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Completed

NCT Number: NCT05511649

New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China

To investigate the prognostic impacts of the atrial fibrillation burden (AFb) in acute myocardial infarction (AMI) patients who developed paroxysmal new-onset atrial fibrillation (NOAF) during the index AMI hospitalization.

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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

In the present study, investigators retrospectively reviewed the medical records of all acute MI patients who were admitted to the coronary artery unit (CCU) of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University between January 2014 and January 2022. All patients will routinely receive continuous electronic monitoring (CEM) throughout their hospital stay to detect cardiac arrhythmias including the AF events. Of these, patients with AMI without a history of AF who developed a first documented AF episode will be considered for inclusion. The AFb is measured as a percentage (%) by dividing the total AF duration by the total CEM duration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients hospitalized for AMI including both STEMI and NSTEMI between January 2014 and January 2022 at the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University.
  • Patients who developed a first documented AF (NOAF) during the index AMI hospitalization;
  • Adult patients (>18 years old).

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' medical records with serious deficiencies and CEM data cannot be retrieved;

Treatment and study plan

continuous electronic monitor

Device

All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital, KaiFeng Central Hospital, and the First Affiliated Hospital of Zhengzhou University will receive 24-hour continuous cardiac monitoring until discharge.

Other names: Philips IntelliVue MP40, Netherlands

Primary outcomes

  1. All-cause death

    Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

    Death from any cause

Secondary outcomes

  1. Cardiovascular death

    Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

    Death from cardiovascular causes

  2. Recurrent myocardial infarction

    Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

    Rehospitalization for myocardial infarction

  3. Heart failure hospitalization

    Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

    HF hospitalization was based on clinical symptoms such as dyspnea and fatigue, and signs of peripheral or pulmonary edema that required hospitalization for intravenous diuretic treatment

  4. Ischemic stroke

    Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

    Ischemic stroke was identified as the presence of a new focal neurologic deficit thought to be ischemic in origin, with signs or symptoms lasting> 24 hours, and was validated according to radiographic imaging test.

  5. Major bleeding

    Time frame: From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

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

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Collaborators

  • Kaifeng Central Hospital
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

The Prognostic Impacts and Clinical Utility of the Characteristics of New-onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China

Acronym: NOAFCAMI-China

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2022
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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