Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04416425
• Other study ID #: ZiboCH
• Status: Not yet recruiting
• Start date: July 30, 2021
• Est. completion date: February 27, 2023

Study information

• Verified date: May 2020
• Source: Zibo Central Hospital
• Contact: Bo Li, Doctor
• Phone: +86-18560292371
• Email: libosubmit[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 27, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Plaque, Atherosclerotic

Locations

Country	Name	City	State
China	Zibo Central Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Zibo Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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(?CT-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