Tailored Antiplatelet Initiation to Lessen Outcomes due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI)
Aims: This study is looking for participants who underwent a Percutaneous coronary intervention (PCI) procedure initially presenting with either acute coronary syndrome or stable coronary artery disease. The patients will be randomized to one of two groups (with 50:50 chance): the conventional therapy group in which the patients will receive clopidogrel (Plavix) once daily with retrospective genotype analysis performed at the end of one year of treatment; and the prospective genotyping group, in which the patients will have prospective genotyping performed (via a buccal swab) to guide anti-platelet therapy.  Patients in this group who are identified to have reduced function CYP2C19 allele will receive ticagrelor (Brilinta) twice daily and patients with wild type CYP2C19 allele will receive clopidogrel (Plavix) once daily. The participants from both groups will have their genotype tested after one year from a stored blood sample drawn while at the hospital.
The purpose of this study is by using pharmacogenomics (perspective and retrospective genotyping) to determine whether choosing medication (antiplatelet therapy) based on an individual genotype will lead to better outcomes defined as a decrease in major cardiac events in patients undergoing PCI.
Participation in the study will last for 12 months with 3 follow up phone visits. The study is expected to be completed in 2016.
Diagnosis: Percutaneous coronary intervention (PCI) procedure
Principal Investigator/s: Jorge Saucedo, MD (NorthShore University HealthSytem); Naveen Pereira, MD (Mayo Clinic)
Sponsor: Mayo Clinic; Spartan Bioscience, Inc. is providing lab equipment for use in this study
Contact: Elena Genova, PhD, 847.444.5314; egenova-peeva@northshore.org and Jean Skelskey, RN, 847.570.1810; jskelskey@northshore.org
Open to Enrollment: Yes 

Evaluation of XIENCE PRIME™ or XIENCE V® versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL)
Aims: This study is looking for participants with unprotected left main coronary artery disease. The left main coronary artery is the most important blood vessel that supplies blood and nutrients to the heart. This artery sometimes becomes narrowed so that the blood flow to the heart is decreased which can cause pain or other symptoms. Coronary Artery Bypass surgery is currently the standard treatment. Recently stenting has become a treatment alternative. The purpose of this study is to see if the XIENCE PRIME™ or XIENCE V® stents are a safe and effective treatment for the narrowing of the left main artery when compared to coronary artery bypass surgery. This is a randomized trial where either treatment is equally likely to be selected (50:50 odds for either treatment). Participation in the study will last for a minimum of 5 years with at least 7 follow-up visits which will occur at NorthShore University HealthSystem.
Diagnosis:
Left Main Coronary Artery Disease
Principal Investigator/s: Ted Feldman, MD,  Paul Pearson, MD
IRB Approval Number: EH11-178
Sponsor: Abbott Vascular
Contact: Lisa Smalley, RN,  847.570.2366, lsmalley@northshore.org
Open to Enrollment: Yes 

CABANA  (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial)
Aims: This international study is enrolling subjects with symptomatic new onset or under-treated paroxysmal, persistent, or longstanding persistent AF. This is a prospective randomized (1:1) trial comparing primary drug therapy (rate and rhythm control) to catheter ablation. Subject participation can last up to 5 years with follow up at 3 and 6 months and then yearly at NorthShore University HealthSystem.
Diagnosis: Atrial Fibrillation
Principal Investigator: Westby Fisher, MD
IRB Approval Number: EH 09-503
Sponsor: National Heart Lung and Blood Institute
Contact: Kathleen Medica, RN, 847.570.1997, kmedica@northshore.org
Open to Enrollment: Yes

EVEREST II  Protocol # 0401 Continued Access Endovascular Valve Edge-to-Edge Repair Study (aka “MitraClip®  or REALISM”)
Aims: This study is a registry and patients are enrolled once they meet specific criteria using echocardiograms, a risk assessment profile and are deemed "high risk" for heart surgery. The purpose of this study is to collect additional safety and effectiveness data on the MitraClip® . Subject participation can last up to 5 years with follow up at 30days, 6 months and then yearly at NorthShore University HealthSystem.
Diagnosis: Subjects with moderate to severe or severe (3+ or 4+) mitral regurgitation who are considered high risk for cardiac surgery.
Principal Investigator: Ted E. Feldman, MD
IRB Approval Number: EH 05-062
Sponsor: Abbott Vascular
Contact: Kathleen Medica, RN, 847.570.1997, kmedica@northshore.org
Open to Enrollment: Yes 

The GORE REDUCE Study – GORE HELEX Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging Confirmed TIA in Patients witht Patent Foramen Ovale (PFO)
Aims: This research study is being offered to patients with a diagnosis of cryptogenic stroke or TIA who also have a PFO. The study's purpose is to demonstrate that antiplatelet medical management plus PFO closure with the GORE HELEX Septal Occluder reduces the risk of a recurrent stroke or image-confirmed TIA compared to antiplatelet medical management alone. This is a randomized study where eligible participants will be assigned either to 1) the treatment of percutaneous (through a vein in the groin) PFO closure with a GORE HELEX device using cardiac catheterization plus antiplatlet therapy, or to 2) antiplatelet therapy alone.
Diagnosis: Stroke or TIA of unknown origin and PFO
Principal Investigator: Ted E. Feldman, MD
IRB Approval Number: EH08-334
Sponsor: W. L. Gore and Associates
Contact: Jean Skelskey, RN,  847.570.1810 
Open to Enrollment: Yes

× Alternate Text