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Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment

Sponsor
Zibo Central Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04416425
Collaborator
(none)
200
Enrollment
1
Location
19
Anticipated Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Compelling evidences indicate that lipid-lowering therapy can reduce the high-risk plaque feathers and improve the coronary flow reserve. This study is going to investigate the change of lesion-specific hemodynamic significance as determined by ML(Machine Learning)-based CT-FFR (Computed Tomography-Fractional Flow Reserve)after Evolocumab treatment.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment: A Serial Follow-Up Study by Computed Tomography-Derived Fractional Flow Reserve
    Anticipated Study Start Date :
    Jul 30, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Feb 27, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Enrolled Cohort

    200 selected patients will be recruited, who have diagnosed with coronary atherosclerosis disease(stenotic extent from 50% to 69% on major epicardial arteries) by coronary computed tomography angiography(CCTA). Every two weeks, these patients will be treated with Elococumab Injection (1ml:140mg),ih.This therapy will last for one year.

    Outcome Measures

    Primary Outcome Measures

    1. the change of lesion-specific CT-FFR [June 2020 to December 2021]

      After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure the proximal and distal CT-FFR for each lesion.At the same time ,we will calculated the change in CT-FFR value across the lesion(ΔCT-FFR=CT-FFRproximal-CT-FFRdistal).To compare the parameters above,we shall identify whether the treatment of Elovocumab Injection improves the lesion-specific CT-FFR.

    Other Outcome Measures

    1. the change of minimal lumen diameter between baseline and follow-up CCTA [June 2020 to December 2021]

      After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure the minimal lumen diameter for each lesion. Minimal lumen diameter will be manually measured with a digital caliper at the narrowest level of the lesion using the crosssectional images accroding to the CCTA findings. The results of the minimal lumen diameter at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy.

    2. the change of total plaque volume (TPV) between baseline and follow-up CCTA [June 2020 to December 2021]

      After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure TPV for each lesion. Total plaque volume will be automatically measured using the dedicated plaque analysis software. The results of TPV at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy.

    3. the change of lesion length between baseline and follow-up CCTA [June 2020 to December 2021]

      After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. The length of lesion at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 1.baseline CCTA revealed at least one lesion with stenotic extent from 50% to 69% on major epicardial arteries (diameter ≧2 mm);

    • 2.patients were referred for optimal medical treatment;

    • 3.patients agreed to undergo follow-up CCTA at 1-year interval.

    Exclusion Criteria:

    • 1.patients had previous history of myocardial infarction or coronary revascularization;

    • 2.patients were contraindicated to the usage of iodine contrast media;

    • 3.image quality of baseline or follow-up CCTA was severely impaired (in presence of severe artifact, non-diagnostic);

    • 4.patients withdrew the informed consents during follow-up;

    • 5.patients experienced major adverse cardiac events during follow-up;

    • 6.patients refused to undergo follow-up CCTA;

    • 7.lost follow-up

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zibo Central Hospital Zibo Shandong China 255036

    Sponsors and Collaborators

    • Zibo Central Hospital

    Investigators

    • Principal Investigator: Bo Li, Doctor, Zibo Central Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zibo Central Hospital
    ClinicalTrials.gov Identifier:
    NCT04416425
    Other Study ID Numbers:
    • ZiboCH
    First Posted:
    Jun 4, 2020
    Last Update Posted:
    Apr 21, 2021
    Last Verified:
    May 1, 2020
    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
    Additional relevant MeSH terms:
    Atherosclerosis
    Plaque, Atherosclerotic

    Study Results

    No Results Posted as of Apr 21, 2021