Clinical trial NCT05802667: A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
Official title: A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammation
Acute ST Segment Elevation Myocardial Infarction
Prognosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Myocardial infarct size
timeFrame: 3 months after myocardial infarction
Secondary outcomes:
measure: left ventricular systolic function
timeFrame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
measure: Left ventricular ultrasound strain
timeFrame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
measure: inflammatory marker such as TNF-α
timeFrame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
measure: inflammatory markers e.g. IL1, IL6
timeFrame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
measure: MC marker (chymotrypsin)
timeFrame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
measure: major adverse cardiovascular events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Ming Cui
role: PRINCIPAL_INVESTIGATOR
References: