Active clinical trials for "Coronary Disease"

This is a prospective, multi-center registry to evaluate safety and effectiveness of the Everolimus Drug Eluting Stent for treatment coronary revascularization in Chinese patients with long lesion, small vessel or multi-vessel diseases.

Percutaneous recanalization of total coronary occlusions (TCO) was historically hampered by high rates of restenosis and reocclusion. In the PRISON II and III trial we showed landmark reduction in restenosis with sirolimus-eluting stents (Cypher, Cordis Corporation) compared to conventional bare metal stents in TCO. In the PRISON III trial, we observed similar favourable results with second-generation zotarolimus-eluting stent (Resolute, Medtronic Inc.). Another drugs-eluting stent mounted with everolimus (Xience Prime, Abbott) also demonstrated favourable results in TCO. Recently, drug-eluting stents (DES) with bioresorbable polymer coatings were developed, to address safety concerns regarding the observation of very late stent thrombosis, due to hypersensitivity reactions, and chronic inflammation, on the durable polymer coating of DES. However, none of these DES with bioresorbable polymers were evaluated in patients with TCO. The PRISON IV trial is a prospective, randomized, single-blinded, multi-center trial, designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (ORSIRO, Biotronik Inc.) compared to everolimus-eluting stents with durable polymers (Xience Prime, Abbott) in patients with successfully recanalized TCOs.

Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.

The field of secondary prevention remains an extremely important goal for diagnostic and therapeutic approaches keeping in mind that 40% of all patients with acute myocardial infarction have prediabetes, commonly as impaired glucose tolerance, which has not been known and treated and for which there are no guidelines for treatment. In this context, accumulating evidence shows beneficial effects for treating diabetes mellitus early in the course of disease, whereas other evidence shows that aggressive antidiabetic therapy may be associated with undesired risks. Accordingly, the present randomized and controlled pilot study is designed as hypothesis creating study to create first data about potential medication in early type 2 diabetes including impaired glucose tolerance of patients with known coronary artery disease as means of secondary prevention by comparing oral antidiabetic therapy with metformin with insulin glargine o.d. and by studying the respective effects on cardiovascular function and metabolism both in the fasting state and after a standardized meal. As diastolic myocardial function has emerged as important prognosticator, the hypothesis was tested that treatment with insulin glargine improves myocardial function in patients with coronary artery disease and newly diagnosed type 2 diabetes including impaired glucose tolerance.

Restenosis due to neointimal hyperplasia causes repeat target vessel revascularization in a relevant number of patients undergoing percutaneous coronary interventions (PCI). Drug-eluting stents (DES) are currently adopted to reduce the rate of restenosis; however, they may increase risk of stent thrombosis. Experimental data and first clinical experiences showed that inhibition of neointimal hyperplasia may be obtained by local administration of anti-proliferative drugs (like paclitaxel) loaded on the surface of angioplasty balloons. Data on the efficacy of novel coronary drug-eluting balloons (DEBs) are lacking. Aims of this open label prospective, randomized trial is to evaluate neointimal hyperplasia in patients undergoing bare-metal stent (BMS) implantation alone compared to those receiving additional DEB use and to assess if the technique of DEB use may affect the degree of neointimal hyperplasia. Neointimal hyperplasia will be assessed by Optical coherence tomography (OCT).

The experimental design is a multi-center, prospective, non-controlled, non-randomized, single-arm clinical registry trial. The study will enroll 5,000 patients who receive the Firebird2TM Cobalt-ChromiumAlloyed Sirolimus-Eluting Stent implantation. For patient with multivessel disease, only Firebird 2TM Stent will be implanted. The enrollment of patients will take about 4 months. Clinical follow-up will be at 30 day, 6 month, 12 month, 24 month and 36 month. Patients withdrawing the study due to any reasons will not be replaced.

The objective of this trial is to investigate the effect of early treatment of glucose toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of cardiovascular events and the inhibition of atherosclerosis.

The aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications

Study title:A Study for Testing Safety and Efficacy of the administration of Blood-Borne Autologous Endothelial Progenitor Cells to Alleviate Anginal Symptoms and Myocardial Ischemia in Patients with Severe Anginal Syndrome Principle Investigator: Assoc. Prof. Damras,Tresukosol,M.D.,Head of Cardiac Catherlization unit,Division of Cardiology,Department of Medicine,Faculty of Medicine Siriraj Hospital,Mahidol University Study objective : To determine the safety and efficacy of intracoronary injection of blood-borne autologous EPCs in relieving symptoms of angina pectoris in symptomatic patients treated with maximal medical therapy with an occluded coronary artery supplying ischemic myocardium Study Design : Phase II, a single center,a non-randomized,open-label trial, Study population : Total expected no. of patients : 24 main selection criteria : Patients with chronic stable angina on maximal medical therapy and an occluded coronary artery supplying an ischemic viable myocardial region as shown on Sesta-mibi scan. On coronary angiography,the occluded coronary artery must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the EPC if the vessel remains occluded despite the attempted angioplasty efforts. Age 18-80 years Ejection fraction >35 % on Sesta-mibi scan Sestamibi scan (myocardial perfusion) during exercise or dipyridamole,demonstrating regional reversible ischemia in an area relating to the occluded coronary artery. Investigational Product : At D-8 250 ml of blood drawn from the patients for production of autologous EPCs or ACPs (VescellTM), On D0 ,at least 1.5 million EPCs with viability >75 % suspended in 6 ml sterile cell culture medium will be injected to the same patients by intracoronary artery. The study consists of 4 periods:Screening ( D-14to-9&D-8,Treatment(D0),Acute Safety follow-up (D1&D2),Chronic follow-up (D30,D90&D180)period ,total follow-up of each case is 6 months. Evaluation criteria : Safety : no.& duration of adverse event & serious adverse event Efficacy : change from baseline to 1,3,6 months of CCS, 6-minute walking test change from baseline to 3 & 6 months of Sesta-mibi scan change from baseline to 3 & 6 months of symptom-limited exercise time,exercise-induced ischemia & METs on Sesta-mibi scan Duration of study: July 2004-December 2006

The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.