A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ≥ 27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Date Added
June 25th, 2024
PRO Number
Pro00136763
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Kidney, Obesity, Stroke Recovery
Summary

Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

Combining rTMS & aerobic exercise to treat depression and improve post-stroke walking (RESTORATION)

Date Added
July 2nd, 2024
PRO Number
Pro00137804
Researcher
Chris Gregory

List of Studies


Keywords
Depression, Rehabilitation Studies, Stroke Recovery
Summary

We will determine if aerobic exercise (AEx) and/or repetitive transcranial magnetic stimulation (rTMS) are effective in treating symptoms of depression following stroke. This project is based on the idea that depression negatively affects the brain so that it doesn't change in the same way following treatment, the result being less effective recovery. We believe that effective treatment for depression will help improve how the brain in people with depression responds to other types of treatment. That is, effectively treating depression will enable individuals to better recover other forms of function following their stroke.

Institution
MUSC
Recruitment Contact
Alyssa Chesnutt
843-792-8171
hydar@musc.edu

Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

Date Added
August 29th, 2024
PRO Number
Pro00136755
Researcher
Sami Al Kasab

List of Studies


Keywords
Stroke
Summary

This study aims to establish the best clinical practice for the management of acute ischemic stroke related to narrowing or blockage of the neck vessels. Currently, the treating physicians use one of two surgical approaches based on their preference. However, we do not know which technique is the best. In this study, you will undergo mechanical thrombectomy using one of the techniques (stenting vs. non-stenting approaches) to determine which technique is better compared to the other.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843-792-8606
lemattyc@musc.edu

The Development of Patient-Centered Clinical AFO prescription Guidelines to Optimize Post-Stroke Function and Quality of Life

Date Added
September 25th, 2024
PRO Number
Pro00138736
Researcher
Steven Kautz

List of Studies


Keywords
Stroke Recovery
Summary

The goal of this study is to get the highest possible quality of life restuls for individuals suffering lower-limb impairment after suffering a stroke. This will be done by examining three different modern carbon fiber ankle-foot orthosis (AFO) options targeting the rehabilitation of individuals post-stroke. The study seeks to achieve the best AFO prescription that maximizes the mobility and satisfaction of the particpant.

Institution
MUSC
Recruitment Contact
Kelly Krajeck
843-792-9329
krajeck@musc.edu

Strategy for Improving Stroke Treatment Response

Date Added
September 26th, 2024
PRO Number
Pro00136289
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The research is being done to determine if an investigational drug called "TS23" is safe and effective for the treatment of patients with an ischemic stroke that do not meet the criteria for standard treatments to remove the clot. The best dose of TS23 for these patients is unknown. Prior studies have shown that TS23 works without increasing safety concerns.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843 792 8606
lemattyc@musc.edu

Modified cardiac rehabilitation to enhance post-stroke physical and psychosocial function: does depression limit the response?

Date Added
December 3rd, 2024
PRO Number
Pro00140518
Researcher
Ryan Ross

List of Studies

Keywords
Depression, Exercise, Stroke, Stroke Recovery
Summary

Cardiac rehabilitation is the standard-of-care treatment option for patients with cardiovascular disease and has been shown to improve many aspects critical to patient recovery. We believe that individuals who have had a stroke need to be treated similarly. We will study the effects of a comprehensive modified cardiac rehabilitation program to determine if it can improve some of the physical and psychosocial problems common in survivors of stroke with and without depression.

Institution
MUSC
Recruitment Contact
Ryan Ross
843-792-3477
rossre@musc.edu

Centering Emotional Recovery Post-Stroke

Date Added
January 7th, 2025
PRO Number
Pro00138136
Researcher
Michelle Woodbury

List of Studies


Keywords
Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Stroke survivors routinely report disabling emotional health challenges and inability to find emotional wellness support. This project will increase emotional support within a stroke rehabilitation occupational therapy (OT) and/or speech therapy (ST) rehabilitation program. OT and/or ST provided via telerehabilitation will be enhanced with a type of emotional wellness therapy that teaches stroke survivors various strategies to better address anxiety, worry and dread.

Institution
MUSC
Recruitment Contact
Kelly Rishe
843-985-1773
callahk@musc.edu

StrokeNet Thrombectomy Endovascular Platform

Date Added
February 6th, 2025
PRO Number
Pro00140267
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large or medium vessel occlusions (LVOs and MVOs).STEP is a registry-based trial; it uses data from existing registries to record information for a subset of the trial Case Report Form (CRF). Additional registry data from non-randomized STEP patients may be used for trial screening, planning, and generalizability assessment purposes.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843-792-8606
lemattyc@Musc.edu

Telehealth-Enhanced Assessment and Management after Stroke-Blood Pressure (TEAMS-BP)

Date Added
March 12th, 2025
PRO Number
Pro00142851
Researcher
Christine Holmstedt

List of Studies


Keywords
Hypertension/ High Blood Pressure, Stroke, Stroke Recovery
Summary

The purpose of this study is to determine the best strategy to help individuals improve blood pressure control after a stroke. The study will test two different interventions (an intervention is an action taken to prevent or treat disease and/or improve health).

1) Intensive Clinic Management (ICM), which consists of clinic visits, home blood pressure monitoring, text message health reminder from Carium®, a care management application, and health education.
2) Intensive Tailored Telehealth Management (ITTM), which consists of telehealth (video) visits, health coaching with lifestyle coaching company INTERVENT International, LLC, and remote blood pressure monitoring captured in Carium®.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
(843) 792-8606
lemattyc@musc.edu

Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation

Date Added
March 13th, 2025
PRO Number
Pro00142437
Researcher
Rachel Kaplan

List of Studies

Keywords
Cardiovascular, Heart
Summary

Atrial fibrillation (AF) is an arrhythmia in which the heartbeat becomes irregular due to abnormal electrical signals in the upper chambers of the heart, called the atria. This leads to ineffective pumping of blood by the atria. Complications related to atrial fibrillation are heart failure, stroke, heart palpitations and fatigue. This study is motivated by the need to address the increasing prevalence of AF, which is the most common sustained arrhythmia worldwide. While treatment options for AF include the use of antiarrhythmic drugs which are a group of medications used to treat irregular heartbeats, and catheter ablation procedures, the latter have been associated with significantly better outcomes. Participation in this study consists of 2 phases, 1- randomization 2- ablation procedure and follow-up period.
The randomization to the different groups is considered the research part of the study. Subjects will have equal chance of being randomized (like tossing a coin) to one of two AF ablation treatment groups. All follow up will be according to stand of care practices. Risks include stroke, pericarditis, acute and delayed perforation, hemolysis, acute kidney injury, and coronary artery spasm.

Institution
MUSC
Recruitment Contact
Krista Szymanski
843-876-5783
szymankr@musc.edu



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