OCIS-Coordinated Studies


List of Studies Open to Enrollment

 

Study Short Name:  BRIDGE
Indication:  Atrial Thromboembolic Events, Atrial Fibrillation
Purpose:   Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk of a stroke or heart attack. When people undergo surgery or certain procedures, they must stop using warfarin to prevent too much bleeding during and after the surgery or procedure. Some doctors prescribe a different blood thinner, one that works more quickly and wears off more quickly, to bridge the gap between starting and stopping warfarin. However, this short-term treatment is expensive, may increase the risk of bleeding, and has not been proven effective. This study will determine whether a bridging blood thinner called dalteparin is helpful or harmful for people with atrial fibrillation who stop taking warfarin in preparation for surgery or a procedure.
Subject Participation: To be eligible, subjects must be currently receiving treatment with warfarin for atrial fibrillation or atrial flutter and have a planned surgery or procedure requiring a temporary stop of warfarin therapy. About 3,626 subjects in the United States and Canada will be asked to participate in this study, Augusta University plans to enroll 60 subjects over a period of two years. Participation in this study will last between 36 and 67 days. Participation will involve nine points of contact with researchers, at least two of which will be in-person visits at the research clinic. The others will be conducted by phone. Participants will self-administer a subcutaneous injection of their assigned treatment twice a day for 3 days before the surgery or procedure and for 6 days after. During the course of the study, when participants visit their primary physicians for regularly scheduled appointments, it will be recommended that they undergo two international normalized ratio (INR) tests of blood clotting ability between day 2 and 10 after the surgery or procedure. The remaining seven points of contact will occur sometime between the day before surgery and 37 days after surgery. One of the in-person visits will occur within the first week after surgery and will include assessments on possible bleeding, any new symptoms, and INR results.
Subject Compensation:  The study sponsor is paying for procedures being done solely for the study. Subjects are responsible for all co-pays and standard of care treatment. Subjects will receive compensation for study participation.
Clinicaltrials.gov identifier: NCT00786474
Principal Investigator: Jaspal Gujral, MBBS
For More Information, Contact: Peggy Best, RN, at 706-721-9546 (pbest@augusta.edu

 

Study Short Name:  COAG
Indication:  Stroke, Venous Thrombosis, Atrial Fibrillation, Atrial Flutter
Purpose:   Individuals taking warfarin often need frequent dose changes as the INR gets too high or too low which could result in a higher risk of thromboembolism, bleeding and early discontinuation of a highly useful therapy. This study will compare two approaches to warfarin dosing to examine the utility of using genetic information for warfarin dosing.
Subject Participation: To be included in the study, the participant's doctor must recommend the patient begin taking the medication warfarin for at least one month.  Subjects who meet the inclusion/exclusion criteria are eligible to participate in the study and may receive a different dose of warfarin than another person. Some of these differences are due to differences in age, race, sex, weight, and medical conditions.  Genetic information will be collected to help doctors find the dose of warfarin that participants may need. Study participation will last for 6 months.
Subject Compensation:  The study plans to enroll 1,238 participants from about 18 medical centers in the United States. About 45 subjects may participate in this registry at Augusta University and/or GRMC.
Clinicaltrials.gov identifier: NCT00839657
Principal Investigator: Jaspal Gujral, MBBS
For More Information, Contact: Peggy Best, RN, at 706-721-9546 (pbest@augusta.edu

 

Study Short Name:  IPAC
Indication:  Cardiomyopathy Pregnancy
Purpose:  

In an observational study, subjects may be required to donate a blood specimen or undergo a diagnostic procedure, no treatment will be administered to them to try to change the course of their condition.  In this type of study, data will be collected from the subjects through clinical testing or questionnaires.

Peripartum cardiomyopathy is a heart muscle weakness that occurs during or following pregnancy. Research suggests that many initial heart injuries including viruses, pregnancy and other unknown causes, can lead to a process of inflammation of the heart muscle which can weaken the heart and cause cardiomyopathy. Why this process occurs in women during pregnancy is not well understood and if it differs from those women who develop cardiomyopathy from a virus is unknown. This study has been proposed to look at genetic information (DNA) as well as the immune system (the body's response to fight off infections and/or viruses) to find possible causes for the heart muscle damage that occurs in peripartum cardiomyopathy.

Subject Participation: Approximately 100 women with peripartum cardiomyopathy after delivery, ages 16 and older, will be enrolled in this study at approximately 30 different sites.  Georgia Health Science University plans to enroll 7-8 participants.   Eligible subjects who agree to participate will have a total of no more than four visits:  Baseline, 2 months, 6 months and 12 months after delivery.  Assessments include genetic and laboratory blood samples, questionnaires, echocardiogram, and optional MRI.
Subject Compensation:  The study sponsor is paying for procedures being done solely for the study. Subjects are responsible for all co-pays and standard of care treatment.  Subjects will not receive compensation for study participation.
Clinicaltrials.gov identifier: NCT01085955
Principal Investigator: John W. Thornton, III, MD
For More Information, Contact: Myrna Mattos, RN, at 706-721-9683 (mmattos@augusta.edu

 

Study Short Name:  Maravoric
Indication:  HIV-1 Infected, Maravoric-experienced
Purpose:  

This is a Non-Interventional study.  A non-interventional study is a study in which drugs are prescribed per their locally approved label indication and therapies given as part of normal clinical practice.

The purposes of this study is to find out if the use of Maraviroc, along with an optimized background regimen of antiretroviral drugs in usual clinical practice, is as safe as using only an optimized regimen of antiretroviral drugs.

Subject Participation: This study does not require additional visits or tests.  Data from the subject’s regular doctor visits and medical history, as well as any tests that are conducted as part of your standard care, will be collected for up to 5 years. 
Subject Compensation:  Subjects will receive compensation for participation in the study. 
Clinicaltrials.gov identifier: NCT00665561
Principal Investigator: J. Peter Rissing, MD
For More Information, Contact: Myrna Mattos, RN, at 706-721-9683 (mmattos@augusta.edu

 

Study Short Name:  RAID
Indication:  Ischemic Cardiomyopathy
Purpose:   The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators (ICDs). This drug will be used with standard medications that are routinely prescribed in enrolled patients.
Subject Participation: To be eligible to participate, patients must recently had, or need to have, an implantable cardioverter defibrillator (ICD) implanted to treat irregular heart beat rhythm (cardiac arrhythmia). Ranolazine (known as Ranexa) has been approved by the United States Food and Drug Administration (FDA) for the treatment of patients with heart disease. It has not been approved for the prevention and treatment of irregular heart beat rhythm. Ranolazine may improve the heart beat rhythm, and the level of oxygen in cells that are not receiving enough oxygen, which happens in patients with heart disease. Its use in this study is for testing purposes only. The trial will enroll 1,440 patients from 80 enrolling centers over a period of 24-27 months. The Augusta University and/or GRMC plan to enroll 1-2 patients per month, for a total of 18 and no more than 25 participants. Enrolled participants will have follow-up visits for up to 54 months. The first visits will be scheduled 1 week and 2 weeks after study drug initiation and subsequent visits will be scheduled every 3 months. All subject visits with take place in GRMC clinics.
Subject Compensation:  The study sponsor is paying for procedures being done solely for the study. Study participants are responsible for all co-pays and standard of care treatment. Participants will not receive compensation for study participation.
Clinicaltrials.gov identifier: NCT01327547
Principal Investigator: Robert Sorrentino, MD
For More Information, Contact: Myrna Mattos, RN, at 706-721-9683 (mmattos@augusta.edu

 

Study Short Name:  PROMISE
Indication:  New Chest Pain
Purpose:   A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.
Subject Participation: To participate, subjects must be 45 years of age or older and  infected with HIV, have symptoms that may be from heart disease without known coronary artery disease (CAD) for whom a nonemergent, noninvasive cardiovascular diagnostic test for CAD is planned.  About 10,000 participants from about 200-250 different hospitals and medical facilities will participate.  Augusta University and/or GRMC plan to enroll up to 50 subjects. Based on the specific type of resistance shown by your HIV virus, you may be included in one of two groups. For research purposes, participants may receive an exercise ECG, stress echo, stress nuclear or coronary computed tomography angiography (CTA).  The study also includes blood samples, questionnaires and telephone contact. The study will last approximately 42 months with a minimum 2-year follow-up period.
Subject Compensation:  The study sponsor is paying for procedures being done solely for the study. Subjects are responsible for all co-pays and standard of care treatment. Subjects will receive compensation for study participation.
Clinicaltrials.gov identifier: NCT01174550
Principal Investigator: Sheldon E. Litwin, MD
For More Information, Contact: Carol Smith, RN, at 706-721-0193 (csmith@augusta.edu

 

Study Short Name:  Spiral Acuity Registry
Indication:  Heart Failure
Purpose:  

This is an registry study designed to provide the sponsor with additional data about the performance of the implanted system. The device is already approved by the FDA, there is nothing investigational about the implanted system or procedure.

The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral LV Lead.

Subject Participation: Subjects are eligible for participation if they have been or will be implanted with the ACUITY Spiral Lead within 29 days, is, or will be implanted with a BSC commercially available LATITUDE-enabled PG and prescribed the LATITUDE Patient Management system, and plan to remain in the long-term care of his/her enrolling physician.  Subjects who consent will have the device checked approximately one month after the implant.  Routine, in-clinic follow-up schedule will be determined by the subject’s doctor and is suggested to be every six months.  The patient management system will conduct weekly monitoring as well as a complete device evaluation at least once every 3 months.
Subject Compensation:  The sponsor will pay for the special tests and examinations that are required by this study and not otherwise part of standard medical care. However, many of the tests, procedures, and exams are part of standard medical care, and may be covered by medical insurance.  Subjects will receive compensation for the first month’s visit to help cover transportation, meals, or other expenses related to participation in this study.
Clinicaltrials.gov identifier: NCT00955708
Principal Investigator: Adam E. Berman, MD
For More Information, Contact: Myrna Mattos, RN, at 706-721-9683 (mmattos@augusta.edu

 

Study Short Name:  Valcyte 
Indication:  Prevention of CMV disease
Purpose:   Researchers want to find out if valganciclovir called Valcyte® significantly affects the development of sperm, and its function, in adult men who receive a kidney transplant. If your physician thinks you are at risk of developing CMV after transplant, then he will prescribe up to 200 days of Valcyte® for you, whereas if he thinks you are at low risk, you will be followed as usual by your doctor. As renal failure and transplant both affect sperm quality and function, both patients who need Valcyte® after a transplant and those who do not, can be in the study. Another purpose of this study is to find out if Valcyte® is better than no treatment for infection.
Subject Participation: To be eligible to participate in this study, subjects must be scheduled to have a kidney transplant. The study does not change the regular care that your study doctor will provide to you.  It asks that at each study visit you donate semen for analysis and allow some additional blood samples to be collected.  These will be collected at your Study Visits on 6 separate occasions.  Approximately 40 subjects will be enrolled from research centers across the U.S. Augusta University and/or GRMC plan to enroll 4 subjects. Participation will last about 52 weeks. Study assessments include testicular toxicity, blood collection, safety, and current medications.
Subject Compensation:  Participants or their health insurance carrier will need to pay for Valcyte® during the study as part of their standard of medical care after kidney transplant.  Lab tests required as part of your participation in the study are paid for by the study. Participants will receive compensation for study participation.
Clinicaltrials.gov identifier: NCT01663740
Principal Investigator: Muralidharan Jagadeesan, MBBS
For More Information, Contact: Peggy Best, RN, at 706-721-9546 (pbest@augusta.edu

 

Study Short Name:  ZORO
Indication:  Influenza A Virus, H1N1 Subtype, Influenza B 
Purpose:   The purpose of this study is to test the safety of zanamivir and how well it works at different doses. Zanamivir will be compared with oseltamivir, which is used for treating flu. Subjects will get one of these two drugs: Zanamivir (also known as Relenza™) and oseltamivir (also known as Tamiflu™). Zanamivir is usually given to patients who have the flu, using an inhaler and oseltamivir is usually given to patients who have flu as a capsule to swallow or as a liquid. Oseltamivir is approved for doctors to prescribe to patients with flu; however, it has not been specifically tested in patients who have flu treated in the hospital. This study is testing a new intravenous form of zanamivir.
Subject Participation: Only hospitalized subjects with laboratory confirmed or suspected influenza infection are eligible to participate. About 462 people in about 30 countries will take part in this study. Augusta University and/or GRMC expect to enroll 3 subjects. Participants will receive Zanamivir 300 mg or 600 mg by IV twice daily or oral oseltamivir 75 mg twice daily for 5 days. For a given subject, the initial 5-day treatment course may be extended for up to 5 additional days if clinical symptoms or patient characteristics as assessed by the investigator warrant further treatment. Alternatively, if the investigator considers that a subject is failing to improve clinically on their randomized treatment, the investigator can choose to initiate the switch/rescue option (600 mg IV zanamivir twice daily) on any day from Day 6 through Day 10 for up to an additional 5 days of treatment. On switching treatments, subjects complete a maximum of 14 days of treatment and are followed-up to Post-Treatment +28 Days. Depending on when patients go home, they may need to come back to the hospital for one or two follow-up visits, and at the end of the study for final tests.
Subject Compensation:  The study sponsor is paying for procedures being done solely for the study. Subjects are responsible for all co-pays and standard of care treatment. Subjects will receive compensation for study participation.
Clinicaltrials.gov identifier: NCT01231620
Principal Investigator: James Wilde, MD
For More Information, Contact: Peggy Best, RN, at 706-721-9546 (pbest@augusta.edu