Influence of Risk Factors on ISR and Nonintervened Lesions

Sponsor
RenJi Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06039059
Collaborator
(none)
510
1
38.9
13.1

Study Details

Study Description

Brief Summary

This study enrolled patients who used to received PCI therapy with nonintervened coronary lesions. Baseline characteristics and laboratory testing were collected to find out the risk factor difference between ISR and nonintervened coronary lesions.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    510 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Influence of Risk Factors Such as Serum Cholesterol Level on ISR and Nonintervened Coronary Lesions
    Actual Study Start Date :
    Jan 1, 2020
    Actual Primary Completion Date :
    Dec 31, 2022
    Actual Study Completion Date :
    Mar 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Receiving PCI with nonintervened coronary lesion

    Patients who received PCI with nonintervened coronary lesion.

    Outcome Measures

    Primary Outcome Measures

    1. LDL-C, mmol/L [Blood samples were collected after a 12-hour fast before CAG.]

      Low-density cholesterol (LDL-C) is the cholesterol in low-density lipoprotein (LDL), which reflects how much LDL is present.

    Secondary Outcome Measures

    1. HbA1c, % [Blood samples were collected after a 12-hour fast before CAG.]

      Hemoglobin a1c (HbA1c) is the combination of hemoglobin and blood sugar. Its concentration in the blood is stable and is not affected by short-term blood sugar concentrations. Hemoglobin A1C has obvious clinical value in the diagnosis of diabetes.

    2. ALT, U/L [Blood samples were collected after a 12-hour fast before CAG.]

      Alanine aminotransferase (ALT) mainly exists in the plasma of liver cells, and the intracellular concentration is 1000-3000 times higher than that in serum. As long as 1% of liver cells are destroyed, it can double the serum enzyme. Therefore, alanine transaminase is recommended by the World Health Organization as the most sensitive detection index of liver function damage.

    3. Scr, mmol/L [Blood samples were collected after a 12-hour fast before CAG.]

      Serum creatinine (Scr) is a compound produced in muscles during the production of energy. Healthy kidneys filter creatinine from the blood. Creatinine is excreted in the urine as a metabolite and is a common measure of the kidney's filtration function. Creatinine this indicator belongs to the blood biochemical test, the higher the creatinine level, usually indicates the worse the kidney function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • (1) PCI therapy with drug-coated stents was performed in the past, and nonintervened coronary lesion remained except in the target vessel.

    (2) CAG was performed again due to re-examination, recurrent angina symptoms, positive treadmill exercise test or coronary CTA showing moderate to severe vessel diameter stenosis.

    (3) Long-term regular oral administration of statins and lipid monitoring were conducted after PCI.

    Exclusion Criteria:
    • Patients with a history of CABG, renal replacement therapy, autoimmune disease, and malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renji Hospital Shanghai China 200127

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT06039059
    Other Study ID Numbers:
    • Rf on ISR and nonintervented
    First Posted:
    Sep 15, 2023
    Last Update Posted:
    Sep 15, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RenJi Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 15, 2023