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

Development and Validation of Diagnostic and Prognostic Model of Acute Coronary Syndrome Caused by Plaque Erosion Using Novel Serum Biomarkers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06763835
Acronym
NBPE-ACS
Enrollment
301
Registered
2025-01-08
Start date
2023-02-01
Completion date
2026-07-30
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndromes, Plaque Rupture

Keywords

plaque erosion, plaque rupture, acute coronary syndrome

Brief 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.

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.

Sponsors

Xuebo Liu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

* 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.

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026