BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Electronic Monitor.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation New Onset, Acute Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BurdEn of NEw Onset Atrial FIbrillation in patienTs With Acute Myocardial Infarction: the BENEFIT-AMI Multicenter Prospective Registry
Overview
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.
Interventions
- Device Continuous Electronic Monitor
All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden
Primary outcome measures
- All-cause death [Time frame: up to 1 year]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 5 centers
- Kaifeng Central Hospital — Kaifeng
- Luoyang Central Hospital — Luoyang
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
- Department of Cardiology, Shanghai Tenth People's Hospital — Shanghai
- Shanghai Seventh People's Hospital — Shanghai
Identifiers
NCT: NCT04528511 · BENEFIT-AMI