Prevalence, Clinical Features, and Prognosis of Coronary Artery Embolism with Concomitant Atrial Fibrillation

February 20, 2025 updated by: Jinsong Cheng，MD, First Affiliated Hospital of Ningbo University

The goal of this observational study is to learn about the Prevalence, Clinical Features, and Prognosis of Coronary Artery Embolism With Concomitant Atrial Fibrillation. The main question it aims to answer is:

What is the proportion of coronary artery embolism with concomitant atrial fibrillation among all myocardial infarctions and myocardial infarctions with concomitant atrial fibrillation? What are the clinical characteristics of coronary artery embolism with concomitant atrial fibrillation? What is the prognosis of coronary artery embolism with concomitant atrial fibrillation? All participants will receive routine diagnosis and treatment, and baseline demographic data, clinical examination laboratory results, and follow-up data will be collected for analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is designed as an observational study without involving experimental drugs or device interventions, only collecting data from routine medical practice.

Importance: Atrial fibrillation (AF) and acute myocardial infarction (AMI) share common risk factors and interact pathophysiologically. Coronary embolism (CE) is a critical mechanism of AMI in AF patients, yet its clinical features and prognosis remain understudied.

Objective: To investigate the incidence, clinical characteristics, and prognosis of CE in patients with AF.

Design, Setting, and Participants: A single-center retrospective case-control study was conducted at the Affiliated First Hospital of Ningbo University, China. Patients diagnosed with AMI who underwent coronary angiography (CAG) between January 1, 2014, and December 31, 2023, were included. CE was diagnosed using the Shibata criteria. Participants were categorized into three groups: AF-related CE, non-CE AF with AMI, and AMI without AF.

Main Outcomes and Measures: Baseline characteristics, clinical features, coronary involvement, treatment strategies, and outcomes (all-cause mortality, cardiac-death mortality, major adverse cardiovascular and cerebrovascular events [MACCE], recurrent embolism, and major bleeding) were compared.

Study Type

Observational

Enrollment (Actual)

5163

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
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • The First Affiliated Hospital of Ningbo University
      • Ningbo, Zhejiang, China
        • First Affiliated Hospital of Ningbo University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with acute myocardial infarction, with a history of atrial fibrillation or presenting with atrial fibrillation upon admission, who have undergone selective coronary angiography confirming typical thromboembolic events, with imaging studies identifying the thrombus origin from the left atrial appendage, with or without associated systemic embolism.

Description

Inclusion Criteria:

  • Clinical diagnosis of Acute myocardial infarction
  • Selective coronary angiography has been performed.

Exclusion Criteria:

  • Clinical diagnosis of Iatrogenic coronary artery embolism
  • Clinical diagnosis of Coronary artery dilation
  • Clinical diagnosis of Coronary in-stent thrombosis and embolism
  • Clinical diagnosis of Coronary slow flow syndrome
  • Clinical diagnosis of Coronary artery dissection
  • Clinical diagnosis of Coronary artery spasm
  • Pathological examination showed that the embolus contained atherosclerotic plaque
  • Endovascular imaging examinations, including intravascular ultrasound (IVUS) and optical coherence tomography (OCT), indicate the presence of plaque rupture, erosion, or ulceration in the culprit vessel.
  • Clinical diagnosis of Previous myocardial infarction
  • Previous coronary stent implantation or coronary artery bypass surgery.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
coronary artery embolism with concomitant atrial fibrillation
myocardial infarction patients who were coronary artery embolism with concomitant atrial fibrillation
Non-CE myocardial infarction with concomitant atrial fibrillation
myocardial infarction with concomitant atrial fibrillation(Non-coronary artery embolism )
myocardial infarction without concomitant atrial fibrillation
myocardial infarction without concomitant atrial fibrillation without coronary artery embolism
Other: Is it coronary artery embolism

This observational study categorizes patients with acute myocardial infarction (AMI) into three distinct groups based on their clinical characteristics:

  1. Group 1: Patients with atrial fibrillation (AF) and coronary artery embolism (CAE).
  2. Group 2: Patients with AF but non-coronary artery embolism myocardial infarction (non-CAE MI).
  3. Group 3: Patients without AF and non-coronary artery embolism myocardial infarction (non-CAE MI without AF).

A key innovation of this study compared to previous research is its expanded eligibility criteria for AMI patients. Earlier studies typically focused exclusively on ST-segment elevation myocardial infarction (STEMI). In contrast, this investigation encompasses a broader spectrum of acute myocardial infarction, including both STEMI and non-ST-segment elevation myocardial infarction (NSTEMI). This comprehensive approach enhances the generalizability and applicability of the findings by capturing a wider range of clinical scenarios.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death, cardiogenic death
Time Frame: Up to 10 years
Up to 10 years
Major Adverse Cardiovascular and Cerebrovascular Events
Time Frame: Up to 10 years
Up to 10 years
Systemic thrombo-embolism
Time Frame: Up to 10 years
Brain embolism, lower extremity arterial embolism, mesenteric arterial embolism, coronary artery embolism, splenic embolism, renal embolism.
Up to 10 years
Major hemorrhage
Time Frame: Up to 10 years
BARC Grades 3-5 Bleeding
Up to 10 years

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Ningbo University

Investigators

  • Study Director: CUI H bin, Doctor, Key research and development project of Zhejiang Province,Ningbo Clinical Research Center for Cardiovascular Disease

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)

May 1, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project No. 213RS, 2024
  • Grant No 2022L001 (Other Grant/Funding Number: Ningbo Clinical Research Center for Cardiovascular Disease)
  • 2021C03096 (Other Grant/Funding Number: Key research and development project of Zhejiang Province, 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

product manufactured in and exported from the U.S.

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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