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Acute Coronary SyndromeNCT03479723

Identification of Predictors for Coronary Plaque Erosion in Patients With Acute Coronary Syndrome

An observational study of Acute Coronary Syndrome, run by Massachusetts General Hospital at 1 site in United States.

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The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites. The main goal of this study is to identify the predictors of plaque erosion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
How many people
1,793 participants
Where
1 siteUnited States
Study dates
1 Dec 2017to 1 Aug 2024
How long will I take part?
3 Years
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 diagnosis of ACS confirmed by OCT imaging of the culprit lesion.

Who may be able to join

  • Diagnosed with ACS upon admission to hospital, including patients with ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina pectoris (UAP).
  • Intra-vascular OCT imaging of culprit vessel.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites. The main goal of this study is to identify the predictors of plaque erosion.

Read the detailed description

Plaque erosion is reported to be responsible for about one third of patients with acute coronary syndrome (ACS). In the EROSION study, we reported that antithrombotic therapy without stenting achieved a reduction in thrombus volume greater than 50% in over 70% of patients diagnosed with ACS caused by plaque erosion. This result suggests that the conservative approach of anti-thrombotic therapy without stenting may be an option for patients diagnosed with ACS caused by plaque erosion, which may be the paradigm shift in treatment of ACS patients. However, at present, the only way to make an in vivo diagnosis of plaque erosion is intra-coronary optical coherence tomography (OCT). If we can identify clinical factors associated with plaque erosion, we may be able to narrow down a sub-population of patients with a higher likelihood of plaque erosion. This group of patients may be stabilized with pharmacologic therapy and avoid invasive procedures, thereby preventing related complications and reducing health care burden. However, specific demographic characteristics of the ACS patients with plaque erosion are not known. Our group has the world's largest dataset of patients with plaque erosion and several published reports on plaque erosion. However, the study population of each study is still small and unbalanced to identify the demographic characteristics associated with plaque erosion. Therefore, we propose to pool data from a large number of institutions around the world. This will provide an opportunity to identify factors associated with plaque erosion.

Medical subject headings
Acute Coronary Syndrome

What is being measured

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

  1. Cardiac death

    Measured: 3-year

Secondary outcomes (13)

  1. all cause death

    Measured: 3-year

  2. myocardial infarction

    Measured: 3-year

  3. stent thrombosis

    stent thrombosis was defined according to the Academic Research Consortium criteria

    Measured: 3-year

  4. any target lesion revascularization

    Any revascularization due to thrombosis or restenosis of the target lesion

    Measured: 3-year

  5. clinically driven target lesion revascularization

    target lesion revascularization performed because of ischemic symptoms, electrocardiographic changes at rest or positive stress test relists

    Measured: 3-year

  6. target-vessel revascularization

    Revascularization of any segment of the coronary artery containing the target lesion

    Measured: 3-year

  7. any repeat revascularization

    Measured: 3-year

  8. stroke

    Measured: 3-year

  9. device-oriented composite (cardiac death, target vessel MI, and TLR)

    Measured: 3-year

  10. bleeding complication

    Gusto and BARC definition

    Measured: 3-year

  11. patients-oriented composite (all cause death, MI, any repeat coronary revascularization)

    Measured: 3-year

  12. target vessel failure (TVF; cardiac death, MI, or ischemia-driven TVR)

    Measured: 3-year

  13. major adverse cardiac events (MACEs: cardiac death, MI, or ischemia-driven TLR)

    Measured: 3-year

Timeline

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

  1. First posted27 Mar 2018
  2. Study start1 Dec 2017
  3. Primary completion1 Dec 2019
  4. Study completion1 Aug 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 only
Time perspective
Other
Enrolment
1,793 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03479723
Sponsor's protocol ID
2017P000329
Status last verified
Dec 2025
First submitted
14 Mar 2018
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Scalamera R, Covani M, Andreaggi S, Kim S, Lee H, McNulty I, Benenati S, Niccoli G, Vergallo R, Porto I, Jang IK. Non-modifiable cardiovascular risk factors and coronary plaque characteristics in patients with acute coronary syndromes. Eur Heart J Cardiovasc Imaging. 2026 Mar 27;27(4):733-742. doi: 10.1093/ehjci/jeag023.

    PubMed 41589067

  • Suzuki K, Niida T, Yuki H, Kinoshita D, Fujimoto D, Lee H, McNulty I, Takano M, Nakamura S, Kakuta T, Mizuno K, Jang IK. Coronary Plaque Characteristics and Underlying Mechanism of Acute Coronary Syndromes in Different Age Groups of Patients With Diabetes. J Am Heart Assoc. 2023 Dec 5;12(23):e031474. doi: 10.1161/JAHA.123.031474. Epub 2023 Nov 28.

    PubMed 38014673

  • Seegers LM, Yeh DD, Wood MJ, Yonetsu T, Minami Y, Araki M, Nakajima A, Yuki H, Ako J, Soeda T, Kurihara O, Higuma T, Kimura S, Adriaenssens T, Nef HM, Lee H, McNulty I, Sugiyama T, Kakuta T, Jang IK. Cardiovascular Risk Factors and Culprit Plaque Characteristics in Women With Acute Coronary Syndromes. Am J Cardiol. 2023 Nov 15;207:13-20. doi: 10.1016/j.amjcard.2023.08.152. Epub 2023 Sep 16.

    PubMed 37722196

  • Yuki H, Kinoshita D, Suzuki K, Niida T, Nakajima A, Seegers LM, Vergallo R, Fracassi F, Russo M, Di Vito L, Bryniarski K, McNulty I, Lee H, Kakuta T, Nakamura S, Jang IK. Layered plaque and plaque volume in patients with acute coronary syndromes. J Thromb Thrombolysis. 2023 Apr;55(3):432-438. doi: 10.1007/s11239-023-02788-9. Epub 2023 Mar 4.

    PubMed 36869878

  • Seegers LM, Araki M, Nakajima A, Yonetsu T, Minami Y, Ako J, Soeda T, Kurihara O, Higuma T, Kimura S, Adriaenssens T, Nef HM, Lee H, McNulty I, Sugiyama T, Kakuta T, Jang IK. Sex Differences in Culprit Plaque Characteristics Among Different Age Groups in Patients With Acute Coronary Syndromes. Circ Cardiovasc Interv. 2022 Jun;15(6):e011612. doi: 10.1161/CIRCINTERVENTIONS.121.011612. Epub 2022 Jun 2.

    PubMed 35652353

  • Araki M, Yonetsu T, Kurihara O, Nakajima A, Lee H, Soeda T, Minami Y, Higuma T, Kimura S, Takano M, Yan BP, Adriaenssens T, Boeder NF, Nef HM, Kim CJ, McNulty I, Crea F, Kakuta T, Jang IK. Age and Phenotype of Patients With Plaque Erosion. J Am Heart Assoc. 2021 Oct 5;10(19):e020691. doi: 10.1161/JAHA.120.020691. Epub 2021 Sep 25.

    PubMed 34569250

  • Nakajima A, Subban V, Russo M, Bryniarski KL, Kurihara O, Araki M, Minami Y, Soeda T, Yonetsu T, Crea F, Takano M, Higuma T, Kakuta T, Adriaenssens T, Boeder NF, Nef HM, Raffel OC, McNulty I, Lee H, Nakamura S, Abdullakutty J, Mathew R, Sankardas MA, Jang IK. Coronary plaque and clinical characteristics of South Asian (Indian) patients with acute coronary syndromes: An optical coherence tomography study. Int J Cardiol. 2021 Nov 15;343:171-179. doi: 10.1016/j.ijcard.2021.08.048. Epub 2021 Sep 3.

    PubMed 34487786

  • Kurihara O, Takano M, Yamamoto E, Yonetsu T, Kakuta T, Soeda T, Yan BP, Crea F, Higuma T, Kimura S, Minami Y, Adriaenssens T, Boeder NF, Nef HM, Kim CJ, Thondapu V, Kim HO, Russo M, Sugiyama T, Fracassi F, Lee H, Mizuno K, Jang IK. Seasonal Variations in the Pathogenesis of Acute Coronary Syndromes. J Am Heart Assoc. 2020 Jul 7;9(13):e015579. doi: 10.1161/JAHA.119.015579. Epub 2020 Jul 2.

    PubMed 32611221

  • Yamamoto E, Yonetsu T, Kakuta T, Soeda T, Saito Y, Yan BP, Kurihara O, Takano M, Niccoli G, Higuma T, Kimura S, Minami Y, Ako J, Adriaenssens T, Boeder NF, Nef HM, Fracassi F, Sugiyama T, Lee H, Crea F, Kimura T, Fujimoto JG, Fuster V, Jang IK. Clinical and Laboratory Predictors for Plaque Erosion in Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2019 Nov 5;8(21):e012322. doi: 10.1161/JAHA.119.012322. Epub 2019 Oct 23.

    PubMed 31640466

  • Sugiyama T, Yamamoto E, Fracassi F, Lee H, Yonetsu T, Kakuta T, Soeda T, Saito Y, Yan BP, Kurihara O, Takano M, Niccoli G, Crea F, Higuma T, Kimura S, Minami Y, Ako J, Adriaenssens T, Boeder NF, Nef HM, Fujimoto JG, Fuster V, Finn AV, Falk E, Jang IK. Calcified Plaques in Patients With Acute Coronary Syndromes. JACC Cardiovasc Interv. 2019 Mar 25;12(6):531-540. doi: 10.1016/j.jcin.2018.12.013.

    PubMed 30898249

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome, run by Massachusetts General Hospital at 1 site in United States.

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 1 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Cardiac death (time frame: 3-year). 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 NCT03479723, 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 29 Dec 2025.

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