Loading clinical trials...
Loading clinical trials...
Showing 1-18 of 18 trials
NCT06816693
The goal of this mixed prospective observational and qualitative studies is to evaluate the usability of a newly developed application (App) and the feasibility and perception of a 12 weeks tele-cardiac rehabilitation (tele-CR) program. The main question it aims to answer is: Does tele-CR program intervention a acceptance feasibility in coronary heart disease patients? The findings will guide subsequent intervention design studies.
NCT06916520
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight. Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS). Study design: Open-label, single-centre, randomized controlled trial. Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome. Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin. Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.
NCT07444957
This prospective, multicenter, post-market observational study aims to evaluate the safety and effectiveness of the crystalline sirolimus-coated balloon (SeQuent® Sirolimus-Coated Balloon) for the treatment of coronary artery disease in routine clinical practice. Consecutive, unselected adult patients undergoing percutaneous coronary intervention for de novo coronary lesions or in-stent restenosis will be enrolled. The primary objective is to assess target lesion failure at 12 months, defined as the composite of target vessel myocardial infarction or ischemia-driven target lesion revascularization. Secondary objectives include angiographic procedural success, major adverse cardiovascular events, bleeding outcomes, and longer-term clinical results up to 36 months, as well as outcomes across predefined anatomical and clinical subgroups. The study seeks to answer whether treatment with the crystalline sirolimus-coated balloon provides a safe and effective revascularization strategy in a real-world population with diverse clinical presentations and lesion characteristics.
NCT06747234
The development of atherosclerosis is significantly influenced by the interplay between lipid and inflammatory factors. Endotoxemia, defined as the presence of endotoxins, particularly lipopolysaccharides (LPS) derived from Gram-negative bacteria, in the bloodstream, is closely associated with low-grade inflammation. This chronic, systemic inflammatory response does not reach the severity of acute inflammation but can contribute to the development of atherosclerosis and cardiovascular disease (CVD). Lipopolysaccharide-binding protein (LBP) is a soluble acute-phase protein that binds to bacterial LPS. Elevated levels of LBP have been linked to increased low-grade inflammation, which further exacerbates chronic inflammation and metabolic dysregulation. Dietary fiber, such as oat bran, may have a role in mitigating the effects of endotoxemia and its associated inflammation. Furthermore, dietary fiber could play a role in improving plasma lipid profiles. The present study will investigate the effect of oat bran supplementation on cardiometabolic risk markers, LBP concentrations, selected fecal bacteria, and short-chain fatty acids receptors gene expression in peripheral blood mononuclear cells in patients with coronary artery disease.
NCT07225842
The primary aim of this study is to determine rates of patients with optimal platelet reactivity range, defined as PRU levels between 85 and 208, when using a (PFT)-guided titration of cangrelor infusion rate (cangrelor titration) compared to 0.75 mcg/kg/min (standard-dose infusion) for bridging.
NCT07295665
Thrombosis formation is the core mechanism for the occurrence of major adverse cardiovascular and cerebrovascular events in patients with coronary heart disease. Antithrombotic therapy is one of the most important treatment methods for secondary prevention of coronary heart disease. Antithrombotic drugs, while reducing ischemic events, often significantly increase the risk of bleeding. How to balance the risk of recurrent ischemic events and bleeding events in patients with coronary heart disease is a major challenge in the treatment of coronary heart disease. This project establishes a high-quality multicenter, prospective coronary heart disease cohort, with patients covering various clinical characteristics such as different regions, ages, and comorbidities. It verifies the ischemic risk and bleeding risk model developed in Project 1, compares the efficacy improvement of the new model with the traditional risk model, and verifies the effectiveness and stability of the model in different subgroups of the population, and assesses the generalizability of the model in real-world clinical practice, providing high-quality evidence-based basis for the formulation of individualized and precise antithrombotic strategies for coronary heart disease.
NCT07025148
The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the HBR-ARC criteria and HIR defined as ABCD-GENE score ≥10) following PCI. We hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.
NCT06919562
Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic local inflammation which may lead to in-stent restenosis, absence of physiological coronary vasomotion and vessel caging which makes future coronary artery bypass grafting (CABG) impossible. A bioresorbable scaffold (BRS) is designed to overcome these limitations. The first generation BRS was shown to be clinically inferior to DES due to a slightly higher rate of stent thrombosis. To overcome this problem, several scientific developments have been achieved in the past few years, such as thinner BRS strut construction and improved implantation technique by using PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). A PCI protocol that combines implantation of a second generation thin-strut BRS, mandatory PSP implantation method and mandatory intracoronary imaging-guidance has not yet been investigated. The aim of this study is to investigate feasibility of a new PCI protocol with implantation of the second generation Meres100 thin-strut BRS combined with a protocolized PSP implantation technique guided by intracoronary imaging.
NCT07013344
This study aim to investigate the association between plasma NT-proBNP levels and the presence, extent and severity of stenosis in patients with suspected coronary artery disease.
NCT06986889
Randomized controlled trial for comparison of the hand dysfunction in coronary diagnosis and intervention via distal vs conventional radial access
NCT06867926
The objective of this study was to determine the levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG), an indicator of oxidative stress, and to demonstrate oxidative DNA damage in cardiac rehabilitation treatment in patients with coronary artery disease. Additionally, proinflammatory cytokines TNFα, IL-1β, and IL-6 levels were measured to evaluate the significance of cardiac rehabilitation treatment in patients with coronary artery disease and to assess the correlation between cytokine levels and 8-OHdG levels.
NCT06931574
The Crush technique for coronary bifurcation lesions has evolved significantly since its introduction to the literature by Colombo et al. in 2003, with several iterations, including double kissing balloon inflation. The main disadvantage of the historical Crush technique is the low success rate of the final kissing balloon inflation. An improvement came with the introduction of double kissing crush stenting aiming for the shorter protrusion and kissing balloon dilation performed before and after main branch stent implantation. The double kissing crush provides a significant reduction in major adverse cardiovascular events compared to Provisional stenting, Crush, and Culotte techniques. Recently, a novel modified mini-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired, and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon), and this causes less disruption of the stent cells. To date, no data compares the mid-term outcomes of double kissing crush and controlled balloon-crush stenting techniques in patients with complex coronary bifurcation lesions. Hence, this study aimed to determine the clinical results of double kissing crush and controlled balloon-crush techniques under mid-term follow-up.
NCT06919237
Coronary artery disease (CAD) is associated with autonomic dysfunction and is characterized by reduced heart rate variability (HRV) and impaired heart rate recovery. Regular exercise improves cardiovascular outcomes in CAD, with high-intensity interval training (HIIT) showing superior benefits compared to moderate-intensity continuous training (MICT). However, the full potential of exercise is not used in the clinical context since some of the training principles are neglected, contributing to a high number of exercise non-responders. HRV-guided training has been identified as an alternative prescription technique for cardiovascular endurance exercise and has contributed to greater improvements compared to standard prescriptions. Thus, this study aims to assess the chronic effects of exercise on cardiovagal modulation, baroreflex sensitivity, arterial stiffness, and cardiorespiratory fitness in patients with CAD, specifically determining whether heart rate variability-guided training yields different outcomes compared to a traditional prescription in a 12-week exercise intervention. A total of 48 participants, will be recruited and randomized into one of 3 groups: high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), and HRV-guided training. The intervention will consist of 12 weeks of supervised exercise, with 3 weekly sessions. Participants in the HRV-guided training group will have their exercise intensity adjusted based on their individual HRV profiles. Moderate- or high-intensity sessions are prescribed when the 7-day rolling average of LnRMSSD remains within the smallest worthwhile change (SWC). If it falls outside the SWC, low-intensity sessions or rest are recommended. In the HIIT group, sessions will consist of 4 bouts of 2 minutes at 80-90% HRR during the first 4 weeks, increasing to 6 bouts of 2 minutes at the same intensity in weeks 5-8, and progressing to 6 bouts of 2 minutes at 90% HRR in the final 4 weeks. In the MICT group, participants will perform continuous sessions starting with 2x10 minutes at 50-60% HRR in the first 4 weeks, progressing to 2x12 minutes at the same intensity in weeks 5-8, and increasing to 2x15 minutes at 60-70% HRR in the final phase. Cardiovagal modulation, cardiorespiratory fitness, BRS, and AS will be assessed at the baseline and after the 12 weeks of intervention. Most cardiac rehabilitation programs use the "one-size-fits-all" approach, which is a limitation of the literature, leading to a large number of exercise nonresponders to changes in cardiorespiratory fitness. HRV-guided training seems to be a more individualized method of aerobic prescription and may lead to greater improvements in cardiorespiratory fitness and in cardiovagal modulation. This study will contribute to generate evidence regarding aerobic exercise prescription in cardiac rehabilitation.
NCT06775028
The study will verify if a structured multidisciplinary approach (called iABC), aimed to improve the appropriate management of elderly AF patients with multimorbidity (the i-ABC group), would provide a clear evidence of an improvement in clinical conditions and quality of life compared to usual clinical care. The i-ABC group in AFFIRMO will follow the ABC pathway, focused on three domains: avoid stroke with anticoagulation (with optimized VKA or label-adherent DOAC use); better symptom management; and optimized management of associated cardiovascular and non cardiovascular comorbidities. The study will be conducted in Bulgaria, Denmark, Italy, Romania, Serbia and Spain .
NCT06684366
Evaluate Adherence to the 2019 ESC Guidelines and standard care protocols for managing patients with the chronic coronary syndrome within the center
NCT06681155
This study is a multicenter prospective observational clinical study, which will be conducted in 11 hospitals, and approximately 500 subjects will be enrolled. Plaque morphology and stability of non-culprit lesions were assessed by intravascular ultrasound (IVUS) and optical coherence tomography-near-infrared spectroscopy (OCT) after percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Plaques were grouped according to high-risk or non-high-risk. Clinical follow-up was conducted after PCI.
NCT06669793
Percutaneous coronary intervention (PCI) is one of the standard treatments for patients with acute and chronic coronary syndromes that are consistently recommended by current national and international guidelines. Currently, even with the most advanced design concepts of drug-eluting stents (DES), the permanent foreign body and in-stent restenosis after implantation are still very detrimental to the clinical outcomes of patients. These problems have been mitigated to some extent by the advent of the drug-coated balloon (DCB), a special balloon coated with an antiproliferative drug that is uniformly delivered to the vessel wall during endovascular dilatation to inhibit endothelial proliferation. This study is a prospective randomized study of a novel drug-coated balloon for the treatment of de novo coronary artery large vessel lesions. By comparing the clinical outcomes of the novel BA9 drug-coated balloon (BCB) with those of the paclitaxel-coated balloon (PCB) in the treatment of de novo coronary artery large vessel, we evaluated the safety and efficacy of the BCB for such lesions, and provided evidence for the later use of rapamycin-based drug-coated balloons in PCI. They are randomly dividing them into BCB treatment group and PCB treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation.
NCT06602583
1. The patients suspected coronary artery disease or those needing an angiography as per the inclusion criteria would be included after a 2d echocardiography and treadmill test/ stress myocardial stress imaging (if indicated) after a written and informed consent. 2. Anthropometric and lab paraments would be recorded. 3. Study will have 2 arms. I. A study arm 1 - baseline comparative arm of patients having undergone angiography with standard dose/ old low dose angiography. II. A study arm 2 - a comparative arm where the patients being once eligible for the study; would undergo angiography using the new low dose protocol. 4. Post completion of the sample size the data of each angiographic view would be noted in both the study arms