Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.

Date Added
May 6th, 2021
PRO Number
Pro00110062
Researcher
Gayenell Magwood

List of Studies


Keywords
Cardiovascular, Coronavirus, Diabetes, Hypertension/ High Blood Pressure, Minorities, Stroke
Summary

Underserved, racial and ethnic minority communities are experiencing higher rates of COVID-19 cases and associated mortality compared to whites due to long standing social and structural inequities that also drive disparities in chronic diseases such as stroke, cardiovascular disease, diabetes, and hypertension. Patients with underlying chronic diseases who are recovering from COVID-19 depend on the support of family and friends (informal caregivers/care partners) who are being exposed to the same pandemic and racial stressors, exposure that can affect the health and quality of life of both partners. The primary goal of this study is to test the efficacy of an adapted, telehealth-enhanced intervention that targets barriers impacting family illness management behaviors of Black/African American (AA) adult COVID-19 survivors and carepartner dyads for improved quality of life and COVID/chronic illness health related outcomes.

Institution
MUSC
Recruitment Contact
Gayenell Magwood
8437920685
magwoodg@musc.edu

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure with Preserved Ejection Fraction: Randomized Controlled Feasibility Trial- The REBALANCE-HF Study

Date Added
February 9th, 2021
PRO Number
Pro00107509
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular
Summary

This study will include volunteers diagnosed with a form of heart failure that is characterized by a weakened heart muscle that appears to be pumping in a normal manner. This condition is called "heart failure with preserved ejection fraction" or HFpEF. For these individuals, it has been determined that the health problems and symptoms experienced may be due to a significant increase in the pressure of one of the chambers of the heart. This pressure build-up causes a variety of symptoms, including tiredness, difficulty breathing, and reduced ability to exercise/walk.

This study is to help evaluate a new device (the "Axon System") designed to reduce the build-up of pressure described above. The Axon system is a catheter used to ablate or destroy the splanchnic nerve on one side of the body. The Sponsor believes by destroying this nerve there may be some reduction in the symptoms caused by HFpEF. The procedure using the Axon System will be performed in the catheterization lab and does not involve surgery. Participants will stay overnight in the hospital following the procedure for observation.

The length of subject participation in the study will be approximately 12 -14 months and includes 7 office visits, 2 phone calls and 3 procedures. Participants in this research study will be randomized to either the treatment group or the control group and have a 50:50 chance of receiving the research treatment with the Axon System at the time of randomization.

This study will help us learn more about how safe and effective the Axon System is in treating the symptoms of patients with HFpEF.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

VIVO Protocol: Feasibility of Merging VIVO with inHEART

Date Added
December 23rd, 2020
PRO Number
Pro00094238
Researcher
Michael Gold

List of Studies


Keywords
Cardiovascular
Summary

The purpose of the study is to give more information about how the VIVO software and inHEART software merge together and what potential benefits this could provide the physician for planning ablation procedures. In addition, the study will also provide information about the accuracy of VIVO in varying degrees of damaged hearts.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2244
adamsde@musc.edu

Training in Exercise Activities and Motion for Growth (TEAM 4 Growth): A Randomized Clinical Trial

Date Added
December 7th, 2020
PRO Number
Pro00084526
Researcher
Frances Woodard

List of Studies


Keywords
Cardiovascular, Children's Health, Heart
Summary

This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.

Institution
MUSC
Recruitment Contact
Mary Freeman
8437925762
freemanme@musc.edu

Safety and Effectiveness of TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE) for the Treatment of Drug Refractory, Symptomatic, Paroxysmal Atrial Fibrillation (TactiFlex PAF IDE Trial)

Date Added
October 13th, 2020
PRO Number
Pro00101068
Researcher
Michael Field

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this research study is to demonstrate that the TactiCath SE catheter is safe and effective for ablating (burning heart tissue using heat energy) your symptomatic, paroxysmal (starts and stops on its own) atrial fibrillation (irregular heart beat in upper chambers of heart) that is not effectively treated with medication. Participation in the study will last about 12 months from the time of the ablation procedure. Participants will be asked to complete follow-up visits at 7-days (phone call visit), 5 weeks (phone call visit) 3-months (in person visit), 6-months (in person visit), and 12-months (in-person visit). Data collected for this study will be submitted for review and approval by the U.S. Food and Drug Administration (FDA).

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu

Multicenter Study Into Individualized Scanning for Coronary Artery Disease (MINDS-CAD)

Date Added
July 14th, 2020
PRO Number
Pro00100282
Researcher
Uwe O.P. Schoepf

List of Studies


Keywords
Cardiovascular, Coronary Artery Disease
Summary

This study uses CT scans to visualize the heart and surrounding arteries to look for coronary artery disease. This study takes into account individuals body type including size, weight, and heart rate to tailor the CT scan and contrast media given to each patient. Taking into account each patients body will allow doctors to obtain the best image possible while reducing the amount of contrast media given to patients.

Institution
MUSC
Recruitment Contact
Hunter Gray
8438764922
grayhu@musc.edu

OPEN-LABEL EXPLORATORY STUDY OF ORAL MYK-491 IN STABLE AMBULATORY PATIENTS WITH PRIMARY DILATED CARDIOMYOPATHY DUE TO EITHER MYH7 OR TTN VARIANTS

Date Added
April 14th, 2020
PRO Number
Pro00095947
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Genetics
Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (the levels of drug in the blood) and pharmacodynamics (the effect of the drug on your body) of the study drug, MYK-491, when administered orally twice a day for about one to two weeks.The study will recruit patients with an enlarged heart and weakened heart muscle not caused by heart damage from a heart attack or heart valve problem. Eligible patients must also have a specific genetic mutation called MHY7. All subjects that qualify will receive MYK-491 (no placebo, or inactive pill will be dispensed during the study). The study medication is designed to improve cardiac contractility or the ability of the heart to squeeze.

This study has two treatment periods during which multiple doses of MYK-491 (the study drug) will be administered. Once Treatment Period 1 is completed, participants will return to the clinical site for study assessments and to obtain a dose for Treatment Period 2. The investigator will review the results of the study assessments and participants will learn if they will receive a lower or higher dose of MYK-491 for Treatment Period 2 than they received in Treatment Period 1. The expected study duration ranges from about 4 weeks to 11 weeks, including about 1-8 weeks for screening, 9 to 15 days for IMP dosing and an approximately 1 week (7±1 days) follow-up visit.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms

Date Added
March 24th, 2020
PRO Number
Pro00096973
Researcher
Richard Bayer

List of Studies


Keywords
Cardiovascular, Heart
Summary

The Revivent TC System study is being conducted to test an investigational device that can repair a Left Ventricular Aneurysm without the use of a heart-lung machine, or opening the chest/heart chamber. The device works by placing a tuck in the heart where there is scar, which has the effect of shortening the distance across the heart and decreasing the tension, or stress, on the working heart muscle. The device consists of several implants, called anchors. The anchors are placed during a surgery in which your doctors will access your heart by placing a guide wire through a vein in your neck into your heart and also through an incision in your chest wall between your ribs on your left side. The anchors will help reshape your heart muscle by tucking in the scarred area. It is expected that the total study duration will be approximately 6 years, consisting of 1 year of patient enrollment and 5 years of patient follow-up.

Institution
MUSC
Recruitment Contact
Deborah Everidge
8437922244
adamsde@musc.edu

PIVOTAL EVALUATION OF THE ACCESS NATRIURETIC PEPTIDE ASSAY(S) AS AN AID IN THE DIAGNOSIS AND ASSESSMENT OF SEVERITY OF ACUTE HEART FAILURE – EMERGENCY DEPARTMENT SUBJECT ENROLLMENT AND SPECIMEN COLLECTION

Date Added
February 17th, 2020
PRO Number
Pro00095805
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular, Heart
Summary

This is a prospective, multicenter clinical trial for individuals presenting to the Emergency Department with suspicion of acute heart failure. A blood sample collected will be used to compare the standard of care BNP test used at the local site to the investigational assay from Beckman Coulter (sponsor).

The diagnosis and treatment of patients at each site will use an FDA-cleared BNP or NT-proBNP assay under the site's standard of care and NOT the investigational assay.

Institution
MUSC
Recruitment Contact
Annelise Kauffman
843-792-3576
kauffmaa@musc.edu

RELIEVE-HF TRIAL: REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure

Date Added
January 14th, 2020
PRO Number
Pro00095660
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Heart, Hypertension/ High Blood Pressure
Summary

The purpose of the study is to evaluate the safety and how well the V-Wave Interatrial Shunt works. The study will also look at information obtained from the tests performed to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 1 year to up to 7 years depending on randomization group. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks. There will be a minimum of 10 or up to 15 planned research clinic visits. Subjects will have 1 overnight hospital stay for the study related RHC and research procedure. Due to the COVID-19 pandemic, study participants may be discharged the same day when necessary. Each participant will receive a phone call between all study visits.

Subjects will have a 50:50 chance of receiving the Shunt during the randomization procedure (like the flip of a coin). Neither the subject, nor the blinded study doctor or blinded study coordinator will know which group subjects are in. Participants will be randomized to either the treatment group (and receive the Shunt) or the control group (and not receive the shunt). Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu



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