Human Samples Bio Repository Save

Date Added
August 21st, 2018
PRO Number
Pro00072807
Researcher
Federica Del monte

Silhouette
Keywords
Aging, Cardiovascular, Coronary Artery Disease, Genetics, Heart, Military, Sarcoidosis, Scleroderma, Transplant, Vascular
Summary

The purpose of the study is to generate a bio bank of specimens for research. We will tissue that would otherwise be discarded from clinical or surgical procedure and information from medical records. We will also collect discarded blood, urines and sputum. Collecting samples will help to better understanding the mechanisms of cardiovascular diseases, identify biomarkers for early diagnosis and to predict safety and efficacy of new therapies.

Institution
MUSC
Recruitment Contact
Federica del Monte
843-792-8397
delmonte@musc.edu

Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System (EVAS II Confirmatory Study) Save

Date Added
May 29th, 2018
PRO Number
Pro00076073
Researcher
Firas Mussa
Keywords
Vascular
Summary

This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess safety and effectiveness outcomes. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Institution
Palmetto
Recruitment Contact
Firas Mussa, MD
803-545-5800
Evelyn.Kennedy@PalmettoHealth.org

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care Study of n-Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke in Adult Subjects Save

Date Added
February 22nd, 2018
PRO Number
Pro00073072
Researcher
Souvik Sen
Keywords
Brain, Nervous System, Stroke, Vascular
Summary

This study will assess patients with acute ischemic strokes being treated with n-Butylphthalide (NBP) softgel capsules. This is a phase II study to evaluate the safety of NBP treatment. The medication has the potential to reduce impairment of memory function, cerebral edema, and disruption of the blood-brain barrier.

Institution
Palmetto
Recruitment Contact
Viktoriya Duda
(803)545-6071
viktoriya.duda@uscmed.sc.edu

Research Trial for Optimized Nonenhanced 3T QISS MR Angiography of the Peripheral Arteries Save

Date Added
August 17th, 2017
PRO Number
Pro00070277
Researcher
Uwe o.p. Schoepf

Silhouette
Keywords
Cardiovascular, Vascular
Summary

The purpose of this study is to evaluate the use of a non-contrast MRI for the assessment of the vasculature of the lower extremity anatomical regions. Patients eligible for this study must have been referred for a clinical contrast enhanced CT scan or an invasive catheter angiography. The overall image quality and diagnostic accuracy of the non-contrast MRI will be compared to current clinical standards of care, such as contrast enhanced MRI, CT, and invasive angiography.

Institution
MUSC
Recruitment Contact
Brian Jacobs
843-876-4922
Jacobsbr@musc.edu

Brain Circuitry Changes in Vascular Parkinsonism Save

Date Added
July 6th, 2017
PRO Number
Pro00063429
Researcher
Christine Cooper

Silhouette
Keywords
Parkinsons, Vascular
Summary

This study will examine changes in brain architecture that are associated with vascular parkinsonism, in comparison to Parkinson's disease. We will do this by using advanced imaging techniques to compare brain structure between subjects with vascular parkinsonism and Parkinson's disease.

Institution
MUSC
Recruitment Contact
Nancy Feracco
843-792-7859
feracco@musc.edu

A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay Pro Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers Save

Date Added
April 21st, 2017
PRO Number
Pro00063368
Researcher
Daniel Clair
Keywords
Cardiovascular, Surgery, Vascular
Summary

This study is intended to include patients with a Thoracic Aortic Aneurysms (TAA) or Penetrating Atherosclerotic Ulcers (PAU) and assess and evaluate safety and performance data of the RelayPro Stent-Graft System. A TAA is a weakening and bulging of the thoracic aorta, which is the body's main blood vessel that carries blood away from your heart to all parts of your body. A disease called atherosclerosis, in which fatty material accumulates under the inner lining of the arterial wall, generally causes true aneurysms. PAUs are lesions associated with aortic wall thickening and appear similar to saccular aneurysms (sac-like bulging) on x-ray. If left untreated, an aneurysm or ulcer can enlarge and rupture, causing injury or death.

Institution
Palmetto
Recruitment Contact
Daniel Clair
(803)-545-5800
Daniel.Clair@uscmed.sc.edu

Actelion Protocol AC-055-205: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients with Pulmonary Hypertension After Left Ventricular Assist Device Implantation Save

Date Added
August 5th, 2016
PRO Number
Pro00053983
Researcher
Patrick Mccann
Keywords
Cardiovascular, Drug Studies, Heart, Pulmonary Arterial Hypertension (PAH), Vascular
Summary

The Actelion SOPRANO study is a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase II study to evaluate the safety and effect of macitentan on pulmonary vascular resistance in subjects with pulmonary hypertension after left ventricular assist device (LVAD) implantation. Male and female patients 18 years of age or older who have had surgical implantation of LVAD may be eligible to participate in this study.

Study Site:
Palmetto Heart
8 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Patrick McCann, MD at 803-434-3800

Institution
Palmetto
Recruitment Contact
Patrick McCann
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

ASSESSMENT OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS IN THE TREATMENT OF ABDOMINAL AORTIC ANEURYSMS Save

Date Added
October 27th, 2015
PRO Number
Pro00047297
Researcher
Ravi Veeraswamy

Silhouette
Keywords
Surgery, Vascular
Summary

This study is being conduct to assess the safety and effectiveness of a Study Sevice,GORE® EXCLUDER® Conformable AAA Endoprosthesis, in patient's with an aneurysm in their abdominal aorta. In this research study, the Study Device will be placed inside the abdominal aorta (in the approximate area of the belly button) and the Study Device will extend into both leg arteries. The Study Device will block the aneurysm (the weakened and bulging part of the artery) in the abdominal aorta from blood flow while maintaining blood flow to the arteries in the legs. Information will be collected on the performance of the Study Device for up to five (5) years.

Institution
MUSC
Recruitment Contact
Corie Lynn
843-792-8874
lynnc@musc.edu

PeRiodontal treatment to Eliminate Minority InEquality and Rural disparities in Stroke Save

Date Added
July 21st, 2015
PRO Number
Pro00044329
Researcher
Souvik Sen
Keywords
Periodontal Disease, Stroke, Vascular
Summary

The PREMIERS study is a proposal for conducting an adequately powered two center phase III randomized controlled trial to test whether intensive periodontal treatment reduces the risk of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the resources in both states including established
dental centers, Joint Commission Certified Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to Eliminate Health Disparities. The proposal addresses specific issues with regards to recruitment of African-American and rural stroke/TIA patients advocating the use of culturally appropriate strategies to educate the study subjects regarding stroke, periodontal disease and the periodontal stroke link.
The study proposes to utilize economic evaluation of the periodontal intervention from the budgetary
perspective. The focus will be on the financial sustainability of providing aggressive periodontal therapy (with
certain, although relatively low expenditures) in exchange for a reduction of uncertain recurrent vascular events
that may require high cost emergency department utilization and/or inpatient care. The sustainability of the
proposed intervention after the completion of the project is integrally linked to the health economic assessment
to show the health care cost savings. By integration with a rural primary care center, with an African American
majority and households with average incomes below the state average, the study ensures that the proposed
intervention to reduce stroke disparity is applicable to this target population.

Institution
Palmetto
Recruitment Contact
Lauren Giamberardino
8035456078
lauren.dennis@uscmed.sc.du

Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence Save

Date Added
June 2nd, 2015
PRO Number
Pro00043450
Researcher
Teresa Kelechi

Silhouette
Keywords
Aging, Circulation, Diabetes, Inflammation, Skin, Vascular
Summary

Individuals with venous leg and diabetic foot ulcers often find these ulcers take a long time to heal and when they do, sometimes they come back. These ulcers can be quite painful making it hard to work, sleep and go about one's day to day activities. You will be asked to do a self-care routine of taking the temperature of the skin where the leg or foot ulcer just healed with a special thermometer and applying a small cooling gel patch over this skin. We want to know if this routine will prevent the ulcer from coming back, help you to become more active, and improve the quality of your life.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843 792 4771
prenticm@musc.edu

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