Active clinical trials for "Coronary Artery Disease"

Demonstrate in a large multicenter population the diagnostic performance of a pre-commercial on-site, local, CT angiography derived FFR algorithm in comparison to invasive FFR.

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.

Specific aim 1a will test the hypothesis that diabetic patients with 2-2 haptoglobin genotype have higher indices of postoperative myocardial injury (creatine kinase MB isoenzyme , Troponin I ) and renal injury (as indicated by elevated creatinine, cytostatin C and glomerular filtration rate). Of note, significantly elevated levels (>5 times the upper normal limit) of creatine kinase MB isoenzyme and troponins postoperatively have been associated with postoperative myocardial ischemia/infarction and are a predictor of short-term and long-term mortality after cardiac surgery. Specific aim 1b will evaluate preoperative and postoperative indices of oxidative stress (such as isoprostane f2 alpha and malondialdehyde) and will evaluate whether patients with type 2-2 haptoglobin express increased oxidative stress. The investigators will also try to correlate whether patients with increased oxidative stress are those with elevated indices of myocardial and/or renal injury Specific aim 1c will try to evaluate whether patients with type 2-2 haptoglobin also have increased levels of inflammatory indices (C-reactive protein,[interleukin] IL-1, IL-2, IL-6, TNF[tumor necrosis factor]) and try to correlate the findings with postoperative myocardial and or renal injury. The incidence of atrial fibrillation after coronary artery bypass graft ranges from 19% to 27%. The investigators will also look at any correlation of the type 2-2 haptoglobin and the incidence of post-operative atrial fibrillation.

This is a clinical trial to test the clinical feasibility and safety of a novel CMR protocol, combined with a specific breathing maneuver to identify myocardial regions exposed to severe coronary artery stenosis.

Effect of Preoperative Aspirin in patients undergoing Off-pump Coronary Artery Bypass Grafting. A double-blind, placebo-controlled, randomized trial.

This is a single centre observational study on the impact of change in patient position and hence gravity, on physiological measurements in coronary arteries. When patients present with heart attacks involving completely occluded heart arteries, there are signs anecdotally and in literature that arteries sitting higher up with the patient lying flat, receive less blood supply than arteries sitting lower down. The investigators believe this effect is due to the pull of gravity on the flow of blood through the heart arteries. If this is indeed the case, changing position from lying supine (patient on their back) to lying prone (patient on their front) could reverse these anatomical positions and change measurements obtained during a coronary angiogram. These measurements include pressure and flow.

Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries.

To detect and evaluate the predictors of graft patency after coronary artery bypass graft surgery as assessed by multi-slice CT coronary angiography validated by coronary angiography

Background: Cardiac rehabilitation is indicated for ischemic heart disease patients; the program content of which is well described in both European and American guidelines. In contrast, literature on cardiac rehabilitation program content and efficacy in the Asian population is sparse. Methods: BeSingCardioRehab will be an intercontinental, retrospective cohort study conducted in two cardiac rehabilitation referral centers in Belgium and Singapore. The first aim is to compare the impact of phase II center-based cardiac rehabilitation on Major Adverse Cardiac Events for ischemic heart disease patients between Europe (i.e. Belgian) and Asia (i.e. Singaporean) in the long-term. The second objective is to compare the efficacy of phase II cardiac rehabilitation on short-term morbidity (assessed with the validated SMART Risk Score) between index European and Asian ischemic heart disease patients. The level of compliance of the Belgian and Singaporean cardiac rehabilitation programs to European guidelines standards will also be evaluated. Hypotheses BeSingCardiorehab will be one of the first studies assessing cardiac rehabilitation in Asia. Based on the BeSingCardioRehab study results, phase II center-based cardiac rehabilitation programs, can/will be adapted in order to improve program content and outcomes.

The Axxess™ Biolimus A9™ Eluting Coronary Bifurcation Stent System (AXXESS System; Biosensors, International, Morges, Switzerland) is a dedicated bifurcation stent, designed to cover the lesion at the level of the carina. Although deemed ideal for lesions involving only the proximal MV (1,0,0 according to Medina classification ref), this device may be used also in more complex bifurcation lesions when additional DES are required in the distal MV and/or in the SB. In the present registry the investigators report the performance and the efficacy of the self-expanding biolimus-eluting AxxessTM stent for the treatment of bifurcation lesions in a real-world population.