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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myocardial Infarction; Atrial Fibrillation New Onset
• Intervention / Treatment: Device: Continuous Electronic Monitor

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.

• Study Type: Observational
• Enrollment (Estimated): 774

Contacts and Locations

• Study Contact: Name: Jiachen Luo, M.D., Ph.D.; Phone Number: +86-188-0179-0469; Email: messichen@tongji.edu.cn

Study Locations

• China
  • Henan
    • Kai Feng, Henan, China
      • Recruiting
      • Kaifeng Central Hospital
      • Principal Investigator: Lei Qin, M.D.
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Hongqiang Li, M.D., Ph.D.
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Department of Cardiology, Shanghai Tenth People's Hospital
      • Principal Investigator: Yidong Wei, M.D., Ph.D.
      • Contact: Jiachen Luo, M.D., Ph.D.; Phone Number: +86-188-0179-0469; Email: messichen@tongji.edu.cn
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Seventh People's Hospital
      • Principal Investigator: Shaowei Zhuang, M.D.
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Tong Ren Hospital
      • Principal Investigator: Lei Hou, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with AMI who do not have a medical history of AF and develop an incident AF episode during the index hospitalization.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low burden of new-onset atrial fibrillation; 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; All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden
High burden of new-onset atrial fibrillation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	Death from any cause	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	All deaths without a clear non-cardiovascular cause would be classified as cardiovascular deaths	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	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.	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.	up to 1 year
Major bleeding	Bleeding event with a Bleeding Academic Research Consortium (BRAC) classification of types 3 or 5	up to 1 year

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Collaborators: Shanghai Tong Ren Hospital; The First Affiliated Hospital of Zhengzhou University; Kaifeng Central Hospital; Shanghai 7th People's Hospital
• Investigators: Principal Investigator: Yidong Wei, M.D., Ph.D., Department of Cardiology, Shanghai Tenth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction; Burden; Prospective; New-Onset Atrial Fibrillation; Cardiovascular Outcomes
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Myocardial Infarction; Infarction; Atrial Fibrillation
• Other Study ID Numbers: BENEFIT-AMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No