- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05251987
Comparison of PD1+T Cell Expression in Peripheral Blood for Cardiac Function Prognosis in Patients With Acute MI
Comparison of High PD1+ T Cell and Low PD1+ T Cell Expression in Peripheral Blood for Cardiac Function Prognosis in Patients With Acute Myocardial Infarction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Myocardial infarction is a serious common disease in human beings. Although many patients with acute myocardial infarction survive with the improvement of medical technology in recent years, studies have shown that cardiac remodeling caused by myocardial remodeling after myocardial infarction can still lead to heart failure. Severe heart failure is the main cause of death. Myocardial infarction is a process in which multiple cells interact and participate in post-infarction repair. The pathophysiological processes include early angiogenesis, myocardial compensatory hypertrophy and chronic rational myocardial remodeling and fibrosis. Accordingly, how immune inflammatory cells regulate angiogenesis and fibroblast activation during chronic myocardial remodeling are important therapeutic targets for improving the prognosis of myocardial infarction.Each phase after myocardial infarction has its characteristic pathophysiological changes. Studies have shown that immune inflammatory cells T cells are involved in the whole process of regulating the repair of myocardial infarction. Immune studies have shown that PD1/PD-L1, as a second stimulation signaling pathway besides the antigen TCR of T cells, has the ability to inhibit THE activity of T cells, so the inhibition of PD1/PD-L1 has become a research hotspot in the field of tumor therapy. A large number of studies have focused on the regulation mechanism of PD1/PD-L1 signaling pathway in tumor immune cell activity. Regarding PD1/PD-L1 as the mechanism of immune cell function change in non-tumor lesions, studies based on primary pulmonary hypertension and sarcoidosis have shown that PD1-positive CD4+ cells exhibit a process of promoting fibrosis. Therefore, blocking PD1 antibody can inhibit and improve pulmonary fibrosis. These data suggest that PD1 positive cells are involved in the pathologic process of pulmonary fibrosis. Preliminary data showed that PD1 expression levels were differentiated in peripheral blood of patients with acute myocardial infarction. Further study on the expression and corresponding role of PD1/PD-L1 signaling pathway in ventricular remodeling may provide a new target for the treatment of myocardial infarction remodeling.
This is a perspective, self-controlled cohort study. This study aims to Compare high PD1+ T cell and low PD1+ T cell expression in peripheral blood for cardiac function prognosis in Patients with acute myocardial infarction.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Changle Ke, PhD
- Phone Number: +86 15757102667
- Email: keheart@zju.edu.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China
- Recruiting
- The Second Affiliated Hospital of Zhejiang University, School of Medicine
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Contact:
- Changle Ke, PhD
- Phone Number: +86 15757102667
- Email: keheart@zju.edu.cn
-
Principal Investigator:
- Xinyang Hu, MD, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over 18 years of age;
- Understand oral confirm to accept the risks and benefits of this experiment could bring He (she) or its legal representative in experiment related to provide written informed consent before surgery;
- Was diagnosed with st-elevation acute myocardial infarction;
- Based on the visual assessment of coronary angiography of coronary artery stenosis degree is 50% and the row stenting patients;
- The target vessels are limited to the main coronary arteries (including the left anterior descending, left circumflex, and right coronary arteries).
Exclusion Criteria:
- Pregnant or lactating women; Patients with previous malignant tumors or mental diseases; Recent major trauma/trauma, or surgical treatment; Drug, drug and alcohol abusers; Those who have been receiving antitumor drugs, immunosuppressants, hormones and antibiotics for a long time; People with blood-borne infectious diseases (including hepatitis B, c, syphilis, AIDS, etc.);
- People with immune deficiency diseases or autoimmune diseases; Liver and kidney dysfunction; Aortic dissection, pulmonary embolism, acute myocarditis or severe valvular disease; One who is in the acute phase of any illness (influenza, pneumonia, gastroenteritis, skin disease, etc.).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
High PD1+ T Cell Expression
high PD1+ T cell expression in peripheral blood
|
The expression of PD1+ T cells was detected by flow cytometry in peripheral blood
|
Low PD1+ T Cell Expression
low PD1+ T cell expression in peripheral blood
|
The expression of PD1+ T cells was detected by flow cytometry in peripheral blood
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac function(echocardiography) recovery after 1 and 3 months was measured compared with baseline(at admission).
Time Frame: at admission, 1 month , 3 months
|
Compare the changes of ejection fraction(%) at 1 and 3 months with baseline(at admission)
|
at admission, 1 month , 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-oriented composite outcome
Time Frame: 3 months
|
Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or any revascularization at 3 months according to the ARC definitions.
|
3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Xinyang Hu, MD, PhD, 2nd Affiliated Hospital, School of Medicine at Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0725
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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