QuidelOrtho, Inc. / "The 99th Percentile Upper Reference Limit for the TriageTrue High Sensitivity Troponin Test"

Date Added
February 28th, 2024
PRO Number
Pro00134743
Researcher
Gary Headden

List of Studies


Keywords
Cardiovascular
Summary

This is a study designed to determine the 99th percentile upper reference limit (URL) for the Quidel
TriageTrue® hs-Tnl Test (TriageTrue) in whole blood and plasma.
The study will enroll apparently healthy adults. Potential subjects will be pre-screened for
eligibility using a questionnaire to assess comorbidities, chronic conditions, and medication use.
Those with comorbidities or chronic conditions that potentially affect the heart will not be eligible,
nor will those who are prescribed medications related to cardiovascular disease or risk factors.

Institution
MUSC
Recruitment Contact
Alexa Rubenstein
18436931860
rubenste@musc.edu

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Date Added
January 9th, 2024
PRO Number
Pro00132012
Researcher
Daniel Silverman

List of Studies

Keywords
Cardiovascular, Heart
Summary

The purpose of the study is to evaluate the safety and how well the medication levosimenden works versus placebo in treating Pulmonary Hypertension and Heart Failure with a Preserved Ejection Fraction measured by a 6 minute walk. This is a condition where the lower left chamber (left ventricle) of the heart is not able to fill properly with blood during the filling phase and the amount of blood pumped out to the body is below normal. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Levosimendan is a drug that has been FDA-approved for intravenous (IV) delivery to your body. This study aims to determine if the tablet form of the drug is as effective as the IV route. Tablets are much more attainable for patients to manage their heart failure from home, rather than going to an infusion clinic for treatments. Participation in this study will last approximately 12 weeks with the option to continue to the stage 2 phase of the study. If the stage 2 phase is selected as well, participation will last approximately 26 months or a little over 2 years. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks.

Participants will be randomized to either the treatment group (and receive the medication) or the control group (receive an inactive medication). Subjects will have a 50:50 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Shaquanda Ross-Simmons
843-876-5783
shr37@musc.edu

Seroprevalence Study of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV) in Patients with Plakophilin 2 (PKP2)-associated Arrhythmogenic Right Ventricular Cardiomyopathy(ARVC)

Date Added
January 5th, 2024
PRO Number
Pro00132416
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to collect information about patients with Arrhythmogenic right ventricular cardiomyopathy(ARVC) and about the disease. ARVC is a rare condition that affects heart muscle and causes abnormal heart rhythms (this is called "arrhythmia"). Participation in this study will take about 5 years. If your study doctor determines you are eligible and you agree to participate, you will be asked to visit the study doctor's office as part of your regular care for a screening visit and about 1 time each year for the length of the study. The majority of the data collected for this study will be part of your regular care, however study related procedures include arrhythmia monitoring, using wearable devices to measure tracing of the electrical activity of your heart, blood work, including genetic testing, and patient questionnaires

Institution
MUSC
Recruitment Contact
Sam Moody
843-876-9558
moodysa@musc.edu

Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)

Date Added
December 1st, 2023
PRO Number
Pro00132788
Researcher
Anbukarasi Maran

List of Studies


Keywords
Cardiovascular, Women's Health
Summary

This observational study is enrolling women only who are undergoing a heart catheterization with planned percutaneous coronary intervention (PCI) using the Shockwave . A heart catheterization is a procedure in which a long thin tube called a catheter is directed through an artery to your heart, to look for blockages in the heart arteries. If there is a blockage that needs opening, a PCI can be performed to open the blockage. This study involves collecting data only from women participants who undergo a heart catheterization and PCI using the Shockwave IVL System. IVL stands for intravascular lithotripsy. The Shockwave IVL System is approved for use and commercial sale by the Food and Drug Administration. (FDA). Participation in this study will take about 3 years. Participants will be seen before the procedure, during the procedure, before hospital discharge following the procedure, and then seen in clinic or contacted by phone at 30 days, 1,2 and 3 years. This study will collect data from each of these visits including demographic data, medical history and medications, lab results, ECG results, procedure details, and any complications if applicable.

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

Abbott Ventricular Tachycardia Post Approval Study

Date Added
October 24th, 2023
PRO Number
Pro00132390
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Cardiovascular
Summary

This study is enrolling subjects who are scheduled for a ventricular tachycardia (VT) ablation. Ventricular tachycardia is a fast heartbeat that starts with an abnormal signal in the lower chambers of the heart, which are the ventricles. An ablation is a procedure where a catheter (thin, flexible tube) with a tip that can deliver energy is used to burn the heart tissue where those abnormal signals are coming from. The catheter being used in this study is called the FlexAbilityTM Ablation Catheter and was recently approved for commercial use by the Food and Drug Administration. (FDA) Since it is newly approved, the FDA wants to continue collecting more information about the catheter and its use, so this study is called a post approval study. Participation in this study will take about 1 year. During this year, data will be collected including your medical history, cardiac medication use, ablation procedure, and any medical events that may occur. You will be seen or contacted 4 times. There is a risk of loss of confidentiality and there may be risks that are not yet known. There may be no direct benefit to you but it is hoped the information learned may contribute to knowledge in this field.

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

Social Determinants of Health, Stress, Coping, and Quality of Life in Parents of Children with Congenital Heart Disease

Date Added
October 5th, 2023
PRO Number
Pro00131932
Researcher
Lianne Cole

List of Studies

Keywords
Cardiovascular, Children's Health, Heart, Mental Health, Pediatrics, Stress Disorders
Summary

This study will investigate the relationships among social determinants of health (SDOH), perceived stress, coping, and quality of life (QoL) in parents of children with congenital heart disease (CHD). Surveys will be administered to assess perceived stress, coping strategies, QoL, and SDOH. Semi-structured interviews with parents of children with CHD will explore parent experiences with CHD-related stressors, current use of coping strategies, SDOH barriers and facilitators to effective coping, and preferences for future interventions to reduce stress and facilitate coping.

Institution
MUSC
Recruitment Contact
Lianne Cole
336-207-8043
lianne.cole@childrens.harvard.edu

Fontan Udenafil Exercise Longitudinal Assessment Trial (the FUEL-2 Study)

Date Added
October 2nd, 2023
PRO Number
Pro00130325
Researcher
Andrew Atz

List of Studies


Keywords
Adolescents, Cardiovascular, Drug Studies, Pediatrics
Summary

This will be a 26-week, prospective, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study of udenafil 87.5 mg tablets versus placebo (both taken twice daily in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption [VO2] (mL/kg/min).

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-876-5203
alsarral@musc.edu

A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

Date Added
September 12th, 2023
PRO Number
Pro00131432
Researcher
Jessica Atkins

List of Studies

Keywords
Cardiovascular, Heart
Summary

This study is for patients with obstructive hypertrophic cardiomyopathy (oHCM). oHCM is a condition where the heart muscle becomes abnormally thickened, which can sometimes block the blood flow out of the heart and results in the heart muscle working harder to pump blood to the body.

The study is done to compare the side effects and effectiveness of an investigational (not yet approved by the Food and Drug Administration (FDA)) medication with the beta-blocker metoprolol succinate in participants with oHCM. The study medication is known as Aficamten and is a tablet taken by mouth. This is a randomized study (participants will be assigned by chance to the study medication Aficamten and placebo or metoprolol succinate and placebo). A placebo looks just like the study medication but has no active ingredient in it. The medications will be administered in the form of a pill. This study will take about 9 months and include about 11 visits to the study site. Study related procedures include blood work, echocardiograms (ultrasound test of the heart), electrocardiogram (recording of heart's electrical activity), exercise testing, physical exams, questionnaires and optional genetic testing. Risks associated with this study include shortness of breath, nausea, diarrhea, headaches and dizziness.

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



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