Short-term Endothelin A Receptor Blockade in Patients With On-pump CABG
Coronary Artery DiseaseAorto-coronary Bypass GraftingBackground: Although selected cardiac surgery can be performed off-pump, the vast majority of cardiac surgical procedures today are performed with the support of cardiopulmonary bypass (CPB). Blood cardioplegia is used to protect the heart during aortic cross-clamping. However, negative effects of myocardial hypoxia during surgery are often aggravated by ischemia/reperfusion injury. In addition, cardiopulmonary bypass leads to an inflammatory response including endothelial cell activation. Comparable to the reperfusion injury following acute myocardial infarction resolved by percutaneous coronary intervention, the microcirculatory impairment observed after cardiac surgery may be caused by endothelin 1 (ET-1). ET-1 is a potent vasoconstrictor peptide upregulated in myocardial ischemia-reperfusion injury. Short-term administration of the selective ETA receptor blocker BQ-123 was found safe in a pilot study including patients with acute myocardial infarction. Hypothesis: Acute local ETA receptor blockade by intracoronary administered BQ-123 reduces myocardial injury. Methods: BQ-123 will be administered in patients undergoing on-pump aorto-coronary bypass grafting to the left anterior descending coronary artery with the use a left inner mammary artery graft and at least one vein graft. Subjects will be randomized to receive the endothelin-A receptor blocker BQ-123 or placebo administered intracoronarily in combination with cardioplegia in a double-blind manner. The primary endpoint will be enzymatic infarct size. Clinical perspective: The implementation of BQ-123 as an add-on pharmacologic therapy in cardiac surgery performed with the use of cardiopulmonary bypass could lead to improved tissue reperfusion and reduced ischemia/reperfusion injury, potentially impacting clinical long-term outcome.
Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients
Coronary Artery DiseaseTreatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects. Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). It remains unknown, however, which of these two therapeutic approaches is more effective after PCI. The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty
Ischemic Heart DiseaseWhether to revascularize patients with angiographically-intermediate coronary lesions (AICL) is a major clinical issue. Intravascular techniques (assessing either the anatomy or the functional effect of coronary stenoses) are routinely used to better characterize coronary lesions. Among these,fractional flow reserve (FFR) provides validated functional insights while optical coherence tomography (OCT) provides high resolution anatomic imaging. Both techniques may be applied to guide decisions regarding the opportunity to revascularize patients with AICL and to optimize the result of percutaneous coronary intervention (PCI). We aim to compare the clinical and the economical impact of FFR versus OCT guidance in the percutaneous management of patients with AICL.
Epicardial Fat and Clinical Outcomes After Coronary Artery Bypass Grafting in Diabetics vs. Non...
DiabetesCoronary Artery DiseaseCardiovascular disease (CVD) is a group of diseases including both the heart and blood vessels, thereby including coronary heart disease (CHD). To date, diabetics have a higher incidence and prevalence of multivessels CHD. Treatments in multivessels CHD in diabetics include full medical anti ischemic therapy, and revascularization therapy (Percutaneous coronary intervention (PCI) and/or Coronary artery bypass grafting (CABG)). Randomized trials comparing multivessel PCI to CABG have consistently demonstrated the superiority of CABG in reducing mortality, myocardial infarctions and need for repeat revascularizations. After the CABG treatment, diabetics vs. non-diabetics evidenced a worse prognosis, and an increased mortality. Numerous molecular, epigenetics (as microRNAs), and other metabolic risk factors may condition the worse prognosis in diabetics vs. non diabetics after CABG. In this context, an increased epicardial fat tissue thickness may be independently associated with the prevalence of diabetes, and diabetics have an higher epicardial fat tissue thickness, volumetry, and enhanced metabolism. Therefore, after CABG, lifestyle and medical improvements may lead to the reduction of epicardial fat thickness, extension, and metabolism in both non-diabetics, and diabetics, ameliorating the prognosis. At moment, epicardial tissue function in diabetics is not well investigated in literature, and no data has been reported about new hypoglycemic drugs, and its pleiotropic effects on diabetics after CABG. Indeed, our study hypothesis was that, epicardial fat tissue dimension, and metabolic activity may be related to a different expression of inflammatory, oxidative, and apoptotics molecules, and epigenetic effectors in diabetics vs. non-diabetics. Secondary, these effectors, and epicardial tissue dimension and activity, may be controlled, after CABG, by incretin treatment in diabetics. Therefore, incretin therapy may be associated to the reduction in epicardial fat tissue thickness, and extension, with down regulation of different inflammatory, oxidative and apoptotics molecules, and epigenetic effectors involved in epicardial fat metabolism. Moreover, in this study authors will evaluate in diabetics vs. non diabetics, and in diabetic incretin-users vs. never.-incretin-users, all cause mortality, cardiac mortality, and Major adverse cardiac events (MACE) after CABG in diabetics vs. non diabetics, and diabetic incretin-users (6 months of incretin therapy) vs. diabetic never-incretin-users. Authors will correlate these clinical endpoints to the study of the epicardial fat anatomy and metabolism before and after CABG, and to circulating inflammatory and pro-apoptotic markers, epigenetic effectors, and stem cells in diabetics vs. non diabetics, and diabetic incretin-users (6 months of incretin therapy) vs. diabetic never-incretin-users.
Effects of SGLT2 Inhibitor in Diabetic Patients With Coronary Artery Disease
Coronary Disease With Diabetes MellitusThe aim of this study is to explore the effect of newly added SGLT2I medication or placebo, to standard medication regimen in diabetic patients with documented stable coronary disease. Therefore, in the present study the investigators plan to focus on possible anti-inflammatory and athero-thrombotic protective effects of Dapagliflozin compared to placebo, in secondary prevention population of stable coronary patients with diabetes. Additionally, the investigators will explore NT proBNP dynamics, which related to ventricular filling pressures in this specific population.
STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion
Chronic Total OcclusionCoronary Artery DiseaseIntro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment of CTO with percutaneous coronary intervention (PCI) is associated with good clinical outcomes. However, QCA and IVUS studies showed a notable lumen and vessel enlargement distal to recanalized CTO. In addition, optical tomography (OCT) studies showed high rates of stent strut malapposition and incomplete stent strut coverage after CTO PCI. The Stentys Xposition S is a self-apposing stent device which lowers stent strut malapposition rates. Its safety and effectiveness has been demonstrated in STEMI and stable coronary patients but never investigated in CTO lesions. Hypothesis/Objective To investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 6 months after implantation in patients with CTO undergoing percutaneous coronary intervention. Method Pilot randomized study. Patients are randomized to receive either self-expandable stent or balloon expandable stent to perform CTO-PCI. Follow-up coronary angiography is performed at 6 months post-PCI. Stent malapposition is evaluated by OCT.
Clinical Effect of No-touch Harvesting Technique in OPCABG
Coronary Artery DiseaseGraft FailureThis study aims to investigate the clinical effect of the new saphenous vein harvesting technique "No-touch" in off-pump coronary artery bypass grafting(OPCABG), comparing to the conventional technique. Adopting CTA to evaluate the 3 months patency of the graft, we will compare veins harvested using No-touch technique to saphenous veins using conventional open technique.
The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation
Atrial FibrillationIschemic Heart DiseaseThe aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.
Low Intensity Resistance Training With Vascular Occlusion in Coronary Heart Disease Patients
Coronary DiseaseCoronary Artery DiseaseIn our clinical controlled trial, patients with coronary heart disease will be randomly assigned into the exercise intervention (low intensity resistance training with vascular occlusion) or usual physical activity group (control group).
Curative Effect Evaluation of Danlou Tablet on Coronary Artery Disease Not Amenable to Revascularization...
Coronary Artery Disease(CAD)The purpose of this study is to determine whether Danlou Tablet is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.