Coronary Artery DiseaseYellow VNCT05984953
Rosuvastatin and Evolocumab for Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- statin and evolocumab
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2013to 28 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with coronary artery disease who underwent cardiac catheterization with or without PCI
Who may be able to join
- 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
Who cannot join
- patients from 8/1/2013-4/14/2015 and YELLOW III lost to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Statins and Evolocumab on Peripheral Blood Mononuclear Cell Gene Expression in Patients With Coronary Artery Disease: Yellow V
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- statin, evolocumab
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
statinDrug
40 mg of rosuvastatin daily for 8-12 weeks
evolocumabDrug
140 mg evolocumab every 2 weeks (26 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Statin | 85 patients treated with statin Receives: Drug: statin | |
| Evolocumab | 110 patients treated with evolocumab in addition to statin or evolocumab alone Receives: Drug: statin; Drug: evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of mRNA in blood cells
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.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Aug 2013
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annapoorna Kini, Icahn School of Medicine at Mount Sinai
- Investigators
- Annapoorna Kini, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984953
- Sponsor's protocol ID
- STUDY-22-01743
- Acronym
- Yellow V
- Status last verified
- Aug 2023
- First submitted
- 5 Apr 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statins and Evolocumab on Peripheral Blood Mononuclear Cell Gene Expression in Patients With Coronary Artery Disease: Yellow V
- ClinicalTrials.gov ID
- NCT05984953
- Acronym / sponsor ID
- Yellow V / STUDY-22-01743
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin | – | Drug: statin85 patients treated with statin |
| Evolocumab | – | Drug: statin, Drug: evolocumab110 patients treated with evolocumab in addition to statin or evolocumab alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with coronary artery disease who underwent cardiac catheterization with or without PCI
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- patients from 8/1/2013-4/14/2015 and YELLOW III lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| statin40 mg of rosuvastatin daily for 8-12 weeks | Drug | Evolocumab, Statin |
| evolocumab140 mg evolocumab every 2 weeks (26 weeks) | Drug | Evolocumab |
Primary outcome
Expression levels of mRNA in blood cells
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annapoorna Kini, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of mRNA in blood cells (time frame: 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.