Mount Sinai Hospital
New York, 10029, United States
NCT Number: NCT05984953
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.
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Notify Me18 year and older
All sexes
Observational
New York, 10029, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
40 mg of rosuvastatin daily for 8-12 weeks
140 mg evolocumab every 2 weeks (26 weeks)
Time frame: 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.
Icahn School of Medicine at Mount Sinai
Other
Effect of Statins and Evolocumab on Peripheral Blood Mononuclear Cell Gene Expression in Patients With Coronary Artery Disease: Yellow V
Acronym: Yellow V
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