Viewing Study NCT04710368



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Last Modification Date: 2024-10-26 @ 1:54 PM
Study NCT ID: NCT04710368
Status: COMPLETED
Last Update Posted: 2023-11-18
First Post: 2021-01-12

Brief Title: Effect of Evolocumab on Coronary Plaque Characteristics
Sponsor: Annapoorna Kini
Organization: Icahn School of Medicine at Mount Sinai

Study Overview

Official Title: Effect of Evolocumab on Coronary Plaque Characteristics a Multimodality Imaging Study
Status: COMPLETED
Status Verified Date: 2023-11
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: YELLOW III
Brief Summary: The aim of the study is to assess the effect of evolocumab on coronary plaque morphology using intravascular imaging and gene expression analysis of peripheral blood mononuclear cells PBMC in patients with stable CAD on maximally tolerated statin therapy The study combines multi-modality intravascular imaging approaches and transcriptomic based machine learning algorithms to uncover molecular mechanisms responsible for the beneficial changes in atherosclerotic lesions of patients treated with evolocumab The primary end-points are the changes from baseline to follow-up in 1 the minimal fibrous cap thickness FCT assessed by optical coherence tomography OCT and 2 maxLCBI4mm assessed by near-infrared spectroscopy NIRS after 26 weeks of evolocumab The secondary endpoints are the changes in 1 the maximal lipid arc lipid length lipid volume index macrophage accumulation and calcification by OCT 2 PAV and TAV defined by intravascular ultrasound IVUS and 3 Changes in PBMC gene expression
Detailed Description: The single center single arm study will be performed in the Cardiac Catheterization laboratory of the Mount Sinai Hospital New York NY After informed consent patients undergoing clinically indicated elective PCI with a non-obstructive lesion and optimal background statin therapy will be eligible screening Non-obstructive lesions 30-50 stenosis identified by angiography in a non-culprit vessel with lipid-rich plaque will be studied Subjects will receive evolocumab Repatha 140 mg subcutaneously every 2 weeks for 26 weeks Serial NIRSIVUS and OCT imaging will be performed in the non-obstructive lesions first during PCI and subsequently after 26 weeks A total of 25ml of blood will be drawn from the sheath during angiography for transcriptomic profiling of PBMC

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None