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

Not yet recruiting

• Conditions: Inflammation; Acute ST Segment Elevation Myocardial Infarction; Prognosis
• Interventions: Diagnostic Test: Tryptase

• Registration Number: NCT05802667
• Lead Sponsor: Peking University Third Hospital

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

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 Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-26
• Study Start: 2023-04-01
• Study First Submitted QC: 2023-04-05
• Last Update Submitted: 2023-04-05
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STEMI	Tryptase	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.

Primary Outcome Measures

Name	Time	Method
Myocardial infarct size	3 months after myocardial infarction	Myocardial infarct size was assessed by cardiac MRI

Secondary Outcome Measures

Name	Time	Method
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
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
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
major adverse cardiovascular events	12 months	MACE events (death, nonfatal myocardial infarction, unplanned revascularization, hospitalization for angina and readmission for heart failure)