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临床试验/NCT05984953
NCT05984953已完成不适用

Effect of Statins and Evolocumab on Peripheral Blood Mononuclear Cell Gene Expression in Patients With Coronary Artery Disease: Yellow V

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2013年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
195
试验地点
1
主要终点
Expression levels of mRNA in blood cells

研究概览

简要总结

The aim of the retrospective study is to characterize the molecular mechanisms responsible for the effect of statins and evolocumab in patients with stable coronary artery disease. The research team will retrieve and review intravascular imaging and gene expression data previously collected in the catheterization laboratory during the following time-period: 8/1/2013-4/14/2015 and 5/4/2021 - 10/28/2022.

详细描述

The researchers will use the previously collected transcriptomic and intravascular imaging data collected from subjects between 8/1/2013-4/14/2015 (statin group) and subjects who participated in YELLOW III study (evolocumab group). The analyses will allow us detect common and unique pathways for each drug. The researchers will use intravascular imaging findings (optical coherence tomography, OCT) to characterize patient's individual response to treatment as beneficial, if OCT fibrous cap thickness (FCT) increased at follow-up and develop machine-learning models to predict the individual response using baseline gene expression.

The researchers hypothesize that the analyses will uncover unique gene panels predicting beneficial response to statin and evolocumab allowing to select the best treatment approach for an individual patient. The total number of subjects will be 195. Transcriptomic profile of PBMC at baseline and follow-up will be compared between the groups to establish the common and distinctive molecular mechanisms of the effect of statins and evolocumab.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with coronary artery disease who underwent cardiac catheterization with or without PCI
  • Patients from 8/1/2013-4/14/2015 and YELLOW III with both visits available, baseline and follow-up

排除标准

  • patients from 8/1/2013-4/14/2015 and YELLOW III lost to follow-up

研究组 & 干预措施

Statin

85 patients treated with statin

干预措施: statin (Drug)

Evolocumab

110 patients treated with evolocumab in addition to statin or evolocumab alone

干预措施: statin (Drug)

Evolocumab

110 patients treated with evolocumab in addition to statin or evolocumab alone

干预措施: evolocumab (Drug)

结局指标

主要结局

Expression levels of mRNA in blood cells

时间窗: 18 month

Expression levels of mRNA in blood cells of the patients to be measured to identify the genes which are associated with a beneficial response to treatment using transcriptomic analysis of PBMC to find the key genes (biomarkers) responsible for effective therapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annapoorna Kini

Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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