Active, not recruitingNCT06763835NBPE-ACSUpdated Jan 14, 2025

Novel Serum Biomarkers for Identifying Plaque Erosion in ACS and Predicting Prognosis

An observational study in Plaque Rupture and Acute Coronary Syndromes, sponsored by Xuebo Liu. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Xuebo Liu · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 301
Ages: 18 Years to 85 Years
Sex: All

Study summary

The goal of this observational study is to find novel serum biomarkers for the accurate diagnosis of plaque erosion (PE) from acute coronary syndrome (ACS) and help predicting the prognosis of PE. The main question it aims to answer is

Whether novel serum biomarkers could facilitate the non-invasive diagnosis and prognosis prediction of PE ? Participants will be contacted at 1,2,5 year after the diagnosis of PE-ACS or other reasons of ACS.

Conditions studied

Plaque Rupture
Acute Coronary Syndromes

Browse trials for

Keywords

plaque erosion
plaque rupture
acute coronary syndrome

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 301 is below the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

This is the only study on the registry with Xuebo Liu as lead sponsor.

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

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

The population of individuals with suspected acute coronary syndrome seeking treatment at the Department of Cardiology, Tongji Hospital, Shanghai.

Inclusion criteria

people presenting with an acute coronary syndrome (ACS)-either non-ST-segment elevation myocardial infarction (NSTE-ACS); or ST-segment elevation myocardial infarction (STE-ACS), and subsequently underwent emergent coronary angiography followed by percutaneous coronary intervention (PCI). Culprit leisions were tested using optical coheren tomograpgy and pathological diagnosis(PE OR PR) were validated by 2 independent experienced core lab members.

Exclusion criteria

Exclusion Criteria:

patients younger than 18 years or older than 85 years
patients in cardiogenic shock
prior coronary artery bypass grafting,
patients with corornary stent thrombosis
patients with left main coronary disease
patients with congestive heart failure
patients with life-threatening arrhythmia
patients with thrombocytopenia patients with significant hepatic or renal impairment
patients with septicemia, leukopenia, active inflammatory or malignant disease
other factors compromising high-quality optical coherence tomography (OCT) imaging (e.g., severe vessel tortuosity or calcification, persistent no-reflow, lesions in distal segments, or an indeterminate culprit lesion)
Individuals unable to provide informed consent were also excluded.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 301 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

acute coronary syndrome casued by plaque erosion(PE-ACS)
acute coronary syndrome patients casued by plaque erosion as identified by invasive optical coherence tomography in catheter labs.(PE-ACS)
Diagnostic Test: Blood is drawn to test for specific biomarkers
acute coronary syndrome casued by plaque rupture(PR-ACS)
acute coronary syndrome patients casued by plaque rupture as identified by invasive optical coherence tomography in catheter labs.(PR-ACS)
Diagnostic Test: Blood is drawn to test for specific biomarkers

Interventions

Diagnostic testBlood is drawn to test for specific biomarkers
After identifying characteristic biomarkers that can distinguish between PE-ACS and PR-ACS, we draw blood from ACS patients for testing to assist in determining whether the ACS subtype is PE-ACS or PR-ACS.

What researchers measure

Primary outcomes

Specific biomarkers can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS.
Specific biomarkers(Methylation sites, mRNA etc,.) can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS.
Time frame: From enrollment to the end of the follow-up at 1,2,5 year

Study locations

1 site

Tongji Hospital, Tongj University School of Medicine, 200333, Shanghai ,China
Shanghai, 200333, China

References and documents

Publications

Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available. PubMed 22922416 ↗
Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available. PubMed 26320110 ↗
Johnson TW, Raber L, Di Mario C, Bourantas CV, Jia H, Mattesini A, Gonzalo N, de la Torre Hernandez JM, Prati F, Koskinas KC, Joner M, Radu MD, Erlinge D, Regar E, Kunadian V, Maehara A, Byrne RA, Capodanno D, Akasaka T, Wijns W, Mintz GS, Guagliumi G. Clinical use of intracoronary imaging. Part 2: acute coronary syndromes, ambiguous coronary angiography findings, and guiding interventional decision-making: an expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. EuroIntervention. 2019 Aug 29;15(5):434-451. doi: 10.4244/EIJY19M06_02. PubMed 31258132 ↗
Jia H, Dai J, Hou J, Xing L, Ma L, Liu H, Xu M, Yao Y, Hu S, Yamamoto E, Lee H, Zhang S, Yu B, Jang IK. Effective anti-thrombotic therapy without stenting: intravascular optical coherence tomography-based management in plaque erosion (the EROSION study). Eur Heart J. 2017 Mar 14;38(11):792-800. doi: 10.1093/eurheartj/ehw381. PubMed 27578806 ↗
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 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06763835
Lead sponsor: Xuebo Liu
Responsible party: Xuebo Liu (Medical Doctor, Shanghai Tongji Hospital, Tongji University School of Medicine) — Sponsor-investigator
First posted: Jan 8, 2025
Start date: Feb 1, 2023
Primary completion: Jul 30, 2024
Completion: Jul 30, 2026 (estimated)
Last update: Jan 14, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Acute Coronary Syndrome→

Start the discussion