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

Acute Myocardial Infarction Clinical Trial

— BENEFIT-AMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04528511
• Other study ID #: BENEFIT-AMI
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2023
• Source: Shanghai 10th People's Hospital
• Contact: Jiachen Luo, M.D., Ph.D.
• Phone: +86-188-0179-0469
• Email: messichen[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 774
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Atrial Fibrillation
• Atrial Fibrillation New Onset
• Infarction
• Myocardial Infarction

Intervention

Device:
• Continuous Electronic Monitor
All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden

Locations

Country	Name	City	State
China	Kaifeng Central Hospital	Kai Feng	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	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital	Kaifeng Central Hospital, Shanghai 7th People's Hospital, Shanghai Tong Ren Hospital, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death	Death from any cause	up to 1 year
Secondary	Cardiovascular death	All deaths without a clear non-cardiovascular cause would be classified as cardiovascular deaths	up to 1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Major bleeding	Bleeding event with a Bleeding Academic Research Consortium (BRAC) classification of types 3 or 5	up to 1 year