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

Recruiting

• Conditions: Atrial Fibrillation New Onset; Acute Myocardial Infarction
• Interventions: Device: Continuous Electronic Monitor

• Registration Number: NCT04528511
• Lead Sponsor: Shanghai 10th People's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-27
• Study Start: 2020-10-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 774

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High burden of new-onset atrial fibrillation	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.
Low burden of new-onset atrial fibrillation	Continuous Electronic Monitor	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.

Primary Outcome Measures

Name	Time	Method
All-cause death	up to 1 year	Death from any cause

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	up to 1 year	All deaths without a clear non-cardiovascular cause would be classified as cardiovascular deaths
Heart failure hospitalization	up to 1 year	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
Ischemic stroke	up to 1 year	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.
Recurrent myocardial infarction	up to 1 year	Recurrent myocardial infarction is defined as the myocardial infarction episode that occurs after 28 days following the index AMI hospitalization.
Major bleeding	up to 1 year	Bleeding event with a Bleeding Academic Research Consortium (BRAC) classification of types 3 or 5

Trial Locations

Locations (5)

Kaifeng Central Hospital; 🇨🇳 Kai Feng, Henan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Department of Cardiology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Seventh People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Tong Ren Hospital; 🇨🇳 Shanghai, Shanghai, China