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Clinical Research at VCS
The Cardiovascular Clinical Research program at VCS allows us to offer developing treatment options to our patients. Clinical Research Studies help pave the way for these new treatments to be made available to all patients, and advances medical knowledge in the field of Cardiovascular disease.
Each Research Study at VCS is led by one of our physicians, who serves as the Principal Investigator (PI) at our study site. Other VCS physicians may also participate in the research study as sub-investigators. Our patients are seen and cared for by a research physician while they are enrolled in a clinical study.
Participant Safety and Confidentiality
All Clinical Research Studies are actively monitored by a number of regulatory groups including the Food and Drug Administration (FDA) and local or regional Independent Review Boards (IRBs). Studies are conducted using strict protocols which define the criteria for participant selection, and detail exactly how the study is to be carried out from beginning to end. All staff who are involved in the conduct of the study protocol, including physicians and Research Coordinators, must complete study-specific training. The goal is to minimize risk and maximize safety for our study participants.
Participant identity is protected both by regulations of HIPAA (Health Insurance Portability and Accountability Act), and by the study protocols. Study participants are identified only by a study ID number which may also include their initials. The extent to which your medical information is used in the study will be explained to you in detail before you consent to participate.
For more information about participating in Clinical Research Studies, please visit the Center for Information & Study on Clinical Research Participation (CISCRP) website:
http://www.medicalhero.org/
Participating in a Clinical Study at VCS
Your physician may recommend that you be considered for a clinical study based on your medical condition, need, and/or history. However, the decision to participate in a Clinical Research Study is an important and personal one. Our Clinical Research Coordinators (RCs) are here to help you in every part of the Research Study process, starting with your informed consent. They will give you all the information about the study that you need to make this decision, and will make sure all your questions are answered to your satisfaction. If you choose to participate, our RC's will coordinate your participation throughout the entire Clinical Study process, from helping to set up your study-related appointments to keeping you informed of any new pertinent study information. Your Research Coordinator serves as your partner and advocate in a clinical study at VCS.
For more information about Clinical Research and the current studies at VCS, please contact:
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STUDIES WHICH ARE CURRENTLY ENROLLING PARTICIPANTS AT VCS:
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STUDY
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INDICATION
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DETAILS
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PFO Access
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Patent Foramen Ovale (PFO)
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Closure of the PFO using the Amplatzer® Occluder device in patients who have had 2 strokes, at least one stroke while on conventional treatment with medications. Follow up visits are at 6 and 12 months after the procedure.
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PROMISE
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Chest pain
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A 4-year study comparing 2 methods of initial diagnostic testing for patients who have chest pain that is suspicious for coronary artery disease. Patients will be randomly assigned to one type of initial diagnostic test. All subsequent testing and all treatment will be determined by their doctor. The patient will have 1 follow-up visit at 60 days and a follow-up phone call every 6 months for 2 to 4 years.
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QUAD PAS
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Heart Failure with the need for cardiac resynchronization therapy (CRT)
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The purpose of this study is to evaluate the performance of a quadrapolar implantable cardioverter-defibrillator (CRT-D) device system for cardiac resynchronization therapy over the course of 5 years. The device has received FDA approval, this study is to collect long-term follow-up data. There will be study follow-up visits every 6 months for 5 years.
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STUDIES WHICH ARE ONGOING, BUT NOT CURRENTLY ENROLLING:
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STUDY
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INDICATION
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DETAILS
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Hybrid MAZE
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Atrial fibrillation
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An observational data-collection study to evaluate the safety and efficacy of the combined epicardial / endocardial ablation procedure for the treatment of patients with atrial fibrillation (AFIB).
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ImproveIT
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High cholesterol
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A 5-year study to compare a combination drug (Ezetimibe 10mg + Simvastatin 40mg; single tablet; brand name VYTORIN®) with a single drug (Simvastatin 40 mg; brand name ZOCOR®) in the treatment of high cholesterol. Follow-up visits are every 4 months.
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OPTIMUM
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ICDs for Ventricular arrhythmias.
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An ongoing registry of patients who have a specifically programmed ICD (implantable cardioverter defibrillator) to monitor shocks delivered for life-threatening ventricular arrhythmias. Follow-up visits are every 6 months.
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