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Heart Diseases clinical trials

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NCT ID: NCT04172974 Recruiting - Depression, Anxiety Clinical Trials

eHealth Intervention to Manage Depression and Anxiety in Patients With Ischemic Heart Disease

eMYHeart
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness and cost-effectiveness of a therapy-assisted internet-based intervention in patients with ischemic heart disease and co-morbid depression and anxiety referred for cardiac rehabilitation. Half of the patients will receive the intervention and the other half usual care. We hypothesize that the intervention will lead to a reduction in patients' symptoms of depression and anxiety and be cost-effective.

NCT ID: NCT04162171 Recruiting - Clinical trials for Myocardial Infarction

Cohort Study - SBRT for VT Radioablation

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. Current treatment for VT consists of either implantable defibrillators (ICDs), suppressive drug therapy, catheter ablation or a combination of all 3. Implantable Defibrillators (ICDs) reduce sudden death and can terminate some ventricular tachycardia (VT) without shocks, but they don't prevent VT. The occurrence of ≥1 ICD shock is associated with reductions in mental well-being and physical functioning, and increases in anxiety and sometimes depression. Further, ICD shocks have been consistently associated with adverse outcomes, including heart failure and death. Furthermore, the most important predictor of ICD shocks is a history of prior ICD shocks. Therapies to suppress VT include antiarrhythmic drug therapy and catheter ablation, neither however is universally effective. When VT recurs despite antiarrhythmic drug therapy and catheter ablation, novel yet invasive, approaches may be required. Such invasive procedures carry consequent risks of cardiac and extra-cardiac injury. Stereotactic body radiotherapy (SBRT) is a non-invasive technique that delivers high doses of radiation precisely to specified regions in the body, while minimizing exposure to adjacent tissue. This technique is currently, and commonly used in the treatment of cancer. Conventional application of SBRT has made use of its ability to spare non-target tissue, including for treatment of tumors near the heart. More recently, clinicians have changed the paradigm, by focusing radioablative energy on ventricular scar responsible for ventricular tachycardia. Pre-clinical studies have supported the concept and were followed by first-in-human VT therapeutic experience in 2017. Subsequent studies have had encouraging results for patients who failed or were unable to tolerate conventional treatment.

NCT ID: NCT04152967 Recruiting - Clinical trials for Congenital Heart Disease

New Designed ePTFE Valved Conduits for Surgical Reconstruction of Right-ventricular Outflow Tract

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Valved conduits used for the reconstruction of right-ventricular outflow tract are applied in the surgical repair of complex congenital heart disease(CHD) such as pulmonary atresia(PA), truncus arteriosus, severe tetralogy of Fallot(TOF) for their significant roles in reducing pulmonary valve regurgitation and preserving right ventricle function. With a rising cases of complex CHD and patients with pulmonary valve regurgitation in TOF repair, a further demand is underway for valved conduits. Meanwhile, common biological valved conduits applied in foreign countries are not approved in China yet, with high failure and reintervention, reducing the long-term survival. Our team manufactured a novel valved conduit with 0.1mm expanded polytetrafluoroethylene and gore-tex conduit. This ePTFE valved conduit played a satisfying role in anti-regurgitation and failure rate through in vitro fluid test and animal experiments. Besides, our team manufactured templates for the conduit and also simplified the suturing process so that the repeatability of suturing valved had been risen. Until now, over 70 cases have been implanted with this ePTFE valved conduit with positive early and mid-term follow-up results. Despite the progress which have been made, there still remain some problems to solve. First, systematic prospective randomized comparative study will be performed. Second, this is just a single-center study. Third, these patients should have longer follow-up time to evaluate the ePTFE conduit long-term effect. Finally, imaging data are blank for evaluating the function of the conduit and right ventricle. In this prospective comparative research, the new designed ePTFE valved conduit and bovine jugular vein valved conduits are conducted as a randomized controlled trail. Cardiac magnetic resonance imaging is used to precisely evaluate the anti-regurgitation effect of the valved conduit and the right ventricle function. Investigators can further access the application of this newly designed ePTFE valved conduit. Investigators aim to provide a self-manufactured, low failure rate valved conduit.

NCT ID: NCT04151680 Recruiting - Atrial Fibrillation Clinical Trials

Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients

INTERMITTENT
Start date: December 1, 2019
Phase:
Study type: Observational [Patient Registry]

Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation. Uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists. The investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (HBR) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.

NCT ID: NCT04142021 Recruiting - Clinical trials for Coronary Artery Disease

Safety and Feasibility Evaluation of Planning and Execution of Surgical Revascularization Solely Based on Coronary CTA and FFRCT in Patients With Complex Coronary Artery Disease (FASTTRACK CABG)

Start date: September 1, 2020
Phase:
Study type: Observational

To assess the feasibility of coronary computed tomography angiography (CTA) and fractional flow reserve derived from CTA (FFRCT) to replace invasive coronary angiography (ICA) as a surgical guidance method for planning and execution of coronary artery bypass graft (CABG) in patients with 3-vessel disease with or without left main disease. The FASTTRACK CABG study is an investigator-initiated single-arm, multicentre, prospective, proof-of-concept, and first-in-man study with feasibility and safety analysis. Surgical revascularization strategy and treatment planning will be solely based on coronary CTA and FFRCT without knowledge of the anatomy defined otherwise by ICA that will be viewed and analyzed only by the conventional heart team. Clinical follow-up visit including coronary CTA will be performed 30 days after CABG in order to assess graft patency and adequacy of the revascularization with respect to the surgical planning based on non-invasive imaging with functional assessment and compared to ICA. Primary feasibility endpoint is CABG planning and execution solely based on coronary CTA in 114 patients. Primary safety endpoint based on 30-day coronary CTA is graft assessment either at the ostium, in the shaft or at the anastomoses of each individual graft either single or sequential. The FASTTRACK CABG study is the first study to assess safety and feasibility of planning and execution of surgical revascularization in patients with complex coronary artery disease, solely based on coronary CTA combined with FFRCT.

NCT ID: NCT04138966 Recruiting - Anesthesia Clinical Trials

Comparing Skin Conductance and Nol-index

Start date: October 20, 2019
Phase:
Study type: Observational

Comparison of twà different nociception monitors during general anesthesia

NCT ID: NCT04131075 Recruiting - Depression Clinical Trials

The Cerebral-Coronary Connection (C3) Study

C3
Start date: March 1, 2017
Phase:
Study type: Observational

This is a prospective cohort blinded study with the aim to investigate the prevalence and clinical impact of coronary microcirculatory dysfunction (CMD) in patients with ischemic heart disease, and its association with cerebral small vessel disease (CSVD) and depressive disorders. In addition, CMD and CSVD linkage to systemic inflammation and endothelial function will also be investigated.

NCT ID: NCT04127474 Recruiting - Clinical trials for Coronary Heart Disease

Expression of Trefoil Factors and Adrenomedullin in Subjects With Chronic Periodontitis and Coronary Heart Disease

Start date: October 14, 2019
Phase:
Study type: Observational

To assess the demographic variables, periodontal parameters and to determine the expression of Trefoil factors 2 and 3 and Adrenomedullin in unstimulated saliva samples of periodontally healthy subjects with coronary heart disease and generalised chronic periodontitis subjects with and without coronary heart disease.

NCT ID: NCT04126018 Recruiting - Aortic Stenosis Clinical Trials

Comparative Imaging Assessment of Valvular Heart Disease

Start date: August 23, 2019
Phase:
Study type: Observational

The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.

NCT ID: NCT04124120 Recruiting - Clinical trials for Coronary Artery Disease

Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

ROMA:Women
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grfating (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grfating (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.