NCT04423406

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2022

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

June 6, 2020

Last Update Submit

April 19, 2021

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Changes in Carotid Plaque Size

    June 2020 to December 2021

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \. 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;
  • patients were referred for optimal medical treatment;
  • patients agreed to undergo follow-up CEUS at half-year and 1-year interval.

You may not qualify if:

  • patients had previous history of cerebral thrombosis or cerebral embolism;
  • patients were contraindicated to the usage of contrast media;
  • image quality of baseline or follow-up CEUS was severely impaired (in presence of severe artifact, non-diagnostic);
  • patients withdrew the informed consents during follow-up;
  • patients experienced major adverse cerebrovascular events during follow-up;
  • patients refused to undergo follow-up CEUS;
  • lost follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zibo Central Hospital

Zibo, Shandong, 255036, China

RECRUITING

Related Publications (1)

  • Chen J, Zhao F, Lei C, Qi T, Xue X, Meng Y, Zhang W, Zhang H, Wang J, Zhu H, Cheng C, Wang Q, Bi C, Song B, Jin C, Niu Q, An F, Li B, Huo X, Zhao Y, Li B. Effect of evolocumab on the progression of intraplaque neovascularization of the carotid based on contrast-enhanced ultrasonography (EPIC study): A prospective single-arm, open-label study. Front Pharmacol. 2023 Jan 4;13:999224. doi: 10.3389/fphar.2022.999224. eCollection 2022.

    PMID: 36686711DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Bo Li

    Zibo Central Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Li, Doctor

CONTACT

+86-18560292371libosubmit@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 9, 2020

Study Start

August 1, 2020

Primary Completion

December 31, 2021

Study Completion

February 27, 2022

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations

CN(1)