Study of Hepatitis Eradication Receiving Protease Inhibitor Administration
Coronary Artery DiseaseMoralityThis is a prospective, non-blinded cohort study that will assess the safety, tolerability, and antiviral efficacy of glecaprevir/pibrentasivir therapy given post-discharge to HCV-negative recipients of HCV infected donors. Patients who meet entry criteria will be enrolled while on the transplant waitlist. At the time of transplant, some donors will be HCV positive / NAT positive and some will not be infected. Enrolled patients who receive an HCV negative donor will serve as contemporaneous controls. All study subjects who receive an HCV positive organ will be confirmed to have acquired HCV infection and genotype will be assessed prior to treatment with therapy.
Safety and Efficacy of DCB Therapy for de Novo Lesions Under the Guidance of QFR in CHD Patients...
Coronary Heart DiseaseSince Gruntzig successfully performed percutaneous coronary balloon angioplasty in 1977, percutaneous coronary intervention has developed rapidly. From bare metal stents to drug-eluting stents (DES), the symptoms and prognosis of patients with coronary heart disease (CHD) have been greatly improved. Although DES has reduced the probability of in-stent restenosis (ISR) and thrombosis compared with BMS since its clinical application, it can not completely solve this problem. Even if the new generation of DES requires revascularization, the incidence of ISR is still as high as 5%-10%. DES treatment is associated with delayed endothelial healing, late acquired poor stent adherence and new atherosclerosis, which lead to late ISR and thrombosis. In addition, DES is still not ideal for the treatment of small vessel disease, diffuse long lesion and bifurcation lesion. Therefore, drug coated balloon (DCB) has attracted people's attention. Balloon-loaded antiproliferative drugs can fully release the drugs to the vascular wall during balloon dilation, which can inhibit the restenosis process from the beginning of injury, and show good efficacy and safety in some specific lesions. Many clinical studies have shown that DCB has good efficacy and safety in some specific lesions (ISR, small vessel disease, bifurcation disease, in situ lesion). Especially in the treatment of ISR, researchers believe that its efficacy is not inferior to DES, and it has the advantage of non-metal residues. Quantitative flow ratio (QFR) is the second generation FFR detection method based on angiographic images. The diagnostic accuracy of QFR 0.80 for myocardial ischemic stenosis was 92.7%. Compared with QCA, the positive predictive value and negative predictive value of QFR were also significantly better than those of QCA. The latest FAVOR II results also confirm that QFR is more sensitive and specific in diagnosing myocardial ischemia caused by coronary artery stenosis than QCA, and confirm the feasibility of using QFR online in catheter lab to evaluate the functional significance of coronary artery critical lesions. However, there is no report on the treatment of de novo lesions in patients with coronary heart disease by DCB under the guidance of QFR. The aim of this study was to evaluate the safety and efficacy of drug balloon therapy for de novo lesions in patients with CHD under the guidance of QFR compared with DES implantation.
Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter...
Mitral Valve InsufficiencyCoronary Stenosis2 moreIn the present study, the investigators aim to use the in-vivo Transcatheter Mitral Valve Repair (TMVR) model to determine how Mitral Regurgitation (MR) affects coronary hemodynamics in patients affected with severe MR and concomittant angiographically-documented coronary artery disease. The investigators will also provide unique physiologic data on the acute effect of TMVR using the MitraClip system on coronary microcirculation in patients with severe MR.
Diastolic Hyperemia Free Index for Assessment of Moderate Coronary Stenoses
Coronary Artery DiseaseA total of 106 subjects will be enrolled at up to 3 sites. Initial enrollment will occur at Washington University only. After 15 subjects have been enrolled at the primary site and no serious adverse events or protocol events have occurred the additional sites will be trained and added to enrollment.
MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease
Coronary Artery DiseaseSafety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.
IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System...
Coronary StenosisCoronary Artery DiseaseThis is a prospective, multi-center, single-arm, open-label, early feasibility study to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system
Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)
Ischemic Heart DiseaseValvular Heart Disease2 moreIn order to perform heart surgery, a machine called cardiopulmonary bypass (CPB), or more commonly known as a heart-lung machine, is used to maintain the circulation of oxygenated blood needed by the rest of the body and its organs. Historically, when a patient is connected to CPB, their body is cooled below the normal body temperature. This is known as hypothermia. This is because scientific studies have previously shown that reduced body temperature lowers metabolism and therefore offers more protection to the brain and other organs due to the reduced oxygen requirement. The evidence supporting this practice, however, has been challenged throughout the history of cardiac surgery, with studies supporting that normothermia, or normal body temperature, is a safe alternative. Despite this, the practice of hypothermia has persisted. Published data from a survey of 139 cardiac surgeons in the United Kingdom showed that 84% still routinely employ hypothermic CPB during surgery. To assess whether normothermic or hypothermic CPB is safer, a clinical trial requiring a large sample size and high recruitment rates will be required. Therefore, the investigators aim to assess firstly the feasibility of trial recruitment and allocation adherence in this study. 100 adults across 10 different cardiac surgery centres in the United Kingdom will be recruited to a multicentre feasibility randomised controlled trial comparing normothermia (active comparator) against hypothermia (control comparator) during cardiopulmonary bypass in cardiac surgery. This study will also test the ability of the Cardiothoracic Interdisciplinary Research Network (CIRN), a trainee-led research collaborative, to collect pilot data on Major Adverse Cardiac and Cerebrovascular Events (MACCE) using a regulation-approved electronic application HealthBitⓇ. Participants will also be asked to complete quality of life surveys. The results of this study will subsequently inform a large, adequately powered randomised controlled trial for optimal temperature management during CPB.
A Validation Study of Nitroglycerin Induced Acute Drop of Pd/Pa (NTG-Pd/Pa) in Clinical Practice...
Hypotension SymptomaticIschemic Heart DiseaseHyperemia with adenosine was an elemental process in FFR examination. Adenosine injection will induce some discomfort, and increase cost expenditure. Nitroglycerine will induce an acute drop of Pd/Pa, and this lowest Pd/Pa was determined as NTG-Pd/Pa. NTG-Pd/Pa has a linear relationship with FFR value and has a good diagnostic accuracy to predict FFR≤0.80 in our recent study. There is only one prospective study report on the relationship between NTG-Pd/Pa and FFR. In this study, we aim to evaluate the safety of NTG-Pd/Pa, the repeatability and dose-response of this novel index. Furthermore, we will investigate the diagnostic accuracy of NTG-Pd/Pa, with FFR≤0.8 and Resting full-cycle ratio≤0.89 as ischemic threshold respectively.
Cardiac Markers in Depressed Patients With Coronary Heart Disease - R01HL147862
Coronary Heart DiseaseDepressionDepression doubles the risk of death in patients with coronary heart disease (CHD), but so far, there is insufficient evidence that we can reduce the risk of death by treating depression. This study will investigate the cardiac risk markers that are associated with depression symptoms that remain despite treatment, and identify potential targets for their treatment. The results of the study will inform the development of more effective interventions to improve both depression and survival in patients with CHD.
Pressure-Volume Loop During High-Risk PCI
Coronary Artery DiseaseThis study will examine the physiologic effects on loading conditions and contractility of the left ventricle during high-risk primary coronary intervention (HRPCI) in the Cardiac Cath Lab. This will be performed through analysis of real-time left ventricular (LV) pressure-volume loops (PVL) by continuously recording PVL during HRPCI with the Inca® Pressure-Volume Loop System that will be temporarily placed in the left ventricle during the procedure.