The Changes in Carotid Plaque Neovascularization After Elovocumab Therapy

Carotid Artery Diseases Clinical Trial

Official title:

The Changes in Carotid Plaque Neovascularization After Long-term Elovocumab Injection Therapy: A Follow-Up Study by Contrast Enhanced Ultrasonography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423406
• Other study ID #: ZiboCH1
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: February 27, 2022

Study information

• Verified date: April 2021
• 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

150 selected patients will be recruited, who have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography. For each of the plaques, standard ultrasonography will be used to evaluate lesion echogenicity, while contrast-enhanced ultrasonography (CEUS) will be used to perform the visual and quantitative analysis of neovascularization. Each technique will be applied at baseline (at the time of study enrollment) and following 0.5、1 year of Elococumab Injection treatment. During the study, these patients will be treated with Elococumab Injection (1ml:140mg),ih, every two weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 27, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 1. have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography;

• 2.patients were referred for optimal medical treatment;

• 3.patients agreed to undergo follow-up CEUS at half-year and 1-year interval.

Exclusion Criteria:

• 1.patients had previous history of cerebral thrombosis or cerebral embolism;

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

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

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

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

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

• 7.lost follow-up

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Neovascularization, Pathologic

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 Changes in Carotid Plaque Size	After one year's treatment of Elovocumab Injection, the patients will undergo follow-up standard ultrasonography again. We will measure the size of each lesion.The carotid plaque sizes at pre- and post-elovocumab therapy will be analysed.	June 2020 to December 2021
Primary	The Changes in Carotid Plaque Neovascularization	We will use the time-signal intensity curve to calculate the changes in carotid plaque neovascularization.The time-intensity curve parameters includes: Baseline intensity(BI) and peak intensity (PI).Due to the ultrasound contrast agent, the intra-plaque signal intensity increased. Thus, enhanced intensity (EI) was calculated as follows: EI = PI - BI. EI is a parameter that measures the intensity differences between pre- and post-injections of the intravascular tracer. Relative plaque enhancement (EI-R), measured at the separate peak enhancement point in the blood and plaque, will be calculated as the ratio of enhanced intensity in the carotid artery lumen (EI-L) to the enhanced intensity in the plaque (EI-P) using the following formula: EI-R=EI-L/EI-P.	June 2020 to December 2021