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Showing 1-20 of 158 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.
NCT07468955
Objective: This study aimed to retrospectively evaluate the impact of cardiac rehabilitation (CR) on functional capacity, depressive symptoms, and the quality of life and sleep in patients with heart disease. Methods: A retrospective analysis was conducted on patients who participated in a structured CR program. Clinical records were reviewed to compare pre- and post-rehabilitation outcomes. Functional capacity was assessed using the 6-Minute Walk Test (6MWT), while depressive symptoms, health-related quality of life, and sleep quality were evaluated using the Beck Depression Inventory (BDI), the Short Form-36 (SF-36), and the Pittsburgh Sleep Quality Index (PSQI), respectively.
NCT07451873
The primary research objective of the project is to determine the role of eGC in microvascular reactivity in patients with coronary heart disease (CHD) before and after bypass grafting (cross-sectional study 2).The main objective of the project is to increase the excellence and interdisciplinarity of scientific work at MEFOS by connecting researchers from different scientific fields, improving conditions and resources for scientific work, and increasing international cooperation, in line with strategic objective 1: raising scientific excellence. The results of the project could provide pathophysiological insight into the development and maintenance of endothelial dysfunction in CVD, as well as identify new biomarkers for CVD.
NCT05133921
Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon. Treating in-stent restenosis (ISR) with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology (ESC) guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES. Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion. Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis\<30% post-DCB, maintaining TIMI flow=3, DCB dilation time\<60s, and appropriate balloon to vessel ratio\> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice. This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.
NCT07373119
The goal of this clinical trial is to improve the frailty in old patients who have a cardiac disease . Researchers will determine the improvement in the instability and the strength along twelve sessions based on guided exercises and mobility techniques made by physiotherapists. Research team will also evaluate the medications and diet, as well as laboratory and clinical tests.
NCT07346664
Patients with coronary heart disease (CHD) require long-term medication and lifestyle modification following percutaneous coronary intervention (PCI). However, they often face challenges such as poor medication adherence and inadequate self-management. This study aims to evaluate the effects of the transitional care model (TCM) on CHD patients after PCI, regarding medication adherence, self-efficacy, and lipid levels.
NCT04300764
Low mobility is a mediator for poor outcomes of hospital care. Wearable devices will be used and 2-way texting via patient smartphones to monitor patients' physical activity during hospitalization with and without gamification to improve patient adherence to existing guidance on recommended activity. After discharge, investigators will assess patient care utilization (SNF, inpatient vs home rehab, ED visits, readmission) and conduct validated surveys on patient function at 30 days after discharge.
NCT04682769
Depression doubles the risk of death in patients with coronary heart disease (CHD), but so far, there is insufficient evidence that we can reduce the risk of death by treating depression. This study will investigate the cardiac risk markers that are associated with depression symptoms that remain despite treatment, and identify potential targets for their treatment. The results of the study will inform the development of more effective interventions to improve both depression and survival in patients with CHD.
NCT06615284
A Phase 1 study will assess the safety, tolerability, and pharmacokinetics of Atorvo+™ in healthy adult participants. .
NCT07230847
BioFreedom™ is the world's first polymer-free drug-coated stent (DCS), utilizing a proprietary microstructured surface technology. Its abluminal microporous surface directly carries BA9™ (a sirolimus derivative) with high lipophilicity. This design mitigates inflammatory responses while promoting early vascular healing and reducing thrombotic risk. Extensive clinical evidence has validated BioFreedom™'s superior performance in high-bleeding-risk (HBR) populations. However, comprehensive assessments of neointimal coverage and quantitative neointimal transformation post-implantation remain insufficient. With advancements in ultra-high-resolution optical coherence tomography (OCT), detailed evaluation of coronary stent healing has become feasible. This study will employ OCT to comparatively assess vascular healing patterns-including neointimal transformation and strut coverage-in ACS patients with HBR receiving either the commercially available BioFreedom™ DCS or Xience drug-eluting stent system. The findings will provide multidimensional insights into the devices' post-implantation efficacy and safety profiles.
NCT07186582
The Verona Coronary Physiology Interventional Registry (VR-CP) is an observational study that collects information on patients with suspected coronary artery disease who underwent coronary angiography with a functional assessment of coronary stenoses. These functional tests include fractional flow reserve (FFR) or angiography-derived FFR, which help physicians understand whether a narrowing in the coronary arteries is likely to reduce blood flow to the heart. The main goal of the study is to investigate whether the functional severity of coronary lesions is associated with future cardiovascular events, such as heart attack, the need for repeat procedures, or cardiovascular death. Additional objectives are to compare invasive FFR with angiography-derived FFR, to evaluate how these values relate to angina symptoms, and to analyze differences between patients treated conservatively with medications and those treated with coronary interventions. The study is retrospective and single-center, including approximately 1,000 patients who underwent coronary physiology testing between 2010 and 2024 at the University Hospital of Verona. Follow-up information is obtained through review of medical records, outpatient visits, or telephone contacts, and patients will be followed for up to 10 years. By combining detailed coronary physiology data with long-term clinical outcomes, this registry aims to improve understanding of which patients are at higher risk and to guide future strategies for the diagnosis and treatment of coronary artery disease.
NCT06216847
Coronary heart disease (CHD) stands as a foremost contributor to global mortality, characterized by complex pathogenesis that renders conventional "one-size-fits-all" preventive strategies inefficient. Therefore, the investigators designed a prospective, multi-center cohort study among patients hospitalized due to either confirmed or suspected CHD, which aimed to establish a holographic data set for the diagnosis and treatment of CHD and explore the impact of critical therapeutic strategies in the real world on the clinical outcomes of CHD patients, providing evidence to optimize the management pathway.
NCT07149688
This is a prospective observational cohort study conducted in Qujiang District, Zhejiang Province, China, aiming to evaluate the effectiveness of a comprehensive management program for elderly patients with chronic cardiovascular diseases (CVDs). The program integrates pharmacological treatment, lifestyle modification, health education, and long-term follow-up, with enhanced monitoring using 7-day ECG recording. The study focuses on major chronic CVDs including hypertension, coronary artery disease, atrial fibrillation, and heart failure. Approximately 30,000 participants aged ≥60 years will be enrolled and followed for up to 10 years.
NCT07062432
This study evaluates the effectiveness of a continuous comprehensive nursing (CCN) system compared to routine care for patients after coronary artery bypass graft (CABG) surgery. The primary goal is to determine if the CCN system improves postoperative hemoglobin levels. The study also investigates the effects on quality of life, mental health (anxiety and depression), red blood cell indices, immune markers, and patient satisfaction.
NCT06335901
This study evaluated and compared the prognostic value of different Baseline data and clinical variables to develop predictive model in patients with CHD.
NCT04999358
Sarcopenia is a skeletal muscle disease, characterised by low muscle strength and muscle mass, and associated with higher medical care costs, shorter life expectancy and physical dependence. Sarcopenia affects around 1 in 10 older adults in the general population. However, in patients with coronary heart disease (CHD), this number is almost 3 in 10. Patients who have CHD are offered cardiac rehabilitation (CR); a multicomponent programme designed to improve long-term health outcomes. Nutritional education is an important part of CR and typically focuses around modifying fat and carbohydrate intake to lower cholesterol levels and achieve a healthy weight. Currently there is little focus on increasing protein intake, which might reduce the risk of sarcopenia. Eligible patients with CHD and low protein intake will receive the standard nutritional education delivered during CR. Next, participants will be randomised to one of two groups: protein education (intervention), or standard information (control). Whilst COVID-19 restrictions are in place, education will be delivered remotely via pre-recorded video. Outcome measures, including protein intake, sit to stand performance, sarcopenia risk score (modified SARC-F), Physical Activity Vital Signs (PAVS) and waist circumference, will be assessed at baseline, at the end of the standard CR programme and after a follow-up period of the same duration as the CR programme.
NCT06759805
In Norway, more than 11,000 patients undergo percutaneous coronary intervention (PCI) annually. However, a very recent study utilizing registry data show a national average of cardiac rehabilitation (CR) participation of only 14%, despite its proven beneficial effects on readmissions, physical capacity, psychological distress, self-management, and quality of life. CR is strongly recommended in European guidelines. However, uptake is low and is not systematically identifying those in most need of CR. The primary objective of eCardiacRehab is to meet rehabilitation needs of large patient populations regardless of their access to traditional place-based rehabilitation by developing and evaluating the efficacy and cost effectiveness of an interdisciplinary and comprehensive home-based eCardiacRehab programme. eCardiacRehab address patient- and system level challenges in order to increase access to CR. The investigators give particular attention to older patients, women, and those with comorbidities or mental health challenges. Aspects related to continuity of care between specialist and primary care services, health literacy, adherence to treatment, cost effectiveness and ethics are investigated. The investigators will 1) continue to develop the programme with patients, general practitioners, healthcare experts from both specialist and primary care services, and technology developers, 2) develop treatment modules, 3) establish information and communication infrastructure, 4) evaluate the process and efficacy of treatment modules, 5) ensure knowledge development and transfer of competence to the municipalities, and 6) contribute to fulfil the innovation potential for health service and industry partners. eCardiacRehab has the potential to improve interaction and collaboration between primary and secondary care, modernise and digitalise work processes, and develop more coherent and tailored patient pathways. The vision of the home-based eCardiacRehab is to make CR available to all.
NCT04610892
A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.
NCT05834673
The goal of this study is to understand and compare an alternative model of care in comparison to the usual model of care in include male and female participants ≥18 years of age with a history of ASCVD (hear and blood vessels diseases) or high-risk participants who have elevated bad cholesterol (LDL-C ≥1.8 mmol/L). The alternative model of care includes telephone support calls from a study nurse (after visits 1,2 and 4) and text messages to your mobile phone with healthy heart information. The main question it aims to answer is to understand and compare an alternative model of care in comparison to the usual model of care by evaluating the study participants bad cholesterol values after 180 and 365 days of the study. Each participant will take their medications as per usual care but may have the addition of Inclisiran, 284 mg 1.5 ml liquid in a single-use prefilled syringe for under skin administration. In accordance with the current medical practice guidelines for treating heart related conditions, Inclisiran and its product information will be made available for use in both care models. All the participants who decide to take part in this study will be requested to do the following: * Answer any questions from the study doctor or the study staff as accurately as possible when asked about changes in health status, medications, heart health, visits to other doctors or hospital admissions, planned surgery, even if they think none of these are related to the study. * Study doctor will be able to inform them of which medications you can and cannot take as part of this study. * To use mobile phone to receive text messages and/or questionnaires as proposed in the new model of care. * Advise the study doctor if they plan to move away from the geographical area where the study is being conducted during the study period. * Take the medications for cholesterol lowering treatment (such as a statin and/or ezetimibe) that are prescribed by the study doctor. * Tell the study doctor or study staff as soon as possible about suspected participant / participant partner pregnancy. * Tell the study doctor or study staff if they change their mind about taking part in the study. * Attend all the visits (screening visit, visits 1, 2, 3, 4 and visit 5). * Provide all the information that will enable the study team to contact them, i.e., inform the study staff if contact details change, provide contact details of a family member, etc.
NCT06588231
The benefits of cardiac rehabilitation have been supported by a large amount of evidence-based medicine. Cardiac rehabilitation can correct cardiovascular risk factors, reduce morbidity and mortality, and improve quality of life.