Active clinical trials for "Coronary Disease"

Since the development of percutaneous coronary intervention (PCI) in patients with coronary heart disease (CHD), unfractionated heparin (UFH) and low molecular weight heparin (LWMH) have been the preferred anticoagulants in peri-operative period. However, UFH has some defects, such as incomplete and unstable inhibition of thrombin, large individual differences, multiple monitoring of activated coagulation time (ACT), ineffective thrombin binding to fibrin, non-specific protein binding and induced thrombocytopenia (HIT). Compared with UFH, LWMH has lower non-specific protein binding rate, but it is not superior to UFH in efficacy, hemorrhage and HIT. Bivalirudin can bind specifically to thrombin catalytic site and anionic external binding site, directly inhibit thrombin activity, thereby inhibiting thrombin-catalyzed and induced reactions. At the same time, thrombin can also inactivate it by enzymatic hydrolysis of bivalirudin. Therefore, the inhibition of bivalirudin on thrombin is reversible and transient, and the risk of bleeding after drug withdrawal is relative small. It has been reported that bivalirudin can significantly reduce the risk of peri-operative bleeding during PCI period compared with UFH. Clopidogrel had not yet played a role in most patients after emergency PCI, and there was a "blank period" for 2-4 hours without effective antithrombotic concentration, which was also the peak period of acute stent thrombosis. Han and coworkers have shown that for acute myocardial infarction (AMI) patients undergoing emergency PCI, whether or not glycoprotein IIb/IIIa inhibitors were added, prolonged peri-operative use of bivalrudin was significantly better than UFH in terms of net clinical adverse event. However, for patients with elective PCI (ePCI), prolonged bivalirudin use was only used in some patients in REPLACE-2 and ISAR-REACT-3 studies, and the prolonged time of bivalrudin use after ePCI was not definite. Therefore, in the current study we aim to explore the efficacy and safety of prolonged bivalirudin use 4 hours after elective PCI in patients with CHD.

This study evaluates the addition of the CADScorSystem to a standard Diamond-Forrester score guided rule-out strategy in ambulatory patients referred with symptoms suggestive of stable coronary artery disease. Half of the patients will undergo stratification using a Diamond-Forrester score only, while the other half will undergo stratification using a Diamond-Forrester score and a CAD-score. The study hypothesis is that the addition of a CAD-score will reduce unnecessary testing without compromising patient safety.

Benefits from cardiac rehabilitation (CR) programs are evidence based and widely recognized. Less than 50% of people who participate in hospital-based CR programs maintain an exercise regimen for as long as six months after completion. Despite the benefits associated with regular exercise training (ET), adherence with supervised exercise-based CR remains low. Current exercise guidelines for CR focus on moderate intensity steady state exercises, with walking and cycling being the most recommended types of ET. The repetitive nature of this type of activity can become monotonous for the patient, affecting exercise adherence, compliance and training outcomes. Exercise periodization is a method typically used in sports training, but the impact of periodized exercise to yield optimal beneficial effects in cardiac patients is still unclear. In healthy or trained populations, periodization aims to optimize ET adaptations as compared with non periodized training, to prevent overtraining and to avoid plateauing of training adaptations. Periodized methods are considered to be superior to non periodized methods in trained populations and appears to be superior in inactive adults. In most of the CR programs there are no periodization or exercise progression during medium to long term interventions. Further randomized controlled trials (RCT) are necessary to evaluate long-term periodization outcomes. The purpose of this research project is twofold: To conduct a 12-month randomized control trial to evaluate the effects of a periodized ET regime versus a non periodized ET regime (guidelines) on VO2 peak, maximal strength, body composition, functionality and quality of life in cardiovascular disease patients. to differentiate the effects of a 12-month periodized ET regime versus a non periodized ET regime on the different components of the oxygen kinetics response and oxidative adaptations in cardiovascular disease patients. These patients will be randomized in 2 ET groups: 1) periodization; 2) non periodization. This experimental design will occur during 48 weeks 3 times per week with 4 assessment time points: M0) before starting the ET program (baseline); M1) 3 months after starting the ET; M2) 6 months after starting the ET program and M3) 12 months at the end of the community-based ET program.

Treatment of ischemic myocardium has been the subject of intense research in recent years and stem cell therapy is one of the great promises. The InCor laboratory has studied cells from different backgrounds as candidates for cell therapy in the context of myocardial infarction. Evidence in preclinical studies of the application of stromal (mesenchymal) adipose tissue (hASC) in the ischemic heart by both the InCor group (in the animal model in rodents and pigs) and others in the literature suggest relevant benefits on the decrease of deterioration post-infarction. More recently it has been demonstrated that it arises mainly from the formation of new vessels due to paracrine factors, which are secreted by the injected cells. There are currently no studies in Brazil in which the safety of injecting different doses of hASC cells into the heart has been particularly evaluated. Recently, two studies have demonstrated the clinical applicability of hASC in patients with peripheral ischemic disease and stroke. Thus, the objective of this work will be to test the hypothesis that the implantation of autologous stromal cells derived from adipose tissue combined with myocardial revascularization surgery in patients with coronary artery disease

Background: Office blood pressure (OBP) is used for diagnosing and treating hypertension but ambulatory blood pressure measurement (ABPM) associates more accurately with patient outcome. The optimal blood pressure in patients with coronary artery disease (CAD) is still unknown. Our objective was to investigate whether physician awareness of ABP after percutaneous coronary intervention (PCI) improved BP-control. Methods: A total of 201 patients performed ABPM before and after their PCI follow-up visit. Patients were randomized to open (O) or concealed (C) ABPM results for the physician at the follow-up visit. The change in ABP and antihypertensive medication in relation to baseline ABP was compared between the two groups.

Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been specifically studied for Drug Eluting Stents. The angiographically versus IVUS optimization (AVIO) study was performed with (medical device's type )Promus stent, results are promising, but the study was not designed for clinical endpoint. There is no consensus on IVUS criteria for stent deployment. The MUSIC criteria were widely used in the early 2000, but have limitations for complex long lesions. The AVIO criteria were recently proposed for complex lesions, but these criteria also have some issues and the complexity make their routine use challenging. We performed a pilot study for long complex lesion analysis using IVUS, in order to define easy to use criteria, applicable for complex lesions in drug eluting stents (DES) era. The new criteria (OPERA) are an adaptation of the MUSIC criteria. OTELLO study is an ongoing trial sponsored by Boston Scientific Inc, to determine Major Adverse Cardiac Event with the new TAXUS Element stent. 500 patients will be enrolled in the study. Main question Is IVUS using simplified new criteria beneficial for long (>28mm) TAXUS element stent deployment? Study design This study will consist to prospectively include consecutive patients with>28mm taxus element stent using IVUS. OPERA Criteria for stent deployment will be the objectives to reach. OPERA is an adaptation of the MUSIC criteria for long complex lesion. The patients from the OTELLO study, with the same inclusion criteria, will composed the control group . Population will be matched using the propensity score. 20 to 30 French centers involved in OTELLO study will be contacted for participating in OPERA. Hypothesis: Long lesion percutaneous coronary intervention(PCI) have specific characteristics like Diffuse old atheroma Calcifications Discrepancies between prox and distal diameter Infiltration longer than the target lesion Bifurcations Inhomogeneous strength due to the balloon (Laplace law) Primary hypothesis Long Taxus element deployed using IVUS and OPERA criteria have better outcomes than without IVUS Primary Objectives 38% MACE (SAT, target lesion revascularization (TLR), myocardial infarction (MI), Death) reduction using IVUS and OPERA criteria for Taxus element ≥ 28 mm implantation Secondary endpoint MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria Safety: procedural Stroke, Urgent cardiac surgery, procedural MI Comparison of IVUS criteria: OPERA, MUSIC, AVIO Secondary objectives Safety of OPERA criteria Feasibility of using OPERA criteria in non expert IVUS center MACE determination with a 4% margin error for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria Methods Inclusion of consecutive patients using IVUS Taxus element ≥ 28 mm in a multicentric study propensity score matched analysis matched for comparison to OTELLO study. (Same inclusion criteria as OTELLO) Statistical analysis Primary Endpoint: MACE expected in the OTELLO study=18% MACE expected in the OPERA study=11% Number of patient in the OTELLO study=500 Alpha=0.05,1- Beta=0.73 Number of patients analysable in the OPERA study needed =250 patients i.e 300 pts inclusions. Secondary Endpoint 4% margin error with a MACE of 11% need also 250 pts Type of study Biomedical research French study Centralized IVUS analysis 1, 6 and 12 months telephone contact Safety and efficacy measures Efficacy: MACE (Cardiac Death, target vessel revascularization (TVR), Myocardial Infarction) at 12 months Safety: procedure related event: Urgent surgery, According to Good Clinical Practices serious adverse event (SAE) declared within 24 Hours

The aim of this study is to assess whether the clinical management of patients with recent acute-onset chest pain without acute coronary syndrome may be optimized by a combined coronary CT angiography (CTA) + CT myocardial perfusion (CTP) guided, rapid diagnostic strategy as compared to CTA alone. CT diagnostic evaluation and potential referral for invasive testing will be performed within 2 weeks after hospital discharge. The following main hypothesis will be tested: - Combined assessment of coronary anatomy and myocardial perfusion using 320 MDCT results in a safe and optimized, cost-effective invasive treatment strategy

The proposed Phase I/II clinical trial will be used to determine the safety and toxicity of direct administration of the vector AdVEGF-All6A+ to the ischemic myocardium and to generate preliminary evidence regarding whether direct administration of AdVEGF-All6A+ to the ischemic myocardium will induce growth of collateral blood vessels and improve cardiac function. This is a three-part, multinational/multi-center, placebo controlled study.

To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.

This study is to assess the function of blood vessels while being treated with different types of blood thinners to determine the effect of these medications on blood vessels.