A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation Save

Date Added
April 10th, 2018
PRO Number
Pro00075889
Researcher
Daniel Judge

List of Studies

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Keywords
Cardiovascular, Drug Studies, Genetics
Summary

The purpose of this research study is to test if ARRY-371797 is safe and effective in treating dilated cardiomyopathy caused by a genetic mutation to the LMNA gene. This will be demonstrated by the functional capacity of patients in their 6-minute walk tests and quality of life questionnaires.

Institution
MUSC
Recruitment Contact
Anita Smalls
843-876-5011
smaani@musc.edu

Dilated Cardiomyopathy (DCM) Research Project Save

Date Added
March 14th, 2018
PRO Number
Pro00076301
Researcher
Daniel Judge

List of Studies

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Keywords
Cardiovascular
Summary

The purpose of this study is to identify gene changes that cause DCM and gene differences that influence the development and severity of DCM. These genetic studies may identify a change in a gene that has already been linked with DCM, a change in a gene not previously associated with DCM, or these studies may identify a gene or genes that affect the development and severity of the DCM. With this knowledge we hope to have a better understanding of how genes and gene changes cause DCM.

Institution
MUSC
Recruitment Contact
Anna Tecklenburg
8437925863
tecklenb@musc.edu

The Association between Arterial Stiffness and Cognitive Impairment Risk in non-stroke controls (TAASCIR) Save

Date Added
February 26th, 2018
PRO Number
Pro00074521
Researcher
Joy Jones buie

List of Studies

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Keywords
Brain, Cardiovascular, Hypertension/ High Blood Pressure, Minorities, Stroke, Stroke Recovery
Summary

The purpose of this research study is to understand the association between heart and brain health in a population of 40-75 year olds. In this study, we will work to better understand blood vessel stiffness and brain function in African American and non-Hispanic white individuals. You will be asked to give blood during the study visit. Additional information will be obtained to help the researcher better understand the blood vessel and brain function data collected. There is only one study visit that last roughly 2 hours and compensation will be available.

Institution
MUSC
Recruitment Contact
Joy Jones Buie
8437926098
jonejn@musc.edu

Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-responders and Previously Untreatable Patients Save

Date Added
February 13th, 2018
PRO Number
Pro00074653
Researcher
John Sturdivant

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart
Summary

The purpose of the study is to test a new way to pace the left side of the heart without using pacing leads, using the WiSE CRT System. In this study, ultrasound will be used to transfer energy from a new type of pacemaker through your body to a special receiver that is placed inside the left ventricle of your heart. The receiver will use the ultrasound energy to pace the heart without using pacing leads.

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

The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis ? Above and Below the Knee Save

Date Added
February 13th, 2018
PRO Number
Pro00073943
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

Peripheral vascular interventions are minimally invasive options for the treatment of patients with peripheral arterial disease (PAD). Unfortunately, the effects of this procedure are short-term and there remains a high rate (40-70%) of restenosis (re-narrowing of the arteries). The purpose of this research study is to determine if the use of the catheter for the delivery of the study drug called paclitaxel, will prevent re-narrowing of the blockage of an artery to be treated in the leg.

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

Carotid Revascularization and Medical Management for Asymptomatic Carotid stenosis - Hemodynamics (CREST-H) Save

Date Added
January 31st, 2018
PRO Number
Pro00073070
Researcher
Christine Holmstedt

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart, Stroke
Summary

This is an ancillary study on the Phase 3 parent trial (CREST-2) in which patients with asymptomatic high grade carotid artery stenosis have enrolled to receive either a novel intensive medical management plan alone, or in combination with either Carotid Endarterectomy (CEA) or Carotid artery stenting (CAS). Patients enrolled in CREST-H will undergo a baseline MRI and some patients will also undergo a followup MRI at 1 year. The purpose is to determine whether cognition can be improved by revascularization among the subset of CREST-2 patients with hemodynamic impairment and mild cognitive impairment at baseline.

Institution
MUSC
Recruitment Contact
Cheryl Grant
843-792-7118
grantche@musc.edu

Diabetes, modified lipoproteins, and preeclampsia Save

Date Added
January 10th, 2018
PRO Number
Pro00070368
Researcher
Timothy Lyons

List of Studies

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Keywords
Cardiovascular, Diabetes, Hypertension/ High Blood Pressure, Pregnancy
Summary

Pre-eclampsia (PE) happens in pregnancy. It features new onset high blood pressure. It is a major cause of problems to the mother and unborn child. It can lead to health problems in mother and child in the future, which causes a public health problem. We do not know everything about it, but we think it starts in the placenta (the organ that nourishes the unborn child). At this time, we do not know who will get PE. We want to study the placenta, to learn more about the disease.

Institution
MUSC
Recruitment Contact
Misti Leyva
8437921933
leyva@musc.edu

AtRial Cardiopathy and Antithrombotic Drugs in prevention After cryptogenic stroke Save

Date Added
January 10th, 2018
PRO Number
Pro00072371
Researcher
Christine Holmstedt

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart, Hypertension/ High Blood Pressure, Stroke, Stroke Recovery
Summary

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban (Eliquis) versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. 1100 subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

Institution
MUSC
Recruitment Contact
Cheryl Grant
843-792-7118
grantche@musc.edu

A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF). Save

Date Added
January 3rd, 2018
PRO Number
Pro00065220
Researcher
Ryan Macnevin

List of Studies

Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.

Inclusion criteria:
?Male or female patient, age >= 18 years at screening.
?Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
?Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
?Stable dose of oral diuretics, if prescribed
?Signed and dated written ICF (informed consent form)
?Further inclusion criteria apply

Exclusion criteria:
?Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
?Heart transplant recipient or listed for heart transplant
?Acute decompensated HF (Heart Failure)
?Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
?Symptomatic hypotension and/or a SBP < 100 mmHg
?Indication of liver disease,
?Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
?History of ketoacidosis
?Treatment with any SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
?Currently enrolled in another investigational device or drug trial
?Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
?Women who are pregnant, nursing, or who plan to become pregnant while in the trial
?Further exclusion criteria may apply

Institution
Palmetto
Recruitment Contact
Ryan MacNevin
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients with, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Save

Date Added
November 28th, 2017
PRO Number
Pro00071912
Researcher
Pamela Morris

List of Studies


Profiles_link
Keywords
Cardiovascular, Cholesterol
Summary

The purpose of the study is to see if a new investigational drug called bempedoic acid reduces the risk of major cardiovascular (heart and blood vessel-related) events in patients with, or at high risk for, heart disease who have had complications related to taking statins. The study will compare bempedoic acid with a placebo to see if taking bempedoic acid is better than taking a placebo.

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

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