PD1NCT05251987
Comparison of PD1+T Cell Expression in Peripheral Blood for Cardiac Function Prognosis in Patients With Acute MI
An observational study of PD1 and Acute Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PD1, Acute Myocardial Infarction
- What is being tested?
- PD1+ T Cell Expression
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to the department of Cardiology with a diagnosis of ST-segment elevation acute myocardial infarction, angiography indicating 50% stenosis of at least one major coronary artery and stent implantation were selected
Who may be able to join
- 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).
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang
Jianan Wang, MD, PhD, +86 0571 87784808, wangjianan111@zju.edu.cn
Changle Ke, PhD, +86 15757102667, keheart@zju.edu.cn
About this study
Official title: 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
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
Read the 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.
- Conditions
- PD1, Acute Myocardial Infarction
- Being tested
- PD1+ T Cell Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD1+ T Cell ExpressionBiological
The expression of PD1+ T cells was detected by flow cytometry in peripheral blood
| Study group | Role | What they receive |
|---|---|---|
| High PD1+ T Cell Expression | high PD1+ T cell expression in peripheral blood Receives: Biological: PD1+ T Cell Expression | |
| Low PD1+ T Cell Expression | low PD1+ T cell expression in peripheral blood Receives: Biological: PD1+ T Cell Expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function(echocardiography) recovery after 1 and 3 months was measured compared with baseline(at admission).
Compare the changes of ejection fraction（%） at 1 and 3 months with baseline(at admission)
Measured: at admission, 1 month , 3 months
Secondary outcomes (1)
Patient-oriented composite outcome
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Oct 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD1Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First People's Hospital of Hangzhou
- Responsible party
- Sponsor
- Investigators
- Jianan Wang, MD, PhD, Study chair, 2nd Affiliated Hospital, School of Medicine at Zhejiang UniversityXinyang Hu, MD, PhD, Study director, 2nd Affiliated Hospital, School of Medicine at Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251987
- Sponsor's protocol ID
- 2021-0725
- Status last verified
- Oct 2021
- First submitted
- 17 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05251987
- Acronym / sponsor ID
- 2021-0725
- Conditions
- PD1, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First People's Hospital of Hangzhou
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High PD1+ T Cell Expression | – | Biological: PD1+ T Cell Expressionhigh PD1+ T cell expression in peripheral blood |
| Low PD1+ T Cell Expression | – | Biological: PD1+ T Cell Expressionlow PD1+ T cell expression in peripheral blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the department of Cardiology with a diagnosis of ST-segment elevation acute myocardial infarction, angiography indicating 50% stenosis of at least one major coronary artery and stent implantation were selected
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD1+ T Cell ExpressionThe expression of PD1+ T cells was detected by flow cytometry in peripheral blood | Biological | High PD1+ T Cell Expression, Low PD1+ T Cell Expression |
Primary outcome
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)
1 secondary outcome
Patient-oriented composite outcome
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianan Wang, MD, PhD study chair
2nd Affiliated Hospital, School of Medicine at Zhejiang University
Xinyang Hu, MD, PhD study director
2nd Affiliated Hospital, School of Medicine at Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PD1 and Acute Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianan Wang, MD, PhD (+86 0571 87784808, wangjianan111@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac function(echocardiography) recovery after 1 and 3 months was measured compared with baseline(at admission). (time frame: at admission, 1 month , 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.