Medical Student Research Fellowship for Summer 2009

Mentor: Emmanouil Brilakis, MD, PhD
Department: Cardiology
Room number: VA, Cardiac Cath Lab
Mail Code: 111A
Phone number: 214-857-1547
E-mail: esbrilakis@yahoo.com

Project I title: Correlation of Intravascular Ultrasonography Virtual Histology with Patients' Baseline Clinical Characteristics and Clinical Outcome

Human subjects IRB approved project number (where applicable): pending

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.

Project II title: The SOS (Stenting Of Saphenous vein grafts randomized-controlled trial)

Human subjects IRB approved project number (where applicable): 05-026

Animal subjects IRB approved project number (where applicable): NA

Project Type patient-based research

Brief Description of Project:

The SOS is a prospective, multicenter, randomized-controlled study that will randomize 80 consecutive patients undergoing stenting of a de novo or restenotic saphenous vein graft lesion in a 1:1 ratio to the uncoated Express2 stent or the identical design Taxus paclitaxel-eluting stent in order to determine:

(1) whether the Taxus paclitaxel-eluting stent will reduce the incidence of binary angiographic in-stent restenosis as assessed by 12-month follow-up quantitative coronary angiography (primary study endpoint), and

(2) whether the Taxus paclitaxel-eluting stent will achieve the following secondary study endpoints:
(a) reduce intra-stent intimal hyperplasia volume accumulation at 12-months, as measured by intravascular ultrasound
(b) reduce the 24-month incidence of:
" ischemia-driven target vessel revascularization
" target vessel failure, and
" overall major adverse cardiac and cerebrovascular events

The results of the study were recently published (Brilakis ES, Lichtenwalter C, de Lemos JA, Roesle M, Obel O, Haagen D, Saeed B, Gadiparthi C, Bissett JK, Voudris VV, Karyofillis P, Kar B, Rossen J, Fasseas P, Berger PB, Banerjee S. A Randomized-Controlled Trial Of A Paclitaxel-Eluting Stent vs. A Similar Bare Metal Stent In Saphenous Vein Graft Lesions. The SOS (Stenting Of Saphenous Vein Grafts) Trial. J Am Coll Cardiol:published online before print.

Substudies of SOS (long-term patient follow-up, evaluation of additional patients receiving novel DES, etc) are ongoing.

Previous Research Activities or Publications with Medical Students:

1. Boatman D, Saeed B, Varghese I, Peters CT, Daye J, Peters Haider A, Roesle M, Banerjee S, Brilakis ES. Prior coronary artery bypass graft surgery patients undergoing diagnostic coronary angiography have multiple uncontrolled coronary artery disease risk factors and high risk for cardiovascular events. Heart Vessels; in press

2. Daye J, Boatman D, Peters C, Varghese I, Haider A, Roesle M, Jessen ME, DiMaio JM, Banerjee S, Brilakis ES. Perioperative Risk of Patients Undergoing Noncardiac Surgery After Coronary Artery Bypass Surgery. J Investig Med 2008;56:878-881

3. Varghese I, Boatman DM, Peters CT, Daye J, Haider A, Roesle M, Banerjee S, Brilakis ES. Impact on Contrast, Fluoroscopy, and Catheter Utilization From Knowing the Coronary Artery Bypass Graft Anatomy Before Diagnostic Coronary Angiography. Am J Cardiol 2008; 101:1729-1732