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Coronary Artery EmbolismNCT06845956

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

An observational study of Coronary Artery Embolism and Acute Myocardial Infarction Type 2, run by First Affiliated Hospital of Ningbo University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Is it coronary artery embolism
How many people
5,163 participants
Where
2 sitesChina
Study dates
1 May 2024to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites
  • The First affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

  • First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

Other trials in China

About this study

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.

Being tested
Is it coronary artery embolism
Keywords
coronary artery ebolism, acute myocardial infarction, atrial fibrillation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Is it coronary artery embolismOther

    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.

Study groups in NCT06845956
Study groupRoleWhat they receive
coronary artery embolism with concomitant atrial fibrillationmyocardial infarction patients who were coronary artery embolism with concomitant atrial fibrillation
Non-CE myocardial infarction with concomitant atrial fibrillationmyocardial infarction with concomitant atrial fibrillation(Non-coronary artery embolism )
myocardial infarction without concomitant atrial fibrillationmyocardial infarction without concomitant atrial fibrillation without coronary artery embolism
Receives: Other: Is it coronary artery embolism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause death, cardiogenic death

    Measured: Up to 10 years

  2. Major Adverse Cardiovascular and Cerebrovascular Events

    Measured: Up to 10 years

  3. Systemic thrombo-embolism

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

    Measured: Up to 10 years

  4. Major hemorrhage

    BARC Grades 3-5 Bleeding

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start1 May 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
5,163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06845956
Sponsor's protocol ID
Project No. 213RS, 2024
Other IDs
Grant No 2022L001, 2021C03096
Status last verified
Feb 2025
First submitted
29 Nov 2024
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Embolism and Acute Myocardial Infarction Type 2, run by First Affiliated Hospital of Ningbo University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause death, cardiogenic death (time frame: Up to 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06845956, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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