NCT03479723

Brief 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The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,793

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

March 14, 2018

Last Update Submit

December 22, 2025

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Cardiac death

    3-year

Secondary Outcomes (13)

  • all cause death

    3-year

  • myocardial infarction

    3-year

  • stent thrombosis

    3-year

  • any target lesion revascularization

    3-year

  • clinically driven target lesion revascularization

    3-year

  • +8 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diagnosis of ACS confirmed by OCT imaging of the culprit lesion.

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (10)

  • 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.

    PMID: 41589067DERIVED

  • 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.

    PMID: 38014673DERIVED

  • 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.

    PMID: 37722196DERIVED

  • 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.

    PMID: 36869878DERIVED

  • 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.

    PMID: 35652353DERIVED

  • 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.

    PMID: 34569250DERIVED

  • 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.

    PMID: 34487786DERIVED

  • 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.

    PMID: 32611221DERIVED

  • 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.

    PMID: 31640466DERIVED

  • 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.

    PMID: 30898249DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Ik-Kyung Jang, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine; Director, Cardiology Laboratory for Integrative Physiology & Imaging

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 27, 2018

Study Start

December 1, 2017

Primary Completion

December 1, 2019

Study Completion

August 1, 2024

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations

US(1)