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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammation; Prognosis; Acute ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Pengxin Xie; Phone Number: +8618810793282; Email: xiepengxin2014@163.com
• Study Contact Backup: Name: Ming Cui, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarct size	Myocardial infarct size was assessed by cardiac MRI	3 months after myocardial infarction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
left ventricular systolic function	Transthoracic echocardiography to measure LVEF, left ventricular end-diastolic diameter, Em/Sm	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	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)	12 months
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Ming Cui, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction; Inflammation
• Other Study ID Numbers: M2023124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No