The Changes in Carotid Plaque Neovascularization After Elovocumab Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- The Changes in Carotid Plaque Neovascularization [June 2020 to December 2021]
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.
Other Outcome Measures
- The Changes in Carotid Plaque Size [June 2020 to December 2021]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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- 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;
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2.patients were referred for optimal medical treatment;
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3.patients agreed to undergo follow-up CEUS at half-year and 1-year interval.
Exclusion Criteria:
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1.patients had previous history of cerebral thrombosis or cerebral embolism;
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2.patients were contraindicated to the usage of contrast media;
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3.image quality of baseline or follow-up CEUS was severely impaired (in presence of severe artifact, non-diagnostic);
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4.patients withdrew the informed consents during follow-up;
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5.patients experienced major adverse cerebrovascular events during follow-up;
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6.patients refused to undergo follow-up CEUS;
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7.lost follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zibo Central Hospital | Zibo | Shandong | China | 255036 |
Sponsors and Collaborators
- Zibo Central Hospital
Investigators
- Principal Investigator: Bo Li, Zibo Central Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZiboCH1