Request for Funding
Medical Student Research Fellowship for Summer 2011
All descriptions must contain enough detail to permit an assessment of the problem that is to be addressed and the methodologies that are to be employed. Please be careful to outline the role that the student will play in the project that is described. Please ensure that all relevant approval numbers (IRB, IACUC) are provided.
Mentor: Emmanouil S. Brilakis, MD, PhD
Room number: VA 5B-670
Mail Code: 111A
Phone number: 214-857-1547
E-mail: email@example.com – Emmanouil.firstname.lastname@example.org
Project #1 title: Prospective Evaluation of the Xience V Everolimus-Eluting Stent In Saphenous Vein Graft Atherosclerosis: The Xience V-SVG Angiographic Study
Human subjects IRB approved project number (where applicable): 09-016
Project Type patient-based research
Brief Description of Project:
Implantation of bare metal coronary stents (BMS) is currently the preferred percutaneous treatment for aortocoronary saphenous vein bypass graft (SVG) lesions, but is associated with high risk for in-stent restenosis. Although drug-eluting stents (DES) appear promising, there are limited and conflicting data on their efficacy and safety in SVGs. Our group recently completed and reported the angiographic follow-up of the SOS (Stenting Of Saphenous vein grafts) trial that compared a paclitaxel-eluting stent with a similar BMS. There is currently no data on the use of the second generation DES in these challenging lesions. We propose a pilot study to examine the effects of the Xience V everolimus-eluting stent in SVG lesions.
The specific aim of this proposal is to examine the 12-month incidence of binary angiographic in-stent restenosis (defined as a stenosis of >50% of the minimum lumen diameter of the target segment) after implantation of the Xience V stent in SVG lesions.
The Xience V stent will be implanted in 40 consecutive patients who need stenting of a SVG lesion. Patients will undergo repeat follow-up angiography and intravascular ultrasonography at 12 months and will be followed clinically for 12 months to determine:
(1) the incidence of binary angiographic in-stent restenosis, as assessed by 12 month follow-up quantitative coronary angiography (primary study endpoint), and
(2) intra-stent intimal hyperplasia volume accumulation at 12 months, as measured by intravascular ultrasonography, and (b) 12-month incidence of ischemia-driven target vessel revascularization, stent thrombosis, and target vessel failure (composite of cardiac death, myocardial infarction, and target vessel revascularization) (secondary study endpoints).
Project #2 title: Correlation of Intravascular Ultrasonography Virtual Histology with Patients’ Baseline Clinical Characteristics and Clinical Outcome
Human subjects IRB approved project number (where applicable): 09-021
Animal subjects IRB approved project number (where applicable): NA
Project Type patient-based research
Brief Description of Project
This study will retrospectively evaluate the correlation between the post-processed Virtual Histology (VH) of Intravascular Ultrasonography (IVUS) and patient’s baseline clinical characteristics and subsequent clinical outcomes. This study is a retrospective, multi-center, non-randomized analysis of correlation between IVUS-VH data and patient clinical characteristics and subsequent clinical events at the follow-up.
Primary end point of the study is time from index IVUS procedure to clinical follow-up events such as myocardial infarction, revascularization, and death. Secondary endpoint is correlation of IVUS-VH findings with baseline demographics.
Previous Research Activities or Publications with Medical Students: