The Changes in Carotid Plaque Neovascularization After Elovocumab Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Diseases

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Bo Li, Doctor; Phone Number: +86-18560292371; Email: libosubmit@163.com

Study Locations

• China
  • Shandong
    • Zibo, Shandong, China, 255036
      • Recruiting
      • Zibo central Hospital
      • Contact: Bo Li, doctor; Phone Number: 86-18560292371; Email: libodoc@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 150 eligible coronary atherosclerosis disease patients were anticipated to include in this study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): February 27, 2022

Study Registration Dates

• First Submitted: June 6, 2020
• First Submitted That Met QC Criteria: June 6, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metaplasia; Neovascularization, Pathologic; Carotid Artery Diseases
• Other Study ID Numbers: ZiboCH1

Drug and device information, study documents

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