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NCT Number: NCT06955143

A Study on the Peripheral Blood in Patients With Acute Coronary Syndrome

The goal of this study is to conduct analyses the changes of cell growth factors, inflammatory factors, metabolites, plasma proteome, etc. in the blood of patients with ACS (acute coronary syndrome), as well as their correlations with the disease prognosis, based on multi-omics or other related research methods. The main questions it aims to answer are:

The growth factors that have significant changes in the peripheral blood of the ACS population, especially fibroblast growth factors? Inflammatory factors and chemokines related to the onset of ACS? The metabolites and proteins that are significantly altered in the peripheral blood after the onset of ACS? Researchers will compare ACS population to CCS (Chronic Coronary Syndrome) population, and control group (patients without coronary artery stenosis, valvular heart disease, structural heart disease, or any other kind of cardiomyopathy).The peripheral venous blood from the participants will be collected within 24 hours after their admission to the hospital.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Chronic Coronary Syndrome Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lishui Central Hospital

Lishui, Zhejiang, China

Location status: Recruiting

Location contact

Jiayi Shen

CONTACT

[email protected]

86+15990735525

Who can participate

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

Inclusion criteria

For ACS group STEMI

  • cTn>99th ULN or CK-MB>99th ULN
  • ST-segment elevation with a convex upward morphology
  • in conjunction with one or more of the following conditions: persistent ischemic chest pain; echocardiographic evidence of abnormal segmental ventricular wall motion; or abnormal coronary angiography findings.

NSTEMI

  • cTn>99th ULN or CK-MB>99th ULN
  • accompanied by one or more of the following situations: persistent ischemic chest pain; new ST-segment depression or low and inverted T waves; echocardiography showing segmental ventricular wall motion abnormalities; abnormal coronary angiography.

UA

  • cTn normal
  • ischemic chest pain with an electrocardiogram showing transient ST-segment depression or flattened and inverted T waves
  • evidence of coronary artery stenosis (e.g., CTA demonstrating ≥ 50% stenosis) For CCS group
  • Clinical Diagnosis Consistent with CCS Categories, meet any one of the following clinical scenarios: Stable Angina Pectoris, Ischemic Cardiomyopathy, Post-ACS Stable Phase, Long-Term CAD Management, Vasospastic or Microvascular Disease, Asymptomatic CAD
  • Laboratory and Imaging Confirmation: Resting ECG without ST-segment elevation or dynamic changes (excluding ACS), cTn normal or stable (no acute myocardial injury), ≥50% luminal stenosis in ≥1 epicardial coronary artery For control group
  • Patients without coronary artery stenosis, valvular heart disease, structural heart disease, or any other kind of cardiomyopathy

Exclusion criteria

  • Lactating or pregnant women
  • Patients with malignant neoplasms
  • Severe hepatic/renal dysfunction
  • Severe hematological disorders
  • Autoimmune diseases

Treatment and study plan

Primary outcomes

  1. circulating fibroblast growth factors (FGFs) levels

    Time frame: within 24 hours of admission to the hospital

    examining the circulating fibroblast growth factors levels in the peripheral venous blood of the participants

  2. circulating inflammatory cytokines levels

    Time frame: within 24 hours of admission to the hospital

    examining the circulating inflammatory cytokines levels in the peripheral venous blood of the participants

  3. circulating chemokines levels

    Time frame: within 24 hours of admission to the hospital

    examining the circulating chemokines levels in the peripheral venous blood of the participants

  4. circulating Cytochrome C level

    Time frame: within 24 hours of admission to the hospita

    examining the circulating cytochrome c levels in the peripheral venous blood of the participants

  5. circulating mitochondrial DNA levels

    Time frame: within 24 hours of admission to the hospital

    examining the circulating mitochondrial DNA levels in the peripheral venous blood of the participants

  6. circulating malondialdehyde levels

    Time frame: within 24 hours of admission to the hospital

    examining the circulating malondialdehyde levels in the peripheral venous blood of the participants

Secondary outcomes

  1. the relationship between FGFs/inflammatory cytokines/chemokines and troponin I (TnI)

    Time frame: within 24 hours of admission to the hospital

    performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and TnI

  2. the relationship between FGFs/inflammatory cytokines/chemokines and brain natriuretic peptide (BNP)

    Time frame: within 24 hours of admission to the hospital

    performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and BNP

  3. the relationship between FGFs/inflammatory cytokines/chemokines and lactate dehydrogenase (LDH)

    Time frame: within 24 hours of admission to the hospital

    performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and LDH

  4. the relationship between FGFs/inflammatory cytokines/chemokines and left ventricular ejection fraction (LVEF)

    Time frame: within 24 hours of admission to the hospital

    performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and LVEF

  5. the relationship between FGFs/inflammatory cytokines/chemokines and mitochondrial DNA (mitoDNA)

    Time frame: within 24 hours of admission to the hospital

    performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and mitochondrial DNA contents

  6. the relationship between FGFs/inflammatory cytokines/chemokines and cytochrome c

    Time frame: within 24 hours of admission to the hospital

    performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and cytochrome c

  7. the relationship between FGFs/inflammatory cytokines/chemokines and malondialdehyde

    Time frame: within 24 hours of admission to the hospital

    performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and malondialdehyde

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Niu, Doctor

CONTACT

[email protected]

86+18267806867

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Collaborators

  • The Central Hospital of Lishui City

Registry information

Official study title

A Study on Integrated Multi-Omics and Multi-Factor Analysis of Peripheral Blood in Patients With Acute Coronary Syndrome

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 2, 2025
Registry last updated
Jul 25, 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.

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