Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment

NCT04416425 | Unknown

• 1 other identifier: ZiboCH
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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(ΔCT-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

Other Outcomes (3)

• the change of minimal lumen diameter between baseline and follow-up CCTA

  June 2020 to December 2021

• the change of total plaque volume (TPV) between baseline and follow-up CCTA

  June 2020 to December 2021

• the change of lesion length between baseline and follow-up CCTA

  June 2020 to December 2021

Study Arms (1)

Enrolled Cohort

200 selected patients will be recruited, who have diagnosed with coronary atherosclerosis disease(stenotic extent from 50% to 69% on major epicardial arteries) by coronary computed tomography angiography(CCTA). Every two weeks, these patients will be treated with Elococumab Injection (1ml:140mg),ih.This therapy will last for one year.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 200 eligible coronary atherosclerosis disease patients were anticipated to include in this study.

You may qualify if:

• baseline CCTA revealed at least one lesion with stenotic extent from 50% to 69% on major epicardial arteries (diameter ≧2 mm);
• patients were referred for optimal medical treatment;
• patients agreed to undergo follow-up CCTA at 1-year interval.

You may not qualify if:

• patients had previous history of myocardial infarction or coronary revascularization;
• patients were contraindicated to the usage of iodine contrast media;
• image quality of baseline or follow-up CCTA was severely impaired (in presence of severe artifact, non-diagnostic);
• patients withdrew the informed consents during follow-up;
• patients experienced major adverse cardiac events during follow-up;
• patients refused to undergo follow-up CCTA;
• lost follow-up

Sponsors & Collaborators

• Zibo Central Hospital: lead

Study Sites (1)

Zibo Central Hospital

Zibo, Shandong, 255036, China

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bo Li, Doctor

  Zibo Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Li, Doctor

CONTACT

+86-18560292371; libosubmit@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: May 30, 2020
• First Posted: June 4, 2020
• Study Start: July 30, 2021
• Primary Completion: December 31, 2022
• Study Completion: February 27, 2023
• Last Updated: April 21, 2021

Record last verified: 2020-05

Locations

CN (1)