Cardiac Surgery

Researchers are evaluating an AI-assisted digital health tool called the "Smart family doctor" to improve control of hypertension, diabetes, and dyslipidemia in adults who have undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). This study uses a randomized controlled design involving about 536 participants across 5-10 hospitals. Participants must be adults aged 18 or older with a history of CABG or PCI and the specified conditions. Participants in the experimental group will use the AI-assisted "Smart family doctor" app that provides personalized health education, targeted guidance on managing blood pressure, blood sugar, medication adherence, exercise, and smoking cessation. They will also receive tailored reminders and can report self-measured health data for feedback. Both groups receive weekly 3-hour health management guidance from health managers, and participants will wear a smart band daily for health data collection during the 6-month study period. Throughout the study, participants will be assessed for control rates of hypertension, diabetes, and hyperlipidemia at 6 months. Additional measures include blood pressure, cholesterol levels, blood glucose, physical activity, quality of life, psychological status, and cognitive function. The study monitors health data continuously via smart bands and collects self-reports and clinical assessments to evaluate the intervention's impact over the 6 months.

Researchers are studying recovery after heart surgery for people with Complex Congenital Heart Disease (CCHD) to understand the main risk factors affecting recovery. The study also aims to build a comprehensive data platform to support CCHD care throughout a person's life and develop a China-specific quality control system to improve surgical outcomes and guide national health policies. The study includes two groups: a retrospective group of 2,494 patients who already had CCHD surgery and are in an existing national database, and a prospective group of 1,940 patients scheduled for surgery as part of related sub-studies. Data collected include pre-surgery tests, surgical details, care during and after surgery, and follow-up for up to one year. Researchers will combine data from both groups to build a new registry and quality control system. Participants will have their medical records analyzed or have data collected during their care, depending on their group. Researchers will monitor recovery and outcomes up to one year after surgery, using the combined data to identify risk factors and develop a surgical quality control system. The study spans up to 48 months, aiming to improve CCHD care across all ages in China.

Researchers are studying patients with acute coronary syndrome who undergo percutaneous coronary intervention to understand the risk factors that affect the occurrence and prognosis of this condition. This observational study will follow participants for at least two years to track major adverse cardiovascular events, including all-cause mortality, cardiovascular mortality, and ischemic stroke. The study is led by Su Guohai and aims to gather comprehensive data to improve knowledge about acute coronary syndrome outcomes. Participants will have blood and fecal samples collected for detailed analysis. Clinical information such as diagnosis, medical history, lab test results, treatment methods, prognosis, and follow-up data will also be recorded. The study focuses on monitoring the progression and outcomes of acute coronary syndrome over time through regular data collection. During the study, participants will be closely followed up to document any major cardiovascular events over a two-year period and beyond. Researchers will assess various health measures and risk factors to better understand how acute coronary syndrome develops and progresses. The total duration of participation includes initial enrollment and ongoing observation to capture long-term outcomes.

Researchers are evaluating the use of Near Infrared Spectroscopy (NIRS) to predict acute kidney injury (AKI) in adult patients undergoing cardiac surgery with cardiopulmonary bypass. AKI is a common and serious complication after such surgeries, leading to increased hospital stays, costs, and mortality. This study aims to compare the effectiveness of NIRS sensors placed on the skin over the kidney versus sensors placed on the limbs for predicting AKI. The research is conducted by the University of Utah's anesthesiology department. Participants will have NIRS sensors placed on the skin over their kidney, as located by ultrasound, and on the muscles of their arm and thigh before surgery. If a patient has had a right nephrectomy, the sensor will be placed over the left kidney. Additional sensors will be placed on the forehead to measure brain oxygen levels during surgery. The study observes how well these sensor placements predict AKI from the day of surgery up to seven days afterward. During the study, participants will undergo ultrasound measurements to determine the depth of kidney and muscle tissue before sensor placement. Researchers will monitor oxygen levels in various tissues throughout surgery and track outcomes such as AKI development, ventilator times, length of hospital stay, and in-hospital mortality up to three months. Hemodynamic data including blood pressure, oxygen delivery, vasopressor use, and anemia during surgery will also be recorded. The total observation period extends from surgery through hospital discharge and follow-up for up to three months.

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index (MDPI) to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass (CPB). This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts: first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions; second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables; and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

Researchers are conducting an observational, multicenter cohort study called the SweD-HTx study, involving adult heart transplant recipients from three Swedish university hospitals. The study aims to develop a nationwide protocol for monitoring transplant rejection using donor-derived cell-free DNA (dd-cfDNA) and to better understand rejection mechanisms and immune activation. This study focuses on adults who have undergone orthotopic heart transplantation, with exclusion of those who are pregnant or have had multiple organ or stem cell transplants. Participants receive routine post-transplant care including endomyocardial biopsies at scheduled intervals. Blood samples are collected alongside these biopsies for dd-cfDNA and donor-specific antibody (DSA) analysis, using next-generation sequencing and standardized laboratory procedures. The study will analyze the relationship between dd-cfDNA levels and biopsy-confirmed rejection, following international histopathological criteria. The collection of clinical and demographic data from electronic medical records supports comprehensive analysis. Participants are monitored over several years with blood sampling coordinated with routine biopsies during the first two years post-transplant and annual data collection up to five years. Outcomes include the correlation between dd-cfDNA fraction levels and biopsy-proven rejection, longitudinal changes in dd-cfDNA and DSA, and their association. Safety and standard care continue throughout, with data securely managed and analyzed to improve rejection monitoring methods in heart transplantation.

This research aims to improve anticoagulation management in patients using extracorporeal membrane oxygenation (ECMO) for severe respiratory and/or circulatory failure. ECMO treatment is linked to a high rate of bleeding and clotting complications, which significantly increase the risk of death. Optimizing the way anticoagulation is controlled during ECMO is an urgent scientific priority to reduce these adverse events. The study compares two anticoagulation approaches during ECMO. One group receives a combination of nafamostat and unfractionated heparin, with doses adjusted to keep blood clotting times at specific target ranges both systemically and within the ECMO membrane lung. The other group receives only unfractionated heparin with doses adjusted to maintain blood clotting time within a higher target range during ECMO. Participants are randomly assigned to one of these treatment groups. Participants will be closely monitored for bleeding or clotting events related to ECMO over a 28-day period. The study will measure how often these complications occur as the primary outcome. Researchers will track anticoagulation levels through blood tests to adjust medication doses. The entire trial is planned to run until December 31, 2027, with ongoing safety and effectiveness assessments throughout the study period.

Researchers are evaluating the safety and effectiveness of a human umbilical cord mesenchymal stem cell injection called B2278 in combination with coronary artery bypass grafting (CABG) surgery for treating chronic heart failure caused by chronic ischemic cardiomyopathy. This multi-center Phase I/II clinical trial aims to find the best dose and treatment schedule for injecting B2278 directly into the heart muscle during surgery. Preliminary studies suggest B2278 may help repair the heart by reducing inflammation, promoting blood vessel growth, and regulating immune responses. Participants will undergo CABG surgery combined with different doses of B2278 injected into the epicardium, including low, medium, and high doses, or CABG surgery alone without B2278. The trial compares these four groups to explore the safety, tolerance, and heart function effects of adding B2278 to surgery. This approach focuses on direct heart treatment during CABG to address chronic heart failure caused by ischemic damage. During the study, participants will be monitored through various heart function tests such as cardiac magnetic resonance imaging and echocardiography at scheduled intervals up to six months after treatment. Researchers will assess safety events, heart pumping efficiency, heart size, walking ability, quality of life, and heart failure symptoms. Follow-up visits will include questionnaires, imaging, and blood tests to track changes and ensure participant safety throughout the trial period.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery. This observational study aims to assess the device's performance in real-world settings, focusing on the rate of successful vessel connection in the first surgical attempt and the absence of device-related adverse events. Participants will receive standard surgical care using the Symani Surgical System, which offers articulated, interchangeable instruments designed for open microsurgery procedures. The study includes patients undergoing free tissue transfer of the breast or extremities and those having lymphovenous anastomosis surgery for lymphedema. During the trial, participants will have their surgical procedures assessed and may complete questionnaires if undergoing lymphedema procedures. Throughout the study, researchers will monitor the safety and effectiveness of the device by evaluating intraoperative vessel patency and tracking any adverse events up to 30 days after surgery. Participants will be asked to allow access to their medical information, attend follow-up visits, and complete all study procedures and questionnaires. The total participation covers the surgery period and a 30-day post-surgery follow-up to ensure comprehensive safety and outcome monitoring.

Researchers are evaluating a wearable device designed to continuously monitor lactate levels in the body for patients undergoing planned coronary artery bypass graft (CABG) and/or valve replacement surgery. The goal is to compare the device's readings with standard blood tests to verify accuracy. If successful, this device could reduce the need for frequent blood tests during surgery recovery and may also help in emergency rooms, especially for patients with chest pain. The study is conducted at Barts Hospital and sponsored by Queen Mary University of London. Participants will have two lactate sensors placed on their upper arm up to five days before surgery, with a 24-hour warm-up period before continuous measurement begins. During and after surgery, the sensors will monitor lactate levels for up to 48 hours. Hourly blood samples will be taken for up to 14 hours during surgery to compare with the sensor readings, including measurements of arterial and venous lactate, as well as venous troponin. Vital signs such as blood pressure, heart rate, and respiratory rate will be monitored regularly, and any medication changes will be recorded. Participants will undergo assessments including ECGs, blood pressure, heart rate, respiratory rate, and blood tests both before and after surgery. The sensors will be removed within 48 hours post-surgery, and the skin will be checked for any reactions. Follow-up monitoring will continue for up to 24 hours after sensor removal or until hospital discharge. Researchers will evaluate the device's accuracy, functionality, and safety through continuous lactate sensor measurements compared to standard blood tests over 14 to 48 hours, and safety monitoring up to 8 days.