NCT05802667

Brief 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

March 26, 2023

Last Update Submit

April 5, 2023

Conditions

InflammationAcute ST Segment Elevation Myocardial InfarctionPrognosis

Outcome Measures

Primary Outcomes (1)

  • Myocardial infarct size

    Myocardial infarct size was assessed by cardiac MRI

    3 months after myocardial infarction

Secondary Outcomes (6)

  • left ventricular systolic function

    24 hours, 1 month, 3 months, and 12 months after myocardial infarction

  • Left ventricular ultrasound strain

    24 hours, 1 month, 3 months, and 12 months after myocardial infarction

  • inflammatory marker such as TNF-α

    24 hours, 1 month, 3 months, and 12 months after myocardial infarction

  • inflammatory markers e.g. IL1, IL6

    24 hours, 1 month, 3 months, and 12 months after myocardial infarction

  • MC marker (chymotrypsin)

    24 hours, 1 month, 3 months, and 12 months after myocardial infarction

  • +1 more secondary outcomes

Study Arms (1)

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.

Diagnostic Test: Tryptase

Interventions

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

STEMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age above 18 years old, regardless of gender;
  • \) 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.
  • \) Agree to and cooperate with the study

You may not qualify if:

  • \) The patient is taking or planning to take long-term oral or intravenous glucocorticoids (inhaled and topical hormones are allowed);
  • \) Allergic diseases, autoimmune diseases or malignant tumors.
  • \) Patients with metal implants or claustrophobia are not allowed to undergo an MRI examination;
  • \) Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 40103802DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples were collected from patients within 24 hours, 1 month, 3 months and 12 months after myocardial infarction

MeSH Terms

Conditions

InflammationST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosis

Study Officials

  • Ming Cui

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengxin Xie

CONTACT

+8618810793282xiepengxin2014@163.com

Ming Cui, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 6, 2023

Study Start

April 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

April 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share