Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment

• Conditions: Atherosclerosis

• Registration Number: NCT04416425
• Lead Sponsor: Zibo Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-30
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-21
• Study Start: 2021-07-30
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Zibo Central Hospital; 🇨🇳 Zibo, Shandong, China