Atherosclerosis
Conditions
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.
Interventions
None listed
Sponsors
Zibo Central Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of lesion-specific CT-FFR | June 2020 to December 2021 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| the change of minimal lumen diameter between baseline and follow-up CCTA | June 2020 to December 2021 | After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure the minimal lumen diameter for each lesion. Minimal lumen diameter will be manually measured with a digital caliper at the narrowest level of the lesion using the crosssectional images accroding to the CCTA findings. The results of the minimal lumen diameter at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy. |
| the change of total plaque volume (TPV) between baseline and follow-up CCTA | June 2020 to December 2021 | After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure TPV for each lesion. Total plaque volume will be automatically measured using the dedicated plaque analysis software. The results of TPV at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy. |
| the change of lesion length between baseline and follow-up CCTA | June 2020 to December 2021 | After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. The length of lesion at baseline will be compared with results obtained during follow-up to examine the effects of Elovocumab Injection therapy. |
Countries
China
Contacts
Primary ContactBo Li, Doctor
Outcome results
None listed