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

April 5, 2023 updated by: Peking University Third Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ming Cui, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Myocardial infarct size
Time Frame: 3 months after myocardial infarction
Myocardial infarct size was assessed by cardiac MRI
3 months after myocardial infarction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
left ventricular systolic function
Time Frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
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
Time Frame: 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
24 hours, 1 month, 3 months, and 12 months after myocardial infarction
major adverse cardiovascular events
Time Frame: 12 months
MACE events (death, nonfatal myocardial infarction, unplanned revascularization, hospitalization for angina and readmission for heart failure)
12 months
inflammatory marker such as TNF-α
Time Frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
24 hours, 1 month, 3 months, and 12 months after myocardial infarction
inflammatory markers e.g. IL1, IL6
Time Frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
24 hours, 1 month, 3 months, and 12 months after myocardial infarction
MC marker (chymotrypsin)
Time Frame: 24 hours, 1 month, 3 months, and 12 months after myocardial infarction
24 hours, 1 month, 3 months, and 12 months after myocardial infarction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ming Cui, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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