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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05802667
• Other study ID #: M2023124
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Peking University Third Hospital
• Contact: Pengxin Xie
• Phone: +8618810793282
• Email: xiepengxin2014[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute ST Segment Elevation Myocardial Infarction
• Infarction
• Inflammation
• Myocardial Infarction
• Prognosis
• ST Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial infarct size	Myocardial infarct size was assessed by cardiac MRI	3 months after myocardial infarction
Secondary	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
Secondary	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
Secondary	inflammatory marker such as TNF-a		24 hours, 1 month, 3 months, and 12 months after myocardial infarction
Secondary	inflammatory markers e.g. IL1, IL6		24 hours, 1 month, 3 months, and 12 months after myocardial infarction
Secondary	MC marker (chymotrypsin)		24 hours, 1 month, 3 months, and 12 months after myocardial infarction
Secondary	major adverse cardiovascular events	MACE events (death, nonfatal myocardial infarction, unplanned revascularization, hospitalization for angina and readmission for heart failure)	12 months