Clinical trial NCT06845956: Prevalence, Clinical Features, and Prognosis of Coronary Artery Embolism With Concomitant Atrial Fibrillation
Official title: Prevalence, Clinical Features, and Prognosis of Coronary Artery Embolism With Concomitant Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Embolism
Acute Myocardial Infarction Type 2
Keywords: coronary artery ebolism
acute myocardial infarction
atrial fibrillation
Lead sponsor: First Affiliated Hospital of Ningbo University
Sponsor class: NETWORK
First posted: 2025-02-25
Enrollment: 5163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause death, cardiogenic death
timeFrame: Up to 10 years
measure: Major Adverse Cardiovascular and Cerebrovascular Events
timeFrame: Up to 10 years
measure: Systemic thrombo-embolism
timeFrame: Up to 10 years
measure: Major hemorrhage
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: The First affiliated Hospital of Ningbo University
state: Zhejiang
city: Ningbo
country: China
facility: First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
affiliation: Key research and development project of Zhejiang Province,Ningbo Clinical Research Center for Cardiovascular Disease
name: CUI H bin, Doctor
role: STUDY_DIRECTOR
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