Clinical trial NCT06955143: A Study on the Peripheral Blood in Patients With Acute Coronary Syndrome
Official title: A Study on Integrated Multi-Omics and Multi-Factor Analysis of Peripheral Blood in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: The Central Hospital of Lishui City
First posted: 2025-05-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

Brief summary: The goal of this study is to conduct analyses on 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 control group (patients without coronary artery disease, 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.


Eligibility criteria: Inclusion Criteria:

For acute coronary syndrome (ACS) group ST-segment elevation myocardial infarction (STEMI)

* Cardiac troponin (cTn)\>99th upper limit of normal (ULN) or creatine kinase-myocardial band (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.

Non-ST-segment elevation myocardial infarction (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.

Unstable angina (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 For control gourp
* Patients without coronary artery disease, 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

Primary outcomes:
measure: circulating fibroblast growth factors (FGFs) levels
timeFrame: within 24 hours of admission to the hospital
measure: circulating inflammatory cytokines levels
timeFrame: within 24 hours of admission to the hospital
measure: circulating chemokines levels
timeFrame: within 24 hours of admission to the hospital
Secondary outcomes:
measure: the relationship between FGFs/inflammatory cytokines/chemokines and troponin I (TnI)
timeFrame: within 24 hours of admission to the hospital
measure: the relationship between FGFs/inflammatory cytokines/chemokines and brain natriuretic peptide (BNP)
timeFrame: within 24 hours of admission to the hospital
measure: the relationship between FGFs/inflammatory cytokines/chemokines and lactate dehydrogenase (LDH)
timeFrame: within 24 hours of admission to the hospital
measure: the relationship between FGFs/inflammatory cytokines/chemokines and left ventricular ejection fraction (LVEF)
timeFrame: within 24 hours of admission to the hospital
measure: the relationship between FGFs/inflammatory cytokines/chemokines and mitochondrial DNA (mitoDNA)
timeFrame: within 24 hours of admission to the hospital
Other outcomes:
Locations:
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
Study officials:
References: