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CompletedNCT06845956Updated Feb 25, 2025

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

An observational study in Coronary Artery Embolism and Acute Myocardial Infarction Type 2, sponsored by First Affiliated Hospital of Ningbo University. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by First Affiliated Hospital of Ningbo University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
5,163
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Embolism
  • Acute Myocardial Infarction Type 2

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Keywords

  • coronary artery ebolism
  • acute myocardial infarction
  • atrial fibrillation
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 5,163 is above the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

First Affiliated Hospital of Ningbo University is the lead sponsor of 27 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
5,163 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherIs 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.

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What researchers measure

Primary outcomes

  1. All-cause death, cardiogenic death

    Time frame: Up to 10 years

  2. Major Adverse Cardiovascular and Cerebrovascular Events

    Time frame: Up to 10 years

  3. Systemic thrombo-embolism

    Brain embolism, lower extremity arterial embolism, mesenteric arterial embolism, coronary artery embolism, splenic embolism, renal embolism.

    Time frame: Up to 10 years

  4. Major hemorrhage

    BARC Grades 3-5 Bleeding

    Time frame: Up to 10 years

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Study locations

2 sites
  • The First affiliated Hospital of Ningbo University
    Ningbo, Zhejiang 315010, China
  • First Affiliated Hospital of Ningbo University
    Ningbo, Zhejiang, China
08

References and documents

Publications

  • 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. PubMed 36695182 ↗
  • 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. PubMed 26216084 ↗
  • 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. PubMed 20152245 ↗
  • 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. PubMed 38742522 ↗
  • 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. PubMed 23810884 ↗
  • 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. PubMed 37069297 ↗
  • 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. PubMed 34533047 ↗
  • 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. PubMed 32967885 ↗
  • 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. PubMed 36368511 ↗
  • Cheng J, Mao H MCM, Guan M, Cui H. Coronary Embolism in Atrial Fibrillation: A Distinct High-Risk Phenotype With Residual Thromboembolic Risk Despite Anticoagulation. J Am Heart Assoc. 2026 May 5;15(9):e045749. doi: 10.1161/JAHA.125.045749. Epub 2026 Apr 29. PubMed 42052982 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06845956
Lead sponsor
First Affiliated Hospital of Ningbo University
Responsible party
Jinsong Cheng,MD (Doctor of medicine, Chief physician, First Affiliated Hospital of Ningbo University) — Principal investigator
First posted
Feb 25, 2025
Start date
May 1, 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Feb 25, 2025

Study contacts

CUI H bin, Doctor
study director · Key research and development project of Zhejiang Province,Ningbo Clinical Research Center for Cardiovascular Disease

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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