View clinical trials related to Coronary Artery Disease.
Filter by:The MyoVista system is a novel electrocardiogram technology that provides non‐invasive assessment of myocardial abnormalities by analyzing energy changes at the cellular level of the myocardium.
Prospective, multi-center, registry designed to enrol up to 2,000 patients in up to 35 International centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial.
The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES, in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment of coronary artery disease.
Heart Failure has several etiologies and one of them is coronary artery disease. Coronary artery bypass grafting (CABG) is one of revascularizations method which has been used for decades in coronary artery disease theraphy. However, data about coronary artery bypass grafting shows that post-CABG patients still have low ejection fraction. For the last decade, there have been a lot of studies about the using of stem cells to increase heart contractility and reverse the heart remodelling process. In this study, we use CD 133+ bone marrow stem cells which has been proved to have higher angiogenesis potential. The stem cells is given during CABG by injection transepicardial and transseptal. The purpose of this study is to determine whether transpicardial and transseptal injection of CD 133+ bone marrow stem cells can improve myocardial perfusion in patient with low ejection fraction following CABG surgery.
The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.
The aim of this study is to test for an early post-stress cardiac output (CO) change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (CZT) SPECT camera.
Uric acid is a risk factor for coronary artery disease (CED) in postmenopausal women but the association with inflammation and coronary microvascular endothelial dysfunction is not well-defined. The aim of this study was to determine the relationship of serum uric acid, inflammatory markers and CED.
Background: The best strategy for ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) in the acute phase with remaining multivessel disease, is still not well established. Current guidelines recommend PCI of only the infarct related artery (IRA). However, recent small scale randomised controlled trials indicate that full revascularization of these non-infarct related arteries during the index procedure is superior to initial conservative treatment. Fractional flow reserve (FFR), a method used to determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI in stable angina. Objective and methods: To test the hypothesis that a strategy of systematic complete revascularization with FFR-guided PCI following STEMI/very high risk NSTEMI leads to improved clinical outcomes compared to initial conservative management of non-culprit lesions. The trial is a prospective international multicentre registry-based randomized controlled trial with combined primary endpoint of all-cause mortality, or non-fatal MI, or unplanned revascularization at a minimum follow-up of 2-3 years. The first key secondary endpoint is the combined endpoint of all-cause mortality or myocardial infarction. The second key secondary endpoint is unplanned revascularization. 1542 patients with acute STEMI/very high risk NSTEMI with multi-vessel disease in Sweden, Denmark, Serbia, Finland, Latvia, Australia and New Zealand will be randomized into 2 arms: 1. FFR-guided PCI of non-culprit lesions during index hospital admission or 2. Initial conservative management following acute PCI of the culprit lesion(s) or Randomization and data collection in the registries - the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and corresponding registries in other countries (or electronic data capture) - will ensure low bias, high inclusion rate and excellent follow-up of events at a low cost. Adjudication of clinical events and collection of data from other registries including death cause registries is also planned. Significance: If this study shows that FFR-guided PCI of non-culprit lesions in STEMI/very high risk NSTEMI improves clinical outcome compared to conventional management this will change practise in how we should best manage these patients. Therefore a study of this size will definitely be of great importance in determining future guidelines for this large patient group to reduce both morbidity and mortality.
This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary artery disease after percutaneous coronary intervention with the newer drug-eluting stent.
AIM OF THE STUDY: The aim of the present registry is to investigate the procedural as well as the long-term clinical results in terms of safety and efficacy of the polymer-free DES technology in all comers patients with an indication to percutaneous coronary intervention. PRIMARY SAFETY ENDPOINTS: the cumulative hierarchical incidence of major adverse cardiac events (MACCE) defined as: cardiac death, non-fatal myocardial infarction (MI), stroke and ARC-defined stent thrombosis (18) at any time point and bleeding defined according to BARC classification (19). PRIMARY EFFICACY ENDPOINTS: clinically driven target lesion revascularization (TLR). STUDY DESIGN: multicenter (presumably 10 centers across the Italian territory), prospective observational registry aiming to enroll a population of 1000 patients. STUDY DURATION: We project 12 months for recruitment, 5 year follow-up duration after last patient in the registry. CLINICAL FOLLOW-UP PLAN: 30 days, 3, 6, 9 months, 1 year, and then yearly up to 5 years after the index procedure. PATIENTS SELECTION CRITERIA: This is an "all comers" registry and patient who will be enrolled have to meet the sequent criteria: - Patient must be at least 18 years of age at the time of signing the Informed Consent Form after Biofreedom placement. - All "de novo" lesion subsets are included. - Patient must agree to undergo all required follow-up visits and data collection. - Patient must have indication to percutaneous coronary intervention following: - Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or - Unstable angina / non ST-elevation myocardial infarction - ST-elevation myocardial infarction with de novo culprit lesion. EXCLUSION CRITERIA: The exclusion criteria must follow the most recent IFU which may include but are not limited to the following: - Known intolerance to any of the device components - In-stent restenosis - Woman with childbearing potential - Age < 18y/o - Inability to provide written informed consent EFFICACY PARAMETERS: TLR and TVR up to 5-year follow-up. SAFETY "PATIENT ORIENTED" PARAMETERS: all cause mortality, any myocardial infarction, Stent thrombosis based on the ARC classification, up to 5-year follow-up and bleeding occurrence according to BARC classification. Data on dual antiplatelet therapy use will also be collected and analyzed according to duration and cessation modalities. Sample size justification: Being this an observational registry aiming at quantifying effect estimates without direct comparisons to other devices for coronary angioplasty, we relied on confidence interval profiling for sample size justification, without proceeding with formal power analysis. The main analysis will be an overall and comprehensive analysis and it will be planned the primary analytical approach of all-comers patients with coronary artery disease and indication to PCI. Accordingly, we computed that a target sample of 1000 patients will enable the computation of reasonably precise 95% confidence intervals. Specifically, assuming a 8% MACE rate at 1 year (in keeping with RUDY study and LEADERS FREE trial design), confidence intervals computed with the adjusted Wald method would be 7.1% to 9.6% for a 1000-patient sample (point estimate 80/1000 [8.0%]). Given that the registry aims to reflect real-world patients and practice, no prevision to limit or restrict patient enrollment is considered. Analytical plan: Continuous endpoints will be summarized by presenting the total number of patients, mean, standard deviation, median, minimum, and maximum. Tabulation of categorical parameters will include counts and percentages. The outcomes will be summarized as both a discrete and a continuous variable using the method described above. Survival analysis will be performed with the Kaplan-Meier method. Statistical inference will be based on the computation of 95% confidence intervals using the adjusted Wald method. Additional analyses will involve key subgroups defined according to baseline, lesion, and procedural features, with statistical significance set at the 5% 2-tailed level. Specifically, Student t, Fisher exact, and log-rank tests will be used for such bivariate analyses, whereas multivariable linear regression, logistic regression, and Cox proportional hazard analyses will be used to adjust for confounders.