InflammationNCT05802667
A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
An observational study of Inflammation and Acute ST Segment Elevation Myocardial Infarction, run by Peking University Third Hospital.
Trial summary
By including patients with acute myocardial infarction, mast cell markers were analyzed and the relationship between mast cells and patients with acute myocardial infarction was analyzed Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Acute ST Segment Elevation Myocardial Infarction, Prognosis
- What is being tested?
- Tryptase
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Three hundred STEMI patients who meet the inclusion criteria and do not meet the exclusion criteria admitted to the Department of Cardiovascular Medicine of Peking University Third Hospital were continuously recruited.
Who may be able to join
- Age above 18 years old, regardless of gender;
- 2) Meet STEMI diagnostic criteria (diagnostic criteria: ischemic chest pain lasting ≥30min; ST segment elevation of more than two adjacent leads or new left bundle branch block in ECG; With or without elevated myocardial markers) and receiving standard care for STEMI.
- 3) Agree to and cooperate with the study
Who cannot join
- 1) The patient is taking or planning to take long-term oral or intravenous glucocorticoids (inhaled and topical hormones are allowed);
- 2) Allergic diseases, autoimmune diseases or malignant tumors.
- 3) Patients with metal implants or claustrophobia are not allowed to undergo an MRI examination;
- 4) Pregnancy or lactation
Trial locations and contacts
No sites are listed yet.
Ming Cui, Doctor contact
About this study
By including patients with acute myocardial infarction, mast cell markers were analyzed and the relationship between mast cells and patients with acute myocardial infarction was analyzed
Read the detailed description
Percutaneous coronary intervention (PCI) is the best way to improve the prognosis of patients with acute ST-segment elevation myocardial infarction (STEMI). However, ischemia reperfusion injury, inappropriate ventricular remodeling, and myocardial fibrosis may still be present in STEMI after PCI, which may be related to the inflammatory response in STEMI. Mast cells (MC), their degranulation products and induction of a series of inflammatory cytokines play an important role in the inflammatory response. The purpose of this study was to evaluate the relationship between mast cell markers (trypsin, chymotrypsin) levels and prognosis after direct PCI in STEMI patients. We prospectively and continuously included STEMI patients undergoing standard therapy after direct PCI. Clinical data and blood samples were collected and followed up for 1 year to analyze mast cell markers and myocardial infarction size. As well as differences in echocardiography, markers of two-dimensional speck tracking techniques, inflammatory factors and major adverse cardiovascular events, to explore the relationship between mast cells and their products and ventricular remodeling and ischemia-reperfusion injury in STEMI patients, and to provide new ideas for treatment and new basis for optimization of STEMI treatment strategies.
- Being tested
- Tryptase
- Medical subject headings
- Inflammation, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TryptaseDiagnostic test
Serum samples were collected from patients within 24 hours, 1 month, 3 months and 12 months after myocardial infarction, and trypsin-like enzymes were determined by elisa
| Study group | Role | What they receive |
|---|---|---|
| STEMI | A total of 300 STEMI patients admitted to the Department of Cardiology, Peking University Third Hospital from April 1, 2023 to March 31, 2024 were enrolled. Receives: Diagnostic Test: Tryptase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarct size
Myocardial infarct size was assessed by cardiac MRI
Measured: 3 months after myocardial infarction
Secondary outcomes (6)
left ventricular systolic function
Transthoracic echocardiography to measure LVEF, left ventricular end-diastolic diameter, Em/Sm
Measured: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
Left ventricular ultrasound strain
Two-dimensional speckle tracking imaging measures the movement in the long-axis direction as the overall longitudinal strain, the movement in the short-axis direction as the overall radial strain, reflecting the degree of wall systolic thickening, and the annular motion in the short-axis direction as the overall circumferential strain
Measured: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
inflammatory marker such as TNF-α
Measured: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
inflammatory markers e.g. IL1, IL6
Measured: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
MC marker (chymotrypsin)
Measured: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
major adverse cardiovascular events
MACE events (death, nonfatal myocardial infarction, unplanned revascularization, hospitalization for angina and readmission for heart failure)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Cui, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802667
- Sponsor's protocol ID
- M2023124
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie P, Xu S, Chen X, Xu H, Zhang R, Li D, Sun L, Zhu D, Cui M. Tryptase as a Biomarker for Adverse Prognosis in ST-Segment Elevation Myocardial Infarction Patients: A Prospective Cohort Study. J Inflamm Res. 2025 Mar 14;18:3817-3828. doi: 10.2147/JIR.S502496. eCollection 2025.
PubMed 40103802
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05802667
- Acronym / sponsor ID
- M2023124
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Apr 2023 (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.
By including patients with acute myocardial infarction, mast cell markers were analyzed and the relationship between mast cells and patients with acute myocardial infarction was analyzed
Detailed description
Percutaneous coronary intervention (PCI) is the best way to improve the prognosis of patients with acute ST-segment elevation myocardial infarction (STEMI). However, ischemia reperfusion injury, inappropriate ventricular remodeling, and myocardial fibrosis may still be present in STEMI after PCI, which may be related to the inflammatory response in STEMI. Mast cells (MC), their degranulation products and induction of a series of inflammatory cytokines play an important role in the inflammatory response. The purpose of this study was to evaluate the relationship between mast cell markers (trypsin, chymotrypsin) levels and prognosis after direct PCI in STEMI patients. We prospectively and continuously included STEMI patients undergoing standard therapy after direct PCI. Clinical data and blood samples were collected and followed up for 1 year to analyze mast cell markers and myocardial infarction size. As well as differences in echocardiography, markers of two-dimensional speck tracking techniques, inflammatory factors and major adverse cardiovascular events, to explore the relationship between mast cells and their products and ventricular remodeling and ischemia-reperfusion injury in STEMI patients, and to provide new ideas for treatment and new basis for optimization of STEMI treatment strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | Diagnostic Test: TryptaseA total of 300 STEMI patients admitted to the Department of Cardiology, Peking University Third Hospital from April 1, 2023 to March 31, 2024 were enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three hundred STEMI patients who meet the inclusion criteria and do not meet the exclusion criteria admitted to the Department of Cardiovascular Medicine of Peking University Third Hospital were continuously recruited.
Key inclusion criteria (3 listed)
- Age above 18 years old, regardless of gender;
- 2) Meet STEMI diagnostic criteria (diagnostic criteria: ischemic chest pain lasting ≥30min; ST segment elevation of more than two adjacent leads or new left bundle branch block in ECG; With or without elevated myocardial markers) and receiving standard care for STEMI.
- 3) Agree to and cooperate with the study
Key exclusion criteria (4 listed)
- 1) The patient is taking or planning to take long-term oral or intravenous glucocorticoids (inhaled and topical hormones are allowed);
- 2) Allergic diseases, autoimmune diseases or malignant tumors.
- 3) Patients with metal implants or claustrophobia are not allowed to undergo an MRI examination;
- 4) Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TryptaseSerum samples were collected from patients within 24 hours, 1 month, 3 months and 12 months after myocardial infarction, and trypsin-like enzymes were determined by elisa | Diagnostic test | STEMI |
Primary outcome
Myocardial infarct size
Time frame: 3 months after myocardial infarction
Myocardial infarct size was assessed by cardiac MRI
6 secondary outcomes
left ventricular systolic function
Time frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
Left ventricular ultrasound strain
Time frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
inflammatory marker such as TNF-α
Time frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
inflammatory markers e.g. IL1, IL6
Time frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
MC marker (chymotrypsin)
Time frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
major adverse cardiovascular events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 40103802Xie P, Xu S, Chen X, Xu H, Zhang R, Li D, Sun L, Zhu D, Cui M. Tryptase as a Biomarker for Adverse Prognosis in ST-Segment Elevation Myocardial Infarction Patients: A Prospective Cohort Study. J Inflamm Res. 2025 Mar 14;18:3817-3828. doi: 10.2147/JIR.S502496. eCollection 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ming Cui, Doctor contact
Ming Cui principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Acute ST Segment Elevation Myocardial Infarction, run by Peking University Third Hospital.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengxin Xie (+8618810793282, xiepengxin2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarct size (time frame: 3 months after myocardial infarction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802667, which also lists 1 linked publication.
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 6 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.