Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment

Zibo Central Hospital

Status: Unknown

Conditions: Atherosclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT04416425

ZiboCH

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Enrolled Cohort

Description:

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.