Ignite Creation Date:
2024-05-06 @ 1:33 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01837823
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2013-04-05
Brief Title:
YELLOW II Study Reduction in Coronary Yellow Plaque Lipids and Vascular Inflammation by Aggressive Lipid Lowering
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
YELLOW II Study Reduction in Coronary Yellow Plaque Lipids and Vascular Inflammation by Aggressive Lipid Lowering
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronary artery disease CAD remains a leading cause of death in most countries It is well known that the reduction of cholesterol levels by statin therapy is associated with significant decreases in plaque burden REVERSAL ASTEROID and more recently the SATURN II trial showed that in patients with CAD lipid lowering with atorvastatin or rosuvastatin respectively reduced progression of coronary atherosclerosis even causing plaque regression of some lesions CAD clinical events are related to plaque instability due to lipid content and activity within the atherosclerotic plaque The investigators recently completed the YELLOW I study and identified that intensive statin therapy rosuvastatin 40mg was associated with a reduction in the amount of lipid in obstructive coronary plaques as measured by near-infrared spectroscopy NIRS The YELLOW II study is designed to expand and build upon these results and to provide mechanistic insights into the potential benefits of intensive statin therapy on atherosclerotic plaques
Detailed Description:
YELLOW II is a single site study and will assess the regression of plaque lipid content and changes in plaque morphology from atherosclerotic lesions after high-dose statin therapy by utilizing NIRS IVUS and optical coherency tomography OCT imaging modalities in the coronary arteries We propose to image non-culprit coronary lesions using these modalities in patients with two or three diseased coronary vessels deemed to warrant intervention on clinical grounds Thus at the time of enrolment patients will undergo Percutaneous Coronary Intervention PCI of a non-study culprit lesion and triple-modality imaging of the potential non-culprit YELLOW lesion If there is high baseline lipid content in the non-culprit YELLOW lesion max 4mm LCBI 150 patients will be formally entered into this study Following this all enrolled subjects will receive high-dose lipid lowering therapy rosuvastatin 40mg daily The non-culprit YELLOW lesion will undergo staged intervention 8-12 weeks following study enrolment and baseline imaging At this time the YELLOW lesion will be reimaged to determine whether high-dose statin therapy caused a reduction in lipid content as assessed by NIRS and other altered plaque morphology as assessed by OCT and IVUS In addition both at baseline and at the time of final non-culprit YELLOW lesion PCI blood samples will be drawn during baseline and follow-up procedure to characterize reverse cholesterol transport by ability of patient HDL to accept cholesterol from cholesterol-laden mouse J774 macrophage cholesterol efflux and the effect of patient HDL and apolipoprotein A1 on macrophage gene expression and migration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HS 12-00741 | None | None | None |