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Clinical Trials/NCT06845956
NCT06845956CompletedNot Applicable

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

First Affiliated Hospital of Ningbo University2 sites in 1 country5,163 target enrollmentStarted: May 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
5,163
Locations
2
Primary Endpoint
All-cause death, cardiogenic death

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

All-cause death, cardiogenic death

Time Frame: Up to 10 years

Major Adverse Cardiovascular and Cerebrovascular Events

Time Frame: 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.

Major hemorrhage

Time Frame: Up to 10 years

BARC Grades 3-5 Bleeding

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
First Affiliated Hospital of Ningbo University
Sponsor Class
Network
Responsible Party
Principal Investigator
Principal Investigator

Jinsong Cheng,MD

Doctor of medicine, Chief physician

First Affiliated Hospital of Ningbo University

Study Sites (2)

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