NCT05251987

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 23, 2022

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

January 17, 2022

Last Update Submit

February 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    at admission, 1 month , 3 months

Secondary Outcomes (1)

  • Patient-oriented composite outcome

    3 months

Study Arms (2)

High PD1+ T Cell Expression

high PD1+ T cell expression in peripheral blood

Biological: PD1+ T Cell Expression

Low PD1+ T Cell Expression

low PD1+ T cell expression in peripheral blood

Biological: PD1+ T Cell Expression

Interventions

The expression of PD1+ T cells was detected by flow cytometry in peripheral blood

High PD1+ T Cell ExpressionLow PD1+ T Cell Expression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Study Officials

  • Jianan Wang, MD, PhD

    2nd Affiliated Hospital, School of Medicine at Zhejiang University

    STUDY CHAIR
  • Xinyang Hu, MD, PhD

    2nd Affiliated Hospital, School of Medicine at Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2022

First Posted

February 23, 2022

Study Start

October 1, 2021

Primary Completion

June 1, 2022

Study Completion

December 30, 2022

Last Updated

February 23, 2022

Record last verified: 2021-10

Locations