Acute Coronary SyndromeNCT06955143
A Study on the Peripheral Blood in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome and Chronic Coronary Syndrome, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Chronic Coronary Syndrome
- How many people
- 310 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Lactating or pregnant women
- Patients with malignant neoplasms
- Severe hepatic/renal dysfunction
- Severe hematological disorders
- Autoimmune diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang
Jiayi Shen, 86+15990735525, lemon33068428@126.com
About this study
Official title: A Study on Integrated Multi-Omics and Multi-Factor Analysis of 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.
- Conditions
- Acute Coronary Syndrome, Chronic Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating fibroblast growth factors (FGFs) levels
examining the circulating fibroblast growth factors levels in the peripheral venous blood of the participants
Measured: 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
Measured: within 24 hours of admission to the hospital
circulating chemokines levels
examining the circulating chemokines levels in the peripheral venous blood of the participants
Measured: 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
Measured: 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
Measured: within 24 hours of admission to the hospital
circulating malondialdehyde levels
examining the circulating malondialdehyde levels in the peripheral venous blood of the participants
Measured: within 24 hours of admission to the hospital
Secondary outcomes (7)
the relationship between FGFs/inflammatory cytokines/chemokines and troponin I (TnI)
performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and TnI
Measured: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and brain natriuretic peptide (BNP)
performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and BNP
Measured: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and lactate dehydrogenase (LDH)
performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and LDH
Measured: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and left ventricular ejection fraction (LVEF)
performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and LVEF
Measured: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and mitochondrial DNA (mitoDNA)
performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and mitochondrial DNA contents
Measured: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and cytochrome c
performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and cytochrome c
Measured: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and malondialdehyde
performed correlation analyses between the circulating levels of FGFs/inflammatory cytokines/chemokines and malondialdehyde
Measured: within 24 hours of admission to the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start11 Mar 2025
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Central Hospital of Lishui City
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955143
- Sponsor's protocol ID
- SAHoWMU-CR2025-06-218
- Status last verified
- Jul 2025
- First submitted
- 24 Apr 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Integrated Multi-Omics and Multi-Factor Analysis of Peripheral Blood in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06955143
- Acronym / sponsor ID
- SAHoWMU-CR2025-06-218
- Conditions
- Acute Coronary Syndrome, Chronic Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- The Central Hospital of Lishui City
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (5 listed)
- Lactating or pregnant women
- Patients with malignant neoplasms
- Severe hepatic/renal dysfunction
- Severe hematological disorders
- Autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
7 secondary outcomes
the relationship between FGFs/inflammatory cytokines/chemokines and troponin I (TnI)
Time frame: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and brain natriuretic peptide (BNP)
Time frame: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and lactate dehydrogenase (LDH)
Time frame: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and left ventricular ejection fraction (LVEF)
Time frame: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and mitochondrial DNA (mitoDNA)
Time frame: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and cytochrome c
Time frame: within 24 hours of admission to the hospital
the relationship between FGFs/inflammatory cytokines/chemokines and malondialdehyde
Time frame: within 24 hours of admission to the hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Chronic Coronary Syndrome, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Niu, Doctor (86+18267806867, davidduoduo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating fibroblast growth factors (FGFs) levels (time frame: within 24 hours of admission to the hospital). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.