Novel Serum Biomarkers for Identifying Plaque Erosion in ACS and Predicting Prognosis (NBPE-ACS)

January 13, 2025 updated by: Xuebo Liu

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

301

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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
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 is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the follow-up at 1,2,5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuebo Liu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

July 30, 2024

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJH-2023-010
  • ITJ(QN)2203 (Other Grant/Funding Number: Clinical Research Project of Tongji Hospital of Tongji University)
  • 18411950300 (Other Grant/Funding Number: Shanghai Science and Technology Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndromes

Clinical Trials on Blood is drawn to test for specific biomarkers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe