Clinical Research Directory

Sustainable Anesthesia in Myocardial Revascularization Surgery.

* Introduction: Greenhouse gases threaten the health and safety of humanity. The Declaration of Helsinki seeks to protect human health and emphasizes the urgency of implementing sustainable strategies. Sustainability is defined by three pillars: economic (costs), social (clinical effectiveness), and environmental (environmental impact). Clinical effectiveness in cardiac surgery has a new paradigm: "optimized recovery," which translates into fewer complications, earlier extubation, shorter ICU stays, and potential cost reductions. The objective of this study is to compare the sustainability of the optimized recovery anesthetic technique with standard anesthetic practice in coronary artery bypass graft surgery, using a non-randomized interventional study design. * Methods: Patients aged 18 years or older with coronary artery disease scheduled for elective coronary artery bypass graft surgery will be recruited. Combined procedures and reinterventions will be excluded. Sample size: The optimized recovery group is expected to reduce postoperative mechanical ventilation by two hours. With a 95% confidence interval, 80% power, and a 1:3 ratio between the groups, a sample size of 29 and 87 patients was estimated for the optimized recovery and standard anesthesia groups, respectively. * The optimized recovery technique includes, preoperatively, oral pregabalin 75 mg, fasting, no benzodiazepines, total intravenous anesthesia, low-dose intravenous fentanyl, methadone 0.1-0.2 mg/kg IV, erector spinae plane block with 0.25% bupivacaine (20 mL per side), and postoperative nausea and vomiting prophylaxis with dexamethasone. Postoperatively, administer paracetamol 1 g IV every 6 hours, NSAIDs, and methadone 1 mg IV as needed. The standard anesthetic technique involves the anesthesiologist administering anesthesia as they have routinely done prior to the study, without changes. * Four anesthesiologists will participate in the study. Only one anesthesiologist will perform the OR technique, and their results will be compared with those of the other three, who will use their standard anesthetic technique. Patient assignment is independent, based on the hospital's schedule. * Analysis: The clinical effectiveness of each technique will be evaluated based on ICU extubation time. An economic analysis will be conducted based on average costs, and critical environmental impacts will be estimated through a life-cycle assessment. * Outcome: The performance of the indicator "Costs in Euros/CO2e/Extubation Time" will be studied. These will contribute to the estimation of an anesthetic strategy that addresses the challenges of sustainable medicine, reduces emissions, and enables the rational use of resources and their associated costs, offering environmentally friendly and clinically effective health solutions.

A Single-centre Study Comparing a Non-invasive Lactate Sensor to Standard Invasive Measurements in Patients Undergoing Coronary Artery Bypass Surgery.

The main goal of this study is to see how well a non-invasive lactate sensor measures lactate levels compared to standard blood tests. This might reduce the need for frequent blood draws during surgery recovery, and also provide a more comfortable experience for patients. This will also give us information regarding the suitability of the lactate sensor for monitoring other patients - for instance people attending the accident and emergency department with chest pain in which lactate levels may help make a quick diagnosis. Patients will be approached for this study if they are undergoing routine coronary artery bypass surgery (CABG) or valve replacement surgery. Participants will wear the non-invasive lactate sensor for up to 14 hours, and the readings will be correlated to lactate levels in blood samples. Once the sensor has been removed and the participant has been discharged from their elective surgery admission, the participant has completed the study. Participation in this study and the data collected from the sensor will help us understand how well it works and how it can be used to improve patient care in the future. In the future, the data from this new device will be used to train computer algorithms to provide quick responses that could help manage a patients condition, improving future medical care.

Oropharyngeal Humidification After Extubation on Thirst

In patients who have undergone endotracheal intubation following cardiac surgery, symptoms such as thirst, dysphagia (difficulty swallowing), restlessness, nausea, and vomiting are frequently observed, and these conditions negatively affect the patients' overall comfort. Especially in the post-intubation period, dryness in the mouth and throat, an intense feeling of thirst, and difficulty swallowing can lead to feelings of suffocation, helplessness, fear, and anxiety in patients. Effective management of these symptoms is critically important both for accelerating the recovery process and for increasing patient satisfaction. Traditionally, methods such as moistening the mouth with a cotton swab have been used to relieve complaints like thirst and dry mouth. However, these practices are often insufficient and have limited effectiveness in increasing patients' comfort. In recent years, the use of oropharyngeal sprays has emerged as an innovative and effective approach to alleviate symptoms such as thirst and dry mouth. In a randomized controlled trial conduct, it was shown that a spray-based oropharyngeal moisturizing program significantly reduced the severity of thirst and discomfort in patients who underwent intubation after cardiac surgery. Thirst and discomfort scores were found to be significantly lower in the spray-applied groups compared to the control group, and no significant difference was observed between the groups in terms of dysphagia frequency or adverse events. Similarly, studies conducted in different surgical and intensive care populations have shown that applications of cold water or cold saline sprays significantly reduce complaints of thirst and dry mouth, increase patient comfort, and are safe to use. Additionally, it has been reported that alternative approaches such as menthol lozenges or aromatherapy also have positive effects on thirst, nausea, and comfort after cardiac surgery. Examining the effects of oropharyngeal sprays and similar practices on parameters such as thirst, dysphagia, discomfort, nausea, vomiting, and overall comfort in patients who are intubated after cardiac surgery may contribute to the development of innovative and effective approaches in patient care. Integrating such practices into postoperative care protocols carries significant potential for increasing patient comfort and supporting the recovery process. This randomized controlled study aims to investigate the effects of oropharyngeal humidification after extubation on thirst, pain, and anxiety in patients undergoing coronary artery bypass surgery.

GLS in Difficult CPB Weaning

The goal of this observational study is to learn whether global longitudinal strain (GLS), measured by echocardiography, can predict difficulty separating from cardiopulmonary bypass (CPB) in adults undergoing elective cardiac surgery. The main questions it aims to answer are: * Can preoperative GLS measurement predict difficult separation from CPB? * Are GLS values associated with outcomes such as intensive care unit (ICU) stay, hospital stay, cardiac biomarkers, or 30-day mortality? Participants will: * Undergo standard cardiac surgery requiring CPB * Have echocardiographic assessments (TTE before and after surgery) * Have their recovery and outcomes monitored, including ICU and hospital stay, postoperative labs, and survival within 30 days

A Single Centre Study Comparing Continuous Interstitial Fluid Lactate Detection to Standard Measurements of Lactate in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery and/or Valve Replacement.

The main goal of this study is to see if a wearable device can reliably track changes in lactate levels in the body. We\'ll compare the device\'s readings to standard blood tests to ensure accuracy. If successful, this device could reduce the need for frequent blood tests during surgery recovery, making patients more comfortable. It might also be useful in emergency rooms for quick diagnoses, especially for patients with chest pain. This study will take place at Barts Hospital with patients having planned coronary artery bypass graft (CABG) and/or replacement valve surgery. Participants will wear the sensors on their upper arm, during which the sensors will continuously measure lactate levels. Participants will also have hourly blood samples taken. In the future, the data from this new device will be used to train computer algorithms to provide quick responses that help manage a patient\'s condition, improving future medical care and technology.

Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery

This interventional prospective randomized study is designed to compare hemodynamic management using postural mobilization (+/- noradrenaline) versus noradrenaline only in patients undergoing open-heart coronary artery bypass graft (CABG) surgery.

Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence

The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. Several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. These tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training.

Improving Cardiac Rehabilitation Exercise Using Target Heart Rate Trial

The goal of this clinical trial is to compare two types of exercise prescriptions in cardiac rehabilitation eligible older adults (60 years or older) with heart disease. The investigators found in a single site pilot trial (insert NCTxxx) that one exercise prescription was better and are now repeating this study in a larger population at two sites (Baystate Medical Center, Springfield MA and Henry Ford Health System, Detroit MI). The main questions the investigators aim to answer are: 1. Compare two different exercise prescriptions in cardiac rehabilitation on exercise outcomes 1. Graded exercise test +Target heart rate range prescription \[GXT-THRR\] 2. Rating of perceived exertion (RPE) 2. What is the role of psychological feedback on fitness outcomes during cardiac rehabilitation and physical activity outside of cardiac rehabilitation. 3. What are the long-term clinical outcomes between the two exercise prescriptions Participants will be asked to: * Complete surveys about physical activity, exercise anxiety, exercise efficacy, and fears about exercising * Perform fitness measures (6-minute walk test, balance tests, stand to sit tests, a 400 meter walk, and handgrip strength) * Attend at least 18 sessions of cardiac rehabilitation after they are randomized to their exercise prescription group * Wear a heart rate monitor and a physical activity monitor per study protocol Participants will be randomized (flip of a coin) to either receive a graded exercise test and psychoeducational feedback or lifestyle education (nutrition for cardiac). The graded exercise test will be used to create a personalized exercise prescription with the target heart rate range calculated from the test and the lifestyle education group will use their ratings of perceived exertion for their exercise prescription.

CABGpreHAB - a Feasibility Study Protocol

Patients with ischemic heart disease (IHD) awaiting coronary artery bypass graft (CABG) surgery often face challenges like advanced age, frailty, comorbidities, and physical inactivity. These factors, combined with the physiological and psychological stress of surgery, can hinder postoperative recovery. Traditionally, strategies to improve surgical outcomes focus on the intra- and postoperative periods. However, the pre-surgery waiting period offers a "window of opportunity" for prehabilitation, which aims to enhance patients' functional capacity through exercise, nutrition, and psychological support. The CABGpreHAB feasibility study evaluates the feasibility of a home-based multimodal prehabilitation intervention for patients awaiting elective CABG surgery. This randomized pilot study compares the intervention plus usual care to usual care alone, assessing feasibility outcomes like recruitment, retention, attrition, fidelity, and adherence. The study aims to optimize a subsequent full-scale randomized controlled trial (RCT) and improve patient outcomes by leveraging the pre-surgery period for prehabilitation.

Remote Ischemic Preconditioning in Type 2 Diabetic Patients Undergoing CABG

This randomized, double-blind, prospective clinical trial aims to investigate the effect of remote ischemic preconditioning (RIPC) on myocardial protection in patients with type 2 diabetes mellitus undergoing elective coronary artery bypass graft (CABG) surgery. Perioperative myocardial injury remains a significant concern during CABG, particularly in high-risk patients such as those with diabetes. RIPC is a low-cost, non-invasive intervention that may reduce myocardial damage by enhancing ischemic tolerance through intermittent limb ischemia. Sixty patients aged 40-85 years with type 2 diabetes scheduled for isolated CABG will be randomized to either receive RIPC or standard care. RIPC will be applied through five cycles of upper limb cuff inflation and deflation prior to sternotomy. High-sensitivity troponin T levels will be measured at 24, 48, and 72 hours postoperatively to assess myocardial injury. Secondary outcomes include acute kidney injury (KDIGO classification), maximum vasoactive-inotropic score (VIS) during the first 72 postoperative hours, ICU and hospital length of stay. This study will provide insight into the cardioprotective role of RIPC in diabetic patients undergoing cardiac surgery.

Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease

The objective of this study is to evaluate the safety and feasibility of Minimally Invasive Coronary Artery Bypass surgery in selected patients ,with multi vessel coronary disease. This trial is designed to be a pilot study that will gather comparative information on the clinical performance of the minimally invasive treatment, evaluated by the composite measure of all-cause death, myocardial infarction, stroke, or unplanned repeat revascularization - in hospital, 30-day and 6 months.

Prospective Cohort Study on Fuzheng Yangxin Prescription For Rapid Rehabilitation of Patients With Qi-Yin Deficiency Syndrome After Coronary Artery Bypass Grafting

Data from the Global Burden of Disease Study 2021, recently published in the Lancet, show that ischaemic heart disease remains the first most common cause of death worldwide. Ischemic heart disease mainly refers to coronary artery stenosis or obstruction caused by coronary artery atherosclerosis leading to myocardial ischemia heart disease, called coronary heart disease. "China Cardiovascular Health and Disease Report 2022" mentioned that coronary heart disease is an important cardiovascular disease affecting the health of Chinese residents, and its prevalence and mortality are on the rise. Coronary artery bypass grafting (CABG) and interventional therapy (PCI) are commonly used in the treatment of coronary heart disease. CABG surgery can significantly reduce the recurrence of angina pectoris, the incidence of acute myocardial infarction and improve the survival rate of patients, the patency rate of 5 years after mammary arterial bridge can reach more than 90%. Current guidelines and various RCT studies have shown that CABG is the gold standard for revascularization in patients with complex coronary artery disease. With the increasing aging of Chinese population, there are more and more cases of complex coronary artery diseases, and CABG, as the first choice for complex coronary artery diseases, will be more and more widely used in the foreseeable future. At present, the number of coronary artery bypass surgery is on the rise, about 50,000 cases per year. Traditional Chinese medicine can play a role in preventing complications, improving the quality of life and long-term curative effect of patients after CABG. It is particularly important to actively seek the treatment of integrated Chinese and Western medicine for patients after CABG. This study aims to explore the effectiveness and safety of Fuzheng Yangxin prescription in the treatment of Qi-Yin deficiency after CABG by means of a prospective cohort study, so as to determine the efficacy of Fuzheng Yangxin prescription on the recovery after CABG. To formulate a routine program of Chinese and Western combined therapy for postoperative rehabilitation of cardiac surgery, and actively promote the technology and program, promote the transformation of intellectual property rights, etc., and contribute to the formulation of relevant guidelines.

Graft Failure and Consequences of Coronary Artery Bypass Graft Surgery

Coronary artery bypass graft (CABG) surgery is the commonest type of heart operation performed. During this, arteries or veins (termed 'grafts') are used to supply blood around blockages within the blood vessels that supply the heart. Unfortunately, these grafts can sometimes fail, and patients can also experience complications like heart attacks and strokes, after surgery. It is known that vein grafts are more likely to narrow over time. Additionally, treating vein graft failure is very challenging, as repeat surgery is riskier and procedures to stent open the veins can also fail. However, it is not fully understood why these complications occur. In this study, the investigators will use an imaging technique called a total-body Positron Emission Tomography (PET) scan. This uses special radioactive dyes (radiotracers) to look at what is happening inside vein grafts. With this technique, the investigators will also be able to see what is happening to the heart, brain and wider parts of the body after CABG surgery. This study will aim to recruit 70 participants in total (maximum 150). 40 (maximum of 120) of these participants will have recently undergone CABG surgery and received ≥1 vein graft. The remaining 30 will have undergone CABG surgery ≥5 years ago and will have symptoms suggestive of vein graft failure. The study will last a total of 36 months and will involve participants undertaking the following assessments: 1. Total-body Positron Emission Tomography and Computed Tomography (PET-CT) scan 2. Ultrasound scan of the heart (echocardiogram) 3. A blood test - up to four tablespoons (60 mL) of blood will be taken for immediate testing and the remainder will be stored for future ethically approved studies.

Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

Apply CT angiography, CT perfusion imaging and advanced image processing techniques to improve revascularization decision-making and surgical strategies in patients undergoing coronary artery bypass graft surgery.

Distraction Therapy Using Virtual Reality in Cardiac Rehabilitation

The European Society of Cardiology has been putting forward the need for new adjuncts or models that optimise outcomes from CR programmes. Immersive virtual reality (IVR) is one of the newest technologies whose input in CR is currently being investigated. It is a technology which helps simulate the real environment through a virtual one, allowing for interaction with the environment and to carry out exercise with variability, where intensity, repetition and feedback are key elements. It is reported that immersion in VR environments diverts the attention of the patient from unpleasant bodily sensations, thus delaying the onset of boredom and fatigue. This is reported to possibly incite higher participation. In addition, VR has some noticeable indirect benefits for postcardiac event patients. It is reported that when using head-mounted devices during stationary cycling, a reduction in sympathetic tone and thus increase blood flow to the muscles prolonging the exercise duration and enhancing fatigue resistance will result. The use of distraction therapy through VR, one which isolates the patients from the medical context and puts all the attention on the virtual experience, makes the patient be distracted from the unpleasant stimuli of the surrounding environment. Distraction therapy through VR is reported to provide positive emotions, reduce anxiety and lead to an underestimation of the treatment duration.

Correlation of Euroscore-II, STS Risk Scoring Systems and Frailty Tests with Cardiac Histopathological Findings in Coronary Bypass Surgery

Various risk classification systems are used to predict postoperative mortality and morbidity development in cardiac surgery. Risk calculation with these systems is a guide in determining preoperative strategies, performing cost analyses, creating different treatment options and classifying diseases according to their severity. In recent years, tests defined as Frailty, which show how independently a person can perform daily living activities and are also associated with postoperative complications, have also been used. These tests allow for a personalized approach such as determining the most appropriate treatment options and pre- and postoperative rehabilitation. This study aims to evaluate the risk scores used to predict mortality during the preoperative preparation process in cases planned for elective Coronary Artery Bypass Graft (CABG) using the European System for Cardiac Operative Risk Evaluation (Euroscore)-II and Society of Thoracic Surgeons (STS) as well as Frailty with the Katz Index and modified Rockwood Clinical Frailty Scale, and to correlate the findings obtained from the histopathological study of the tissue sample taken from the right atrium during the operation with the test results. Secondary objectives are to investigate the compatibility of the age-related changes detected histopathologically with chronological age, to reveal which of the Frailty tests used gives better results in predicting mortality, and on the other hand, to reveal the relationship between Frailty tests and STS and Euroscore-II.

Enhancing Care Study in Patients After CABG

Review the data of patients who underwent coronary artery bypass grafting (CABG) at the National Center for Cardiovascular Disease, Fuwai Hospital from January 2013 to June 2023 including medical history, head CT scan, and postoperative, including 30-day mortality, arrhythmia, cerebrovascular disease and intracerebral haemorrhage, etc. Case-control and retrospective cohort studies were conducted to explore the risk factors associated with early postoperative complications, examine their relationship with postoperative management, explore independent risk factors of compound complications, and build predictive models.