device: Continuous Electronic Monitor

Study type: Observational

Funder types: Other

Identifiers

NCT04528511

BENEFIT-AMI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 774 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

774 participants in 2 patient groups

Low burden of new-onset atrial fibrillation

Description:

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.

Treatment:

Device: Continuous Electronic Monitor

High burden of new-onset atrial fibrillation

Description:

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.

Treatment:

Device: Continuous Electronic Monitor