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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Plaque Rupture Acute Coronary Syndrome Acute Coronary Syndromes Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Shanghai, 200333, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood is drawn to test for specific biomarkers

Diagnostic Test

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.

Primary outcomes

Specific biomarkers 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

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

Sponsors and collaborators

Lead sponsor

Xuebo Liu

Other

Registry information

Official study title

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

Acronym: NBPE-ACS

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2026
First posted: Jan 8, 2025
Registry last updated: Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed