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

NCT ID: NCT06845956

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

5163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Embolism Acute Myocardial Infarction Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

coronary artery embolism with concomitant atrial fibrillation

myocardial infarction patients who were coronary artery embolism with concomitant atrial fibrillation

No interventions assigned to this group

Non-CE myocardial infarction with concomitant atrial fibrillation

myocardial infarction with concomitant atrial fibrillation(Non-coronary artery embolism )

No interventions assigned to this group

myocardial infarction without concomitant atrial fibrillation

myocardial infarction without concomitant atrial fibrillation without coronary artery embolism

Is it coronary artery embolism

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jinsong Cheng,MD

Doctor of medicine, Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

CUI H bin, Doctor

Role: STUDY_DIRECTOR

Key research and development project of Zhejiang Province,Ningbo Clinical Research Center for Cardiovascular Disease

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Site Status

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Tsao CW, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Beaton AZ, Boehme AK, Buxton AE, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Fugar S, Generoso G, Heard DG, Hiremath S, Ho JE, Kalani R, Kazi DS, Ko D, Levine DA, Liu J, Ma J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Virani SS, Voeks JH, Wang NY, Wong ND, Wong SS, Yaffe K, Martin SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2023 Update: A Report From the American Heart Association. Circulation. 2023 Feb 21;147(8):e93-e621. doi: 10.1161/CIR.0000000000001123. Epub 2023 Jan 25.

Reference Type BACKGROUND
PMID: 36695182 (View on PubMed)

Shibata T, Kawakami S, Noguchi T, Tanaka T, Asaumi Y, Kanaya T, Nagai T, Nakao K, Fujino M, Nagatsuka K, Ishibashi-Ueda H, Nishimura K, Miyamoto Y, Kusano K, Anzai T, Goto Y, Ogawa H, Yasuda S. Prevalence, Clinical Features, and Prognosis of Acute Myocardial Infarction Attributable to Coronary Artery Embolism. Circulation. 2015 Jul 28;132(4):241-50. doi: 10.1161/CIRCULATIONAHA.114.015134. Epub 2015 Jun 25.

Reference Type BACKGROUND
PMID: 26216084 (View on PubMed)

Menke J, Luthje L, Kastrup A, Larsen J. Thromboembolism in atrial fibrillation. Am J Cardiol. 2010 Feb 15;105(4):502-10. doi: 10.1016/j.amjcard.2009.10.018.

Reference Type BACKGROUND
PMID: 20152245 (View on PubMed)

Popovic B, Varlot J, Humbertjean L, Sellal JM, Pace N, Hammache N, Fay R, Eggenspieler F, Metzdorf PA, Camenzind E. Coronary Embolism Among Patients With ST-Segment-Elevation Myocardial Infarction and Atrial Fibrillation: An Underrecognized But Deadly Association. J Am Heart Assoc. 2024 May 21;13(10):e032199. doi: 10.1161/JAHA.123.032199. Epub 2024 May 14.

Reference Type BACKGROUND
PMID: 38742522 (View on PubMed)

Jia H, Abtahian F, Aguirre AD, Lee S, Chia S, Lowe H, Kato K, Yonetsu T, Vergallo R, Hu S, Tian J, Lee H, Park SJ, Jang YS, Raffel OC, Mizuno K, Uemura S, Itoh T, Kakuta T, Choi SY, Dauerman HL, Prasad A, Toma C, McNulty I, Zhang S, Yu B, Fuster V, Narula J, Virmani R, Jang IK. In vivo diagnosis of plaque erosion and calcified nodule in patients with acute coronary syndrome by intravascular optical coherence tomography. J Am Coll Cardiol. 2013 Nov 5;62(19):1748-58. doi: 10.1016/j.jacc.2013.05.071. Epub 2013 Jun 27.

Reference Type BACKGROUND
PMID: 23810884 (View on PubMed)

Frederiksen TC, Dahm CC, Preis SR, Lin H, Trinquart L, Benjamin EJ, Kornej J. The bidirectional association between atrial fibrillation and myocardial infarction. Nat Rev Cardiol. 2023 Sep;20(9):631-644. doi: 10.1038/s41569-023-00857-3. Epub 2023 Apr 17.

Reference Type BACKGROUND
PMID: 37069297 (View on PubMed)

Obayashi Y, Shiomi H, Morimoto T, Tamaki Y, Inoko M, Yamamoto K, Takeji Y, Tada T, Nagao K, Yamaji K, Kaneda K, Suwa S, Tamura T, Sakamoto H, Inada T, Matsuda M, Sato Y, Furukawa Y, Ando K, Kadota K, Nakagawa Y, Kimura T; CREDO-Kyoto AMI Registry Wave-2 Investigators. Newly Diagnosed Atrial Fibrillation in Acute Myocardial Infarction. J Am Heart Assoc. 2021 Sep 21;10(18):e021417. doi: 10.1161/JAHA.121.021417. Epub 2021 Sep 17.

Reference Type BACKGROUND
PMID: 34533047 (View on PubMed)

Lee JH, Kim SH, Lee W, Cho Y, Kang SH, Park JJ, Oh IY, Yoon CH, Suh JW, Cho YS, Youn TJ, Chae IH, Choi DJ. New-onset paroxysmal atrial fibrillation in acute myocardial infarction: increased risk of stroke. BMJ Open. 2020 Sep 23;10(9):e039600. doi: 10.1136/bmjopen-2020-039600.

Reference Type BACKGROUND
PMID: 32967885 (View on PubMed)

Vaduganathan M, Mensah GA, Turco JV, Fuster V, Roth GA. The Global Burden of Cardiovascular Diseases and Risk: A Compass for Future Health. J Am Coll Cardiol. 2022 Dec 20;80(25):2361-2371. doi: 10.1016/j.jacc.2022.11.005. Epub 2022 Nov 9. No abstract available.

Reference Type BACKGROUND
PMID: 36368511 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Grant No 2022L001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021C03096

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Project No. 213RS, 2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Myocardial Infarction Prediction
NCT01870258 COMPLETED NA