A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction

Sponsor
Peking University Third Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05802667
Collaborator
(none)
300
33

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Tryptase

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

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

  1. Myocardial infarct size [3 months after myocardial infarction]

    Myocardial infarct size was assessed by cardiac MRI

Secondary Outcome Measures

  1. left ventricular systolic function [24 hours, 1 month, 3 months, and 12 months after myocardial infarction]

    Transthoracic echocardiography to measure LVEF, left ventricular end-diastolic diameter, Em/Sm

  2. Left ventricular ultrasound strain [24 hours, 1 month, 3 months, and 12 months after myocardial infarction]

    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

  3. inflammatory marker such as TNF-α [24 hours, 1 month, 3 months, and 12 months after myocardial infarction]

  4. inflammatory markers e.g. IL1, IL6 [24 hours, 1 month, 3 months, and 12 months after myocardial infarction]

  5. MC marker (chymotrypsin) [24 hours, 1 month, 3 months, and 12 months after myocardial infarction]

  6. major adverse cardiovascular events [12 months]

    MACE events (death, nonfatal myocardial infarction, unplanned revascularization, hospitalization for angina and readmission for heart failure)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age above 18 years old, regardless of gender;

    1. 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.
    1. Agree to and cooperate with the study
Exclusion Criteria:
    1. The patient is taking or planning to take long-term oral or intravenous glucocorticoids (inhaled and topical hormones are allowed);
    1. Allergic diseases, autoimmune diseases or malignant tumors.
    1. Patients with metal implants or claustrophobia are not allowed to undergo an MRI examination;
    1. Pregnancy or lactation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

  • Principal Investigator: Ming Cui, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT05802667
Other Study ID Numbers:
  • M2023124
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 6, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2023