Rosuvastatin and Evolocumab for Coronary Artery Disease
- Registration Number
- NCT05984953
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
- 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
- patients from 8/1/2013-4/14/2015 and YELLOW III lost to follow-up
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Statin statin 85 patients treated with statin Evolocumab statin 110 patients treated with evolocumab in addition to statin or evolocumab alone Evolocumab evolocumab 110 patients treated with evolocumab in addition to statin or evolocumab alone
- Primary Outcome Measures
Name Time Method Expression levels of mRNA in blood cells 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇺🇸New York, New York, United States