Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment

NCT ID: NCT04416425

Last Updated: 2021-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-30

Study Completion Date

2023-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 1.patients had previous history of myocardial infarction or coronary revascularization;
* 2.patients were contraindicated to the usage of iodine contrast media;
* 3.image quality of baseline or follow-up CCTA was severely impaired (in presence of severe artifact, non-diagnostic);
* 4.patients withdrew the informed consents during follow-up;
* 5.patients experienced major adverse cardiac events during follow-up;
* 6.patients refused to undergo follow-up CCTA;
* 7.lost follow-up
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zibo Central Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bo Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zibo Central Hospital

Locations

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Zibo Central Hospital

Zibo, Shandong, China

Site Status

Countries

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China

Central Contacts

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Bo Li, Doctor

Role: CONTACT

+86-18560292371

Facility Contacts

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Bo Li

Role: primary

Other Identifiers

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ZiboCH

Identifier Type: -

Identifier Source: org_study_id

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