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RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05131750
Collaborator
(none)
1,408
Enrollment
1
Location
67.8
Anticipated Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Coronary heart disease (CAD) is caused by myocardial ischemia, hypoxia or necrosis due to coronary artery stenosis, spasm or obstruction. Although standard drug therapy can greatly improve the prognosis of patients with CAD after percutaneous coronary interventions (PCI), these patients are still at high risk of major adverse cardiovascular events (MACE).

At present, the concept of residual inflammation risk (RIR) has aroused widespread concern. RIR is an important independent risk in patients with CAD. Foreign studies indicate that hsCRP ≥ 2mg / L is the definition standard of RIR in CAD. In China, there is no defined value of RIR for patients undergoing PCI, and the incidence of RIR has not been investigated clearly. At the same time, the impact of dynamic changes of hsCRP on MACE in PCI population needs to be further explored. Therefore, in this study, we plan to recruit patients undergoing PCI, and observe the impact of RIR by serial hsCRP measurements on the prognosis of these patients followed up for 5 years.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Serial hsCRP measurements with ≥ 4 weeks between both measurements are defined in this analysis. Time-to-event is measured from first hsCRP measurement.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1408 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Study of Residual Inflammatory Risk and the Impact on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Interventions
    Actual Study Start Date :
    May 6, 2021
    Anticipated Primary Completion Date :
    May 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Major adverse cardiovascular events (MACEs) [60 months]

      Time to occurrence of composite endpoint of all-cause death, nonfatal myocardial infarction or nonfatal stroke

    Secondary Outcome Measures

    1. Major adverse cardiovascular events + (MACEs+) [60 months]

      Time to occurrence of composite endpoints of all-cause death, nonfatal myocardial infarction, nonfatal stroke, revascularization due to ischemia, or hospitalization due to unstable angina pectoris

    2. All-cause death [60 months]

      Time to occurrence of all-cause death

    3. Cardiovascular death [60 months]

      Time to occurrence of cardiovascular death

    4. Nonfatal myocardial infarction [60 months]

      Time to occurrence of nonfatal myocardial infarction

    5. Hospitalization due to unstable angina pectoris [60 months]

      Time to occurrence of hospitalization due to unstable angina pectoris

    6. Revascularization due to ischemia [60 months]

      Time to occurrence of revascularization due to ischemia

    7. In-stent thrombosis [60 months]

      Time to occurrence of in-stent thrombosis

    8. Nonfatal stroke [60 months]

      Time to occurrence of nonfatal stroke

    9. Bleeding [60 months]

      Time to occurrence of bleeding

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Participants who understand and sign the informed consent form voluntarily;

    2. Age ≥ 18 years old and ≤ 80 years old, regardless of sex;

    3. The hospitalized patients with coronary heart disease undergoing PCI;

    4. Complete all planned PCI during hospitalization

    Exclusion Criteria:

    1. Patients do not receive standardized treatment according to guidelines after being diagnosed with coronary heart disease;

    2. Uncontrolled infectious diseases during the screening period;

    3. In the screening stage, patients with immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on;

    4. Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs during the study period;

    5. Surgical or interventional treatment was performed within 3 months before the screening period;

    6. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;

    7. Participated in other clinical trials within 3 months before the screening period;

    8. The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430022

    Sponsors and Collaborators

    • Wuhan Union Hospital, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiang Cheng, Head of department of cardiology, Wuhan Union Hospital, China, Wuhan Union Hospital, China
    ClinicalTrials.gov Identifier:
    NCT05131750
    Other Study ID Numbers:
    • RIR-PCI
    First Posted:
    Nov 23, 2021
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 23, 2021