Coronary Artery Disease Clinical Trials
Cedars-Sinai Heart Institute is currently conducting the following coronary artery disease clinical trials:
The AWARE Study: Angiogenesis in women with Angina Pectoris who are not candidates for REvascularization
Principal Investigator: P.K. Shah, MD
IRB Approval Number: 11440
Contact: Linn Defensor, RN (310) 423-6152
Recruiting
Summary: The purpose of this study is to determine the safety and effectiveness of an investigational gene therapy product called Ad5FGF-4. The gene therapy product Ad5FGF-4 consists of a human adenovirus (a virus very similar to the virus that causes the common cold) containing the human gene for fibroblast growth factor-4 (FGF-4). The virus has been modified so that it is replication deficient (it cannot divide or reproduce , and thus should not cause an infection. This is a randomized, double-blind, placebo-controlled, parallel group Phase 3 study in approximately 300 female patients with angina (chest pain) who are not candidates for surgical intervention.
Magnetocardiography (MCG) in Subjects undergoing CT angiography (CTA)
Principal Investigator: Kirsten Tolstrup, MD
IRB Approval Number: 10057
Contact: David Gallegos, RN (310) 423-4993
Recruiting
Summary: This study uses a magnetocardiography (MCG), a safe, FDA approved, non-invasive heart scan to examine the magnetic field patterns as they relate to any heart blockages identified by a CT angiogram. Study procedures also include a 12 lead electrocardiogram and blood pressure measurement. Patient undergoing CT angiography for evaluation of their possible symptoms of heart disease maybe enrolled.
Effects of Traditional Acupuncture on Mechanisms of CHD
Principal Investigator: C. Noel Bairey Merz, MD
IRB Approval Number: 7320
Contact: Joan Kirschner, RN (310) 423-9666
Recruiting
Summary: The purpose of this study is to determine whether complementary medicine practice of traditional acupuncture versus an alternative intervention can serve as an additive/alternative treatment for the prevention of acute cardiac events in coronary heart disease patients. It will also investigate 1) arterial vasomotor dysfunction (ability of the brachial artery to expand under stress); 2) autonomic nervous system imbalance (measure beat-to-beat time variations of the heart); and the secondary outcomes of: 3) inflammatory marker (high-sensitivity C reactive protein) and 4) psychological stress and quality of life. Patients with coronary artery disease as evidenced by a history of coronary artery bypass graft, percutaneous coronary intervention, stroke and angiographic evidence of coronary artery stenosis in at least one coronary artery are eligible to participate.
CHAMPION PLATFORM: A Clinical Trial Comparing Treatment with Cangrelor (in Combination with Usual Care) to Usual Care, in Subjects Who Require Percutaneous Coronary Intervention
Principal Investigator: Bruce Samuels, MD
IRB Approval Number: 11514
Contact: MIchelle Domingo (310) 423-3875
Recruiting
Summary: Coronary artery bypass graft (CABG) has been the recommended therapy for patients with diabetes and blockages in more than one coronary artery. The implantation of a drug eluting stent has, however, been shown to be an effective treatment for patients with single vessel disease. Whether it is an effective treatment option for patients with multivessel coronary artery disease who will need two or more stents implanted is not known, and is the subject of this study. The goal of this study is to find out which of two different methods of treatment: CABG or the implantation of drug-eluting stents, is best for patients who have both diabetes and multivessel coronary artery disease. Eligible patients should have a diagnosis of Diabetes Mellitus (Type 1 or Type 2), angiographically confirmed multivessel CAD [critical (> 70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)] and amenable to either PCI or CABG.
Magnetocardiography in Chest Pain Syndrome
Principal Investigator: Kristen Tolstrup, MD
IRB Approval Number: 4039
Contact: David Gallegos, RN (310) 423-4993
Recruiting
Summary: This study involves using a safe, FDA approved, non-invasive heart scan (MCG) to detect changes in the magnetic field patterns that maybe associated with the presence of coronary disease. Patients having stable chest pain at rest or with activity who are undergoing standard heart tests such as a nuclear heart scan or angiogram maybe enrolled. The study procedures also include a 12 lead electrocardiograph and blood pressure measurement. A 6 month telephone follow-up is included.
REVASCULARIZE: Revascularization Comparing Surgery Versus Percutaneous Coronary Intervention for Left Main Artery Stenosis Randmized Evaluation Trial
Principal Investigator: Rajendra Makkar, MD
IRB Approval Number: 4426
Contact: Mitch Gheorghiu (310) 423-6152
Recruiting
Summary: The objective of the study is to demonstrate that using angioplasty as a method of treatment for left main coronary artery narrowing is not statistically inferior to the gold standard open heart bypass surgery. The study population includes patients with angiographic evidence of significant narrowing of the left coronary artery. The primary end point is major adverse cardiac and cerebrovascular events at 1 year post interventional procedure. The clinical findings and other adverse events during the procedure are considered as secondary endpoints.
REVITALIZE: Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction
Principal Investigator: Rajendra Makkar, MD
IRB Approval Number: 4441
Contact: Michelle Domingo (310) 423-3875
Recruiting
Summary: Patients who have suffered a heart attack and undergone angioplasty and stent placement in the past 10 days may be eligible to participate in a study using their own stem cells as a potential therapy in heart muscle repair. The use of a patient¿s own bone-marrow derived stem cells may avoid the ethical and rejection issues associated with other types of stem cells. To qualify, patients must have evidence of decreased heart muscle function. Those who participate will have cardiac MRI testing and other non-invasive evaluations and lab work at scheduled intervals up to a year. The stem cell treatment is a two-step, non-surgical procedure. First, patients will be given a local anesthesia and cells will be removed from the bone marrow. Stem cells will then be isolated and injected into the coronary artery responsible for the heart attack.
JOSTENT: Graftmaster Coronary Stent for Commercial Use in Selected Patients Through a Humanitarian Device Exemption (HDE)
Principal Investigator: Rajendra Makkar, MD
IRB Approval Number: 4195
Contact: Michelle Domingo (310) 423-3875
Recruiting
Summary: Patients undergoing coronary angiography and who have a procedural complication of a perforation in their coronary artery can receive a JOSTENT® Coronary Stent Graft. The JOSTENT® is a device which can close perforations in coronary arteries. A perforation is a hole in the coronary artery wall. Blood that feeds the heart muscle escapes through this hole and starts to fill up the sac that surrounds the heart. A perforation can be life threatening. These perforations are rare, but are a potential complication of coronary angiography. If this occurs, a JOSTENT® Coronary Stent Graft can be used in this life threatening situation. The purpose of the study is to evaluate the technical success and safety of the JOSTENT Coronary Stent Graft as a life-saving treatment in cases of coronary artery perforation.
Prognostic Significance of Circulating Endothelial Progenitor Cells (EPCs) in Patients Undergoing Primary Coronary Intervention with Drug Eluting Stent
Principal Investigator: Rajendra Makkar, MD
IRB Approval Number: 8711
Contact: Michelle Domingo (310) 423-3875
Recruiting
Summary: EPCs (endothelial progenitor cells) are a type of circulating stem cell in our blood that are thought to assist in repair of the blood vessel wall. Monocytes are another type of circulating blood cell (part of the immune system). A variable number of the monocytes have a protein called Toll-like Receptor 4 (TLR4) on their surface. In this study we will measure both of these types of cell (EPC and monocytes with TLR4) then test if there is any relationship between the number of either of these cells and patient prognosis after undergoing implantation of a coronary stent.
Cedars-Sinai Drug-Eluting Stent (CDES) Registry
Principal Investigator: Rajendra Makkar, MD
IRB Approval Number: 8660
Contact: Michelle Domingo (310) 423-3875
Recruiting
Summary: This study attempts to provide more information on patients who receive DES (drug eluting stents) by creating a database of health information. The goals of stenting are to reduce chest pain and improve quality of life and possibly increase lifespan. Stent implantation reduced the frequency of reblockage 20% to 30%. DES have further reduced reblockage to <10%, with repeat stenting being performed in approximately 5% of patients. Death, heart attack, and repeat stenting during the first 2 years after stenting have been shown to be reduced significantly in patients receiving DES compared with bare metal stents.
Protect 1: A Clinical Trial Investigating the Use of the IMPELLA ® RECOVER LP 2.5 System, A Circulatory Assist Device in Patients Undergoing High Risk PC
Principal Investigator: Rajendra Makkar, MD
IRB Approval Number: 10204
Contact: Michelle Domingo (310) 423-3875
Recruiting
Summary: The objective of the study is to determine if the IMPELLA® RECOVER® LP 2.5 System is safe and potentially effective for patients undergoing high risk PCI (percutaneous coronary intervention). This investigational device pumps up to 2.5 L/min of blood from the left ventricle to systemic circulation and therefore assists the patient's heart to circulate blood throughout their body.
