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NCT Number: NCT04528511

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaifeng Central Hospital, Kaifeng, Henan, China

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

continuous electronic monitor

Device

All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden

Primary outcomes

  1. All-cause death

    Time frame: up to 1 year

    Death from any cause

Secondary outcomes

  1. Cardiovascular death

    Time frame: up to 1 year

    All deaths without a clear non-cardiovascular cause would be classified as cardiovascular deaths

  2. Heart failure hospitalization

    Time frame: 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

  3. Recurrent myocardial infarction

    Time frame: up to 1 year

    Recurrent myocardial infarction is defined as the myocardial infarction episode that occurs after 28 days following the index AMI hospitalization.

  4. Ischemic stroke

    Time frame: 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.

  5. Major bleeding

    Time frame: up to 1 year

    Bleeding event with a Bleeding Academic Research Consortium (BRAC) classification of types 3 or 5

Study contacts

Contact information is provided by the study sponsor or research team.

Jiachen Luo, M.D., Ph.D.

CONTACT

[email protected]

+86-188-0179-0469

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Collaborators

  • Kaifeng Central Hospital
  • Luoyang Central Hospital
  • Shanghai 7th People's Hospital
  • Shanghai Tong Ren Hospital
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

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

Acronym: BENEFIT-AMI

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Aug 27, 2020
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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