New-Onset Atrial Fibrillation Complicating Acute Myocardial Infarction in China (NOAFCAMI-China)

March 16, 2026 updated by: Ya-Wei Xu, Shanghai 10th People's Hospital

The Prognostic Impacts and Clinical Utility of the Characteristics of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

832

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Kaifeng, Henan, China
        • Kaifeng Central Hospital
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200072
        • Shanghai Tenth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with post-MI NOAF

Description

Inclusion Criteria:

  1. 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.
  2. Patients who developed a first documented AF (NOAF) during the index AMI hospitalization；
  3. Adult patients (>18 years old).

Exclusion Criteria:

  1. Patients with a medical history of pre-existing AF;
  2. Patients with a medical history of rheumatic valvular disease;
  3. Patients with a medical history of sick sinus syndrome;
  4. Patients undergoing emergent coronary artery bypass surgery;
  5. Patients' medical records with serious deficiencies and CEM data cannot be retrieved;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-MI NOAF with low AF burden
Patients with post-MI NOAF who had a AF burden<10.87%. The cut-off value of AF burden of 10.87% was identified based on our previous work.
Device: continuous electronic monitor
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
Post-MI NOAF with high AF burden
Patients with post-MI NOAF who had a AF burden≥10.87%.
Device: continuous electronic monitor
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
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
From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
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
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
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.
From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years
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.
From the time of AMI discharge until occurrence of an outcome of interest, death, or loss to follow up, maximum up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Collaborators

The First Affiliated Hospital of Zhengzhou University
Kaifeng Central Hospital

Investigators

  • Principal Investigator: Yidong Wei, M.D., Ph.D., Shanghai 10th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

July 27, 2023

Study Completion (Actual)

September 23, 2023

Study Registration Dates

First Submitted

August 20, 2022

First Submitted That Met QC Criteria

August 20, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOAFCAMI-China

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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