Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment

Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment: A Serial Follow-Up Study by Computed Tomography-Derived Fractional Flow Reserve

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.

Study Overview

• Status: Unknown
• Conditions: Atherosclerosis

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Shandong
    • Zibo, Shandong, China, 255036
      • Zibo Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 200 eligible coronary atherosclerosis disease patients were anticipated to include in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of lesion-specific CT-FFR	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.	June 2020 to December 2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of minimal lumen diameter between baseline and follow-up CCTA	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.	June 2020 to December 2021
the change of total plaque volume (TPV) between baseline and follow-up CCTA	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.	June 2020 to December 2021
the change of lesion length between baseline and follow-up CCTA	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.	June 2020 to December 2021

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): July 30, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): February 27, 2023

Study Registration Dates

• First Submitted: May 30, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Atherosclerosis; Plaque, Atherosclerotic
• Other Study ID Numbers: ZiboCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No