NCT06955143

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

April 24, 2025

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • circulating fibroblast growth factors (FGFs) levels

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

    within 24 hours of admission to the hospital

  • circulating inflammatory cytokines levels

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

    within 24 hours of admission to the hospital

  • circulating chemokines levels

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

    within 24 hours of admission to the hospital

  • circulating Cytochrome C level

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

    within 24 hours of admission to the hospita

  • circulating mitochondrial DNA levels

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

    within 24 hours of admission to the hospital

  • circulating malondialdehyde levels

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

    within 24 hours of admission to the hospital

Secondary Outcomes (7)

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

    within 24 hours of admission to the hospital

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

    within 24 hours of admission to the hospital

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

    within 24 hours of admission to the hospital

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

    within 24 hours of admission to the hospital

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

    within 24 hours of admission to the hospital

  • +2 more secondary outcomes

Study Arms (3)

ACS

those with a condition of Acute Coronary Syndrome

Control

patients without coronary artery disease, valvular heart disease, structural heart disease, or any other kind of cardiomyopathy

CCS

those with a condition of Chronic Coronary Syndrome

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who presented to Lishui Central Hospital (Fifth Affiliated Hospital of Wenzhou Medical University) due to cardiac discomfort or other related symptoms were consecutively enrolled in the present study.

You may qualify if:

  • 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.
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lishui Central Hospital

Lishui, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Chao Niu, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 2, 2025

Study Start

March 11, 2025

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

July 25, 2025

Record last verified: 2025-07

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