Right Ventricular Reserve Measures with Cardiac MRI Save

Date Added
October 16th, 2019
PRO Number
Pro00085562
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Cardiovascular, Heart, Sarcoidosis, Scleroderma, Shortness of Breath
Summary

This research study aims to determine a less invasive way to assess heart function by taking measurements of the heart while subjects are performing an exercise cardiac MRI. Subjects will undergo two exercise phases and MRI measurements will be taken after each exercise phase. These measurements will be compared to available clinical data (including demographic, hemodynamic, radiologic, and functional) and future outcome data.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension Save

Date Added
September 24th, 2019
PRO Number
Pro00091232
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

This is a study for patients with high blood pressure. The purpose of this study is to evaluate the safety and effectiveness of renal denervation while you are still on your blood pressure medications. Renal denervation is a procedure that destroys the nerve fibers that run along the kidney blood vessels interrupting nerve signals that may cause high blood pressure.The purpose of the treatment (renal denervation) is to lower blood pressure. You will undergo renal angiography (RA), which you may or may not receive the study treatment (depending upon your study assignment). The sponsor has manufactured a new drug/device combination product called the Peregrine System™ Kit (also referred to as the Peregrine Kit). The Peregrine Kit contains a device, the Peregrine System™ Infusion Catheter (also referred to as the Peregrine Catheter), and a drug dehydrated alcohol for injection (also referred to as alcohol). Therefore, the effectiveness of the study catheter and the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces your blood pressure. The participant will be asked to return to the doctor's office for follow-up visits at 4 and 8 weeks, 3, 4, 5 and 6 months, and 1, 2, and 3 years after the procedure. At the 1 year visit, the participant will find out if he/she got the treatment, and if he/she did not, they can choose to cross-over to the treatment if they still meet eligibility criteria.

Institution
MUSC
Recruitment Contact
Anthony Awkar
8438765009
awkar@musc.edu

Repository of Phase Signals for Pulmonary Hypertension Algorithm Development Save

Date Added
September 10th, 2019
PRO Number
Pro00089125
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

The purpose of this study is to build a repository (collection) of heart signals from eligible subjects. The experimental part of this study is the collection of heart signals using a device similar to a heart monitor called the Phase Signal Acquisition System. The signals will be electronically sent to a storage center and paired with the subject's heart catheterization results for future use in research and development activities sponsored by Analytics 4 Life. The study will include up to 1500 participants at up to 20 research sites in the United States and will require approximately one hour of the subject's time. There are no follow-up visits. .

Institution
MUSC
Recruitment Contact
Anthony Awkar
7928526
awkar@musc.edu

Building a Repository of Cardiac Phase Signals for Algorithm Development Recruiting Mostly Female Subjects Save

Date Added
September 10th, 2019
PRO Number
Pro00088809
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

The purpose of this study is to build a repository of heart signals from eligible subjects. The experimental part of this study is the collection of the participant's heart signals using a device similar to a heart monitor called the Phase Signal Acquisition System. The signals will be electronically sent to a storage center, then compared to the results of the participant's heart catheterization and saved for future research and development activities sponsored by Analytics 4 Life. The study will include up to 2500 participants at up to 20 research sites in the United States and will require approximately one hour of the subject's time. There are no follow-up visits.

Institution
MUSC
Recruitment Contact
Anthony Awkar
7928526
awkar@musc.edu

The Effect of Congenital Heart Disease on Employment, Neuropsychological Outcomes, and Quality of Life in Adults with Down Syndrome Save

Date Added
August 13th, 2019
PRO Number
Pro00090744
Researcher
Stephanie Gaydos

List of Studies

Keywords
Cardiovascular, Memory Loss
Summary

The proposed study will investigate the effect of congenital heart disease (CHD) on rates of employment, community participation, neuro-psychological comorbidities, and quality of life (QOL) in adults with Down syndrome. Knowledge of these longitudinal functional outcomes may assist clinician guidance to families and highlight needs for specific resources and interventions to achieve optimal outcomes in adulthood.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
2-1213
choudhar@musc.edu

Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy Save

Date Added
July 17th, 2019
PRO Number
Pro00088171
Researcher
Allison Eckard

List of Studies

Silhouette
Keywords
Body Composition, Cardiovascular, Drug Studies, Healthy Volunteer Studies, HIV / AIDS, Immune System, Infectious Diseases, Inflammation, Insulin, Liver, Metabolism, Minorities, Obesity, Weight Control
Summary

This is a randomized, double-blinded, placebo-controlled phase 2b clinical trial to characterize, examine and compare the effects of GLP-1 receptor agonist (semaglutide) in HIV-infected adult individuals with lipohypertrophy versus healthy controls with obesity but without HIV.

The two populations will be studied in separate but similarly-designed studies running in parallel.

Subjects in both populations will be assigned by chance (1:1) to semaglutide or placebo.

Institution
MUSC
Recruitment Contact
Lisa Martin
(843) 876-5699
martinl@musc.edu

Management of Patients Presenting with Acute Chest Pain Following Coronary Computed Tomography Angiography Save

Date Added
July 9th, 2019
PRO Number
Pro00087460
Researcher
Uwe o.p. Schoepf

List of Studies


Profiles_link
Keywords
Cardiovascular, Coronary Artery Disease
Summary

Patients who present to MUSC's Chest Pain Center with acute chest pain and have undergone coronary computerized tomography angiography or triple rule-out computed tomography imaging showing an intermediate stenosis will be prospectively selected. Consented patients will then have their clinical indicated coronary computerized tomography angiography or triple rule-out computed tomography imaging undergo an expedited computed tomography-fractional flow reserve analysis analysis. This analysis will be provided to Chest Pain Center physician of record to aid in downstream patient treatment decision making. Patients will then be followed-up at 3-months via telephone call and electronic medical records review.

Institution
MUSC
Recruitment Contact
Dante Giovagnoli
8438764922
giovagnd@musc.edu

SURVEILLANCE HEARTCARE® OUTCOMES REGISTRY (SHORE) Save

Date Added
June 19th, 2019
PRO Number
Pro00086580
Researcher
Adrian Van Bakel

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this registry is to observe outcomes of heart transplant recipients who are managed with HeartCare. This is done by collecting information about the participant's heart transplant such as test results, biopsy results, and outcomes, storing that information in a database, and using that information for research. HeartCare is a combination of two tests from one blood draw. One test, AlloMap®, is a well-established test for heart transplant recipients. The other test, AlloSure-Heart, is a new test that directly measures injury of the transplanted heart. HeartCare provides the results of both tests for a noninvasive assessment at time of testing. The registry will be active for up to 5 years after enrollment.

Institution
MUSC
Recruitment Contact
Anthony Awkar
8438765009
awkar@musc.edu

A Randomized Controlled Trial Comparing Monitored Anesthesia Care versus General Anesthesia with Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement Save

Date Added
June 18th, 2019
PRO Number
Pro00088473
Researcher
George Whitener

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart, Surgery
Summary

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Institution
MUSC
Recruitment Contact
Christine Aanstoos
8437921869
aanstoos@musc.edu

ECG Belt for CRT Response (ECG Belt) Save

Date Added
May 19th, 2019
PRO Number
Pro00085400
Researcher
Michael Field

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this study is to compare the management of CRT device patients using the Medtronic ECG Belt Research System and using routine hospital practice. The participant will be assigned (randomized) to one of 3 study groups. The ECG Belt Research System will be used for data collection at Post-Implant follow-up, 6 months, and 9 months for all groups, in addition to the following:

? Group 1 ? About 200 subjects will be in this group. If participant is in Group 1, he/she will have an ECG Belt guided implant procedure. The ECG Belt Research System will be used to help with the programming of device at Post-Implant follow-up and the 6 month visit.
? Group 2 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at your post-implant follow-up visit. It will be used to help with the programming of device at the 6 month visit.
? Group 3 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at the post-implant follow-up visit and 6-month visit.

The ECG Belt Research System is investigational because it is not approved to be used outside of a study. The experimental procedures in this study are: The ECG Belt guided implant procedure and optimizing CRT settings using the ECG Belt Research System.

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

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