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Clinical Trials/NCT06763835
NCT06763835
Active, not recruiting
Not Applicable

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

Xuebo Liu1 site in 1 country301 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Plaque Rupture
Sponsor
Xuebo Liu
Enrollment
301
Locations
1
Primary Endpoint
Specific biomarkers can serve as diagnostic and prognostic indicators for subclassifying PE-ACS or PR-ACS.
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
July 30, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Xuebo Liu
Responsible Party
Sponsor Investigator
Principal Investigator

Xuebo Liu

Medical Doctor

Shanghai Tongji Hospital, Tongji University School of Medicine

Eligibility Criteria

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)

Outcomes

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.

Study Sites (1)

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