Targeting Biomechanical Signaling in AAA

Date Added
January 17th, 2024
PRO Number
Pro00132068
Researcher
Jean Ruddy

List of Studies


Keywords
Vascular
Summary

Patients with large abdominal aortic aneurysms (AAA) (>5.5cm) are recommended to have surgery, but there is no therapy for small AAA (3-5cm). The purpose of this study is to collect ultrasound images and blood from patients with normal abdominal aorta as well as from patients with small AAA. Study participants include patients scheduled for an aortc ultrasound aorta and may fall into one of these categories. By analyzing the aortic wall ultrasound images and the blood levels of particular proteins, we hope to identify a target for drug therapy to stop AAA growth. Voluntary participation in this study does not change the original intent of the ultrasound and does not change patient treatment. The pictures gathered here are in addition to the standard ultrasound and cause no additional risk. Participation would include the standard aorta ultrasound, specific extra pictures (less than 5 minutes to collect), and collection of a blood sample. If a participant's aorta is within normal limits, no additional ultrasound visits or study visits will be indicated. If the participant has a small AAA, standard of care would be to return once per year for repeat ultrasound. Ongoing participation in the study will be to have the extra ultrasound images captured and repeat blood sampling, for a total of 3 years.

Institution
MUSC
Recruitment Contact
Jean Ruddy
843-876-8568
ruddy@musc.edu

A Multi-Site Observational Clinical Investigation to Collect Non-invasive Sensor Data During a Right Heart Catheterization and Train Machine Learning Models to Estimate Intracardiac Hemodynamic Parameters

Date Added
January 17th, 2024
PRO Number
Pro00134601
Researcher
Anthony Carnicelli

List of Studies

Keywords
Cardiovascular, Heart
Summary

The study uses a monitoring system to measure pressures inside the heart and lungs in a non-invasive way. This monitoring system consists of a handheld electronic device, similar to a smartphone, which will be placed on the chest and a smartwatch to wear on the wrist. Ultimately, the monitoring system will be intended to be used by doctors as a tool to support them when assessing patients with symptoms that may be due to a condition of their heart and/or lungs.

The purpose of this study is to collect data from eight sensors built in the study device (the smartphone and the watch). The data collected from the device, as well as the data collected during your Right Heart Catheterization, will be uploaded in a database. Once all subjects have been enrolled in the study, these data are then used to build the software which will be used in the final monitoring system. The device used in this study is not approved for commercial use and can only be used in clinical investigations.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

A PHase 1/2 Study of the Safety and Efficacy of LX2020 Gene TheRapy in Patients with ArrhythmOgenIc Cardiomyopathy (ACM) due to a PlaKoPhilin-2 (PKP2) Pathogenic Variant

Date Added
January 23rd, 2024
PRO Number
Pro00133595
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is seeking participants with arrhythmogenic cardiomyopathy (ACM), also known as arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C), due to a genetic abnormality known as a PKP2 variant. ARVD/C is an inherited disease where the muscle tissue in the right ventricle, one of the lower pumping chambers of the heart, dies and is replaced with scar tissue. This causes a weakened heart muscle and disrupts the heart's electrical system which can lead to heart failure and/or fatal heart rhythms. This study is looking at the safety and effectiveness of an investigational medication, meaning it is not yet approved for use by the Food and Drug Administration (FDA). The study medication is a gene therapy called LX-2020, and is designed to add new PKP2 genes to replace the faulty ones so your cells can make the correct PKP2 genes. The study medication is given via an intravenous (IV) line meaning in a vein. Participation in this study involve up to 25 visits including a hospitalization over the course of 1 year with an additional 4 years of follow up afterwards. Study related procedures include a variety of heart testing like electrocardiogram (ECG), echocardiogram, a test that records a tracing of the heart's electrical activity, Echocardiogram, (echo) a test that uses ultrasound to capture moving images of the heart, magnetic resonance imaging (MRI), a test that shows an image of the heart and surrounding structures, sample collection including blood, urine, tissue, nasal mucus, saliva and stool, liver ultrasound, questionnaires, physical exams, and at least a two night stay in the hospital. Medications to suppress (meaning weaken) the immune system, before receiving the LX2020 are also required. Risks associated with gene therapy include an immune response that may cause inflammation in the liver, heart or other organs. It may damage red blood cells, cause a low platelet count or cause the formation of small blood clots. There are also risk related to the study procedures including bleeding associated with the heart biopsy, risks related to drawing blood, risks of radiation, and loss of confidentiality. There is potential benefit and in the future, others with ACM may benefit from the knowledge gained from this study.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Arm Study to Assess the Safety and Efficacy of a Single Treatment of BOTOX®, Followed by an Optional Open-Label Treatment with BOTOX®, in Female Subjects with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Date Added
January 29th, 2024
PRO Number
Pro00120543
Researcher
Eric Rovner

List of Studies


Keywords
Bladder
Summary

The purpose of this study is to investigate the safety (what side effects the study treatment may have) and effectiveness (how well the study treatment works to relieve symptoms) of BOTOX when injected into the bladder of adult females for the treatment of Interstitial Cystitis/ Bladder Pain Syndrome. Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological condition characterized by symptoms of bladder pain or discomfort and accompanied by lower urinary tract symptoms such as frequent toilet visits, often also during bedtime. BOTOX might be able to temporarily reduce bladder pain/discomfort and improve your accompanying urinary symptoms. There will be a total of 9 study visits over a period of approximately 28 weeks which includes up to 28 days (4 weeks of screening), a treatment visit, and 24 weeks of follow-up if you receive only one treatment. If you choose to receive a second treatment (which will be BOTOX), you could have a total of up to 13 visits and be in the study for an additional 12 weeks for a total of up to 44 weeks (depending on when you request retreatment) which includes the 28 days (4 weeks of screening). If you are already
receiving treatment for IC-BPS, after you have signed the informed consent, you may have to washout of your medication prior to screening and throughout your study participation. If you have a urinary tract infection [UTI] that requires treatment, an additional 14-day extension is allowed to receive Treatment 2 for total study
participation of up to 46 weeks. You may need to attend additional unscheduled visits for safety or other reasons.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
8438760630
jenkijn@musc.edu

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu

Determinants of performance in cochlear implant listeners

Date Added
February 6th, 2024
PRO Number
Pro00133091
Researcher
Kelly Harris

List of Studies


Keywords
Hearing
Summary

This project examines how to improve speech understanding with cochlear implants (CIs), particularly for older CI recipients. While older individuals benefit from CI technology, performance is poorer than that of younger implanted adults for difficult listening tasks. The mechanisms that contribute to this variability are not well-understood. The current project examines how differences in brain structure and function may contribute to success with a cochlear implant. To compare, we will also be examining how older patients without cochlear implants understand speech in difficult listening situations.

Institution
MUSC
Recruitment Contact
Kelly Harris
8437922061
harriskc@musc.edu

A Phase 3 Randomized Study Comparing Talquetamab in Combination With Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Date Added
February 6th, 2024
PRO Number
Pro00133322
Researcher
Kimberly Green

List of Studies

Keywords
Cancer, Men's Health, Women's Health
Summary

The study is for a patient that have been diagnosed with multiple myeloma. The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first).

Institution
MUSC
Recruitment Contact
Shanta Salzer
8437929300
salzers@musc.edu

Phase III Randomized Trial of Immunotherapy with or without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma

Date Added
February 12th, 2024
PRO Number
Pro00132402
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck
Summary

In this study, the participants will take pembrolizumab for 24 months or get pembrolizumab plus a course of radiation therapy for 24 months until the cancer progresses. After the study treatment is finished, the study doctor will continue to follow the participants condition for a total of 3 years. Some risks in this study is that pembrolizumab with radiation may not be as good as the usual approach for cancer shirking or stabilizing. Some risks associated with pembrolizumab and radiation which are reduction in blood counts, mouth or throat pain and difficulty swallowing. The potential benefit of this study is that radiation and chemotherapy/pembrolizumab can be effective at shrinking or stabilizing the cancer. The purpose of this study is to compare using pembrolizumab with radiation to pembrolizumab without radiation.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Date Added
February 13th, 2024
PRO Number
Pro00134508
Researcher
Jessica Atkins

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is enrolling subjects with non-obstructive hypertrophic cardiomyopathy (nHCM). nHCM is typically a genetic condition in which the main pumping chamber of the heart (called the left ventricle) becomes abnormally thickened and stiff, which makes it harder for the ventricle to fill and pump out enough blood. This study involves the investigational medication Aficamten, which means it is not approved for commercial use by the Food and Drug Administration. (FDA) Aficamten is designed to reduced excessive heart pumping function. This is a randomized study which means all subjects are assigned to receive either Aficamten or placebo. Subjects have a 50:50 chance of being assigned to either group, but will not know which group they are assigned. Placebo looks like the medication but does not have any active ingredients in it. Study procedures include exercise testing, echocardiograms (ultrasound test of the heart), blood work, questionnaires and genetic testing. Study risks include risks associated with the study medication including decreased heart pumping, nausea, headache and dizziness. There are also study procedure related risks, and the risk of loss of confidentiality. There may be no benefit but the information learned may benefit others in the future. Study participation will last between 10.5 and 19 months and include up to 13 visits to the study site. Visits will generally last 2-3 hours.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu



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