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The Usefulness of CaIMR in Patients With STEMI

Sponsor
Zhongnan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04984915
Collaborator
(none)
400
Enrollment
1
Location
18.6
Anticipated Duration (Months)
21.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The coronary artery system is composed of three different types of blood vessels, namely epicardial arteries, arterioles and capillaries. Compared with epicardial arteries, arterioles and capillaries are lower than the resolution of current angiography systems, so angiography cannot be used for visualization. Existing studies have shown that coronary microcirculation plays an extremely important role in maintaining full myocardial perfusion. Coronary microvascular disorders can lead to myocardial hypoperfusion and ischemia, and are related to the poor prognosis of patients with coronary heart disease. At present, there is no technology that can directly detect the state of the coronary microcirculation in the human body, but the coronary microcirculation function can be indirectly assessed through two invasive and non-invasive methods. Among them, the index of microcirculation resistance (IMR) is widely used to evaluate coronary microcirculation function [3]. However, in the case of epicardial stenosis, accurate determination of IMR requires knowledge of coronary artery contraction pressure (Pw). However, measuring IMR is an invasive examination technique, and measuring IMR requires high technical requirements for the operator. Therefore, the CaIMR value obtained by AI technology can well overcome this limitation, and the existing data show that the CaIMR value has a good correlation with the IMR value. However, CaIMR has a clinical prognosis for patients with acute ST-segment elevation myocardial infarction. The predictive value of CaIMR has not yet been explored. This project aims to evaluate the application value of CaIMR in predicting the occurrence of adverse cardiovascular events in patients with acute ST-segment elevation myocardial infarction after percutaneous coronary intervention.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Long-term Prognostic Value of CaIMR in Patients With ST-segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention
    Anticipated Study Start Date :
    May 15, 2022
    Anticipated Primary Completion Date :
    Aug 15, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. The composite endpoint of all-cause death and heart failure rehospitalization [1 year after surgery]

      The composite endpoint of all-cause death and heart failure rehospitalization

    Secondary Outcome Measures

    1. The composite endpoint of all-cause death and heart failure rehospitalization [1 month after surgery]

      The composite endpoint of all-cause death and heart failure rehospitalization

    2. All-cause death [1 year after surgery]

      All-cause death

    3. All-cause death [1 month after surgery]

      All-cause death

    4. Heart failure rehospitalization [1 year after surgery]

      Heart failure rehospitalization

    5. Heart failure rehospitalization [1 month after surgery]

      Heart failure rehospitalization

    6. Cardiogenic Rehospitalization [1 year after surgery]

      Cardiogenic Rehospitalization

    7. Cardiogenic Rehospitalization [1 month after surgery]

      Cardiogenic Rehospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who are clinically diagnosed with acute ST-segment elevation myocardial infarction and are planned to undergo PCI;

    • Volunteer to participate and sign the informed consent

    Exclusion Criteria:

    • Coronary angiography suggests that it is not suitable for PCI;

    • Have performed CABG surgery in the past;

    • Lesion of left or right coronary ostium;

    • The target vessel is an infarct-related artery (old or acute myocardial infarction recovery period);

    • The immediate effect of target vessel PCI is not ideal (such as: final TIMI blood flow <grade 3, dissection with restricted blood flow, side branch occlusion with diameter> 1.5 mm, distal embolism or thrombus shown by angiography);

    • Severe systemic infection;

    • Patients with malignant wasting disease whose estimated survival time is less than 1 year.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430071

    Sponsors and Collaborators

    • Zhongnan Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhibing Lu, The chief of cardiology department, Zhongnan Hospital
    ClinicalTrials.gov Identifier:
    NCT04984915
    Other Study ID Numbers:
    • 2021075
    First Posted:
    Aug 2, 2021
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myocardial Infarction
    ST Elevation Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Feb 9, 2022