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Research

As a leader in cardiovascular research for more than 15 years, Covenant Heart Institute doctors have gained national recognition for treatment of patients with heart disease using cutting-edge drugs and devices. Cardiovascular research has been vital to the mission of Covenant Heart Institute

Research done at Covenant Heart Institute involves clinical trials that are used to test the safety and effectiveness of drugs and medical procedures. Research is a partnership between physician investigators and study volunteers, and helps set the standards for patient care. There are potential benefits for clinical trial patients. By participating in a clinical trial, patients can play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research. In addition, our investigators are also practicing physician, and see first-hand the impact of the research that is done at our institution.

Every clinical trial in the must be approved and monitored by an Institutional Review Board (IRB). An IRB is an independent committee of physicians, statisticians, community advocates, and others whose purpose is to ensure that a clinical trial is ethical and the rights of study patients are protected. The Covenant Health System IRB includes nurses, attorneys and community representatives. The IRB also reviews the proposed clinical trial protocol to make sure that the risks involved in participating in a trial are significantly outweighed by the potential benefits. Federal law mandates that all institutions that conducting research involving people must have an IRB that initially approves and periodically reviews the research projects.

Federal regulations and policies protect patients in clinical research trials, ensuring that their safety is given the highest priority. Proper performance of research consent and oversight procedures makes demands on the time of already-busy clinical researchers.

If you have questions about your rights as a research subject, you can contact the Covenant Health System IRB office at 806-725-1504.

Covenant Heart Institute is currently participating in a number of global clinical trials including:

Pacing Evaluation – Atrial Support Study in Cardiac Resynchronization Therapy – PEGASUS CRT, GUIDANT Corporation

 

Protocol #H7T-MC-TAAL: A Comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Patients who are to Undergo Percutaneous Coronary Intervention – TRITON-TIMI 38, Eli Lilly and Company, Sankyo Company Limited, Japan – Phase III

 

Protocol #P04103: IMProved Reduction of Outcomes:  Vytorin Efficacy International Trial (IMPROVE IT) A Multicenter, Double Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (ezetimibe/simvastatin) vs. Simvastatin Monotherapy in High Risk Patients Presenting with Acute Coronary Syndrome, Merck/Schering-Plough Pharmaceuticals the developer of Vytorinâ, and Merck & Co. – Phase IV

 

Protocol #20050222: A Double-blind, Randomized Placebo-controlled, Multicenter study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia – RED HF Trial, Amgen, Inc. – Phase III

 

Protocol #EFC5965: CURRENT / OASIS 7 - Clopidogrel optimal loading dose Usage to Reduce Recurrent EveNTs/ Optimal Antiplatelet Strategy for InterventionS - Randomized, multinational, double-blind study, comparing a high loading dose regimen of clopidogrel versus standard dose in patients with unstable angina or non-ST segment elevation myocardial infarction managed with an early invasive strategy – Sanofi-Aventis – Phase III

 

Protocol # D5130C05262: A Randomized, Double-blind, Parallel Group, Phase Efficacy and Safety of AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary Syndromes (ACS) – PLATO Trial – AstraZeneca – Phase III

 

Protocol #TMC-CAN-05-02: A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention – CHAMPION PCI – The Medicines Company – Phase III

 

Protocol # A3191172: A Randomized, Double Blind, Parallel-Group Study of Cardiovascular Safety In Osteoarthritis or Rheumatoid Arthritis Patients With or at High Risk for Cardiovascular Disease Comparing Celecoxib With Naproxen and Ibuprofen – PRECISION Trial – Pfizer and Cleveland Clinic Cardiovascular Coordinator Center – Phase IV

Our department is run under the direction of Dr. David Jinich. If you have any questions about our clinical trials, please contact the Covenant Heart Institute Research Coordinators Deenie Stone, BSN, CCRC at 806-725-1824 or Melanie Swanson, MS, CCRC at 806-725-1823.  They will be happy to answer all of your questions, and let you know if you are eligible for any of our clinical research trials.

At Covenant Heart Institute, we know that you are counting on us to provide premiere cardiovascular care and that is why we are dedicated to participating in international trials that will provide our patients with cutting edge medicine and devices.

 


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