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

Active, not recruiting

• Conditions: Plaque Rupture; Acute Coronary Syndromes

• Registration Number: NCT06763835
• Lead Sponsor: Xuebo Liu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2024-07-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 301

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 year	Specific biomarkers(Methylation sites, mRNA etc,.) can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS.

Trial Locations

Locations (1)

Tongji Hospital, Tongj University School of Medicine, 200333, Shanghai ,China; 🇨🇳 Shanghai, China