Clinical Research Directory

A Randomized Controlled Trial: Fuzheng Yangxin Formula for ERAS After CABG

This study aims to evaluate the efficacy and safety of Fuzheng Yangxin Formula (FZYXF) in the treatment of qi-yin deficiency syndrome after coronary artery bypass grafting (CABG), formulate an integrated Chinese and Western medicine rehabilitation protocol, develop special proprietary Chinese medicines for postoperative patients, establish a postoperative rehabilitation database, and promote the standardized application and achievement transformation of integrated Chinese and Western medicine therapy in cardiac surgery.

The Impact of Left Stellate Ganglion Block on Systemic Inflammation and Neuromodulation in CABG Surgery.

((82)) patients scheduled to undergo elective CABG by the same surgical team will be allocated randomly by computer-generated random numbers into two equal groups (n= 41). Study groups: Group S (Stellate Ganglion Block Group): Patients will receive an ultrasound-guided Left stellate ganglion block prior to induction of general anesthesia. The block will be performed at the C6 level under strict aseptic precautions using 5 mL of 0.25% bupivacaine. Successful blockade will be confirmed by the appearance of ipsilateral Horner's syndrome. Group C (Control Group): Patients will receive standard perioperative care without stellate ganglion block and will undergo the same anesthetic and surgical management protocol as Group S.

Early Postoperative Physiotherapy to Prevent Respiratory Insufficiency After Elective Heart Surgery

This study aims to determine whether starting respiratory physiotherapy one hour after removal of the breathing tube following elective coronary artery bypass graft (CABG) surgery leads to better recovery than the current standard approach, in which physiotherapy begins on the first postoperative day. The study will evaluate whether earlier physiotherapy improves lung function, reduces postoperative pulmonary complications, shortens intensive care unit and hospital stay, decreases pain and anxiety, and improves overall recovery after surgery. The main question is whether very early postoperative respiratory physiotherapy provides additional benefits for patients recovering from elective heart surgery compared with standard postoperative care.

The 10-Year Extended Follow-up of the DACAB Trial

The goal of this observational study is to learn about the very long-term effects of different antiplatelet strategies in patients who underwent coronary artery bypass grafting (CABG) and participated in the original DACAB trial. The main questions it aims to answer are: Does one year of treatment with ticagrelor plus aspirin (dual antiplatelet therapy) after CABG reduce the risk of major adverse cardiovascular events (MACE) over 10 years compared with aspirin alone or ticagrelor alone? What are the long-term safety outcomes, including major bleeding events, among patients who received different antiplatelet strategies? Researchers will compare the three originally randomized groups (ticagrelor plus aspirin, ticagrelor alone, and aspirin alone) to see if a one-year course of dual antiplatelet therapy provides a sustained clinical benefit over a decade. Participants will: Be contacted by telephone by the central study team for a one-time follow-up interview. Provide information about their current health status, any cardiovascular events (such as heart attack, stroke, or repeat revascularization procedures) that have occurred since the last follow-up. Report their current use of medications, including antiplatelet and other cardiovascular drugs. Allow researchers to request relevant medical records to verify any reported clinical events.

Nonintubated Anesthesia for Adult Cardiac Surgery With Cardiopulmonary Bypass

The goal of this prospective, multicenter, randomized clinical trial is to learn whether a nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing can reduce postoperative pulmonary complications and improve early recovery in adults undergoing elective cardiac surgery with cardiopulmonary bypass. The main questions it aims to answer are whether, compared with conventional endotracheal fast-track anesthesia, the nonintubated strategy can reduce pulmonary complications within 30 days after surgery, reduce the need for postoperative invasive mechanical ventilation and other respiratory support, and shorten the time spent in the intensive care unit. Participants will be randomly assigned to undergo cardiac surgery using either a standardized nonintubated supraglottic airway anesthesia strategy with early restoration of spontaneous breathing or a conventional endotracheal fast-track anesthesia strategy. Both groups will receive standardized perioperative care, with objective criteria for airway removal and readiness for discharge from the intensive care unit. Endotracheal intubation or escalation of respiratory and circulatory support will be performed whenever clinically necessary. Participants will be followed from screening through hospitalization, at 30 days after surgery, and for up to 1 year. Routine perioperative data and key postoperative outcomes, including pulmonary complications, respiratory support, intensive care unit stay, major organ complications, safety events, recovery, rehospitalization, and survival, will be collected.

Structured Inpatient Physiotherapy in High-Risk Coronary Artery Bypass Grafting Patients

Coronary artery bypass grafting (CABG) may be associated with prolonged recovery, particularly in high-risk patients. Although preoperative rehabilitation has shown promising results, evidence remains limited because of heterogeneous intervention protocols and variations in postoperative care. This study aims to investigate the effects of a structured inpatient physiotherapy program initiated at least two days before surgery and continued postoperatively, compared with the same structured physiotherapy program provided only during the postoperative period, in high-risk CABG patients. The primary outcome is hospital length of stay. Secondary outcomes include intensive care unit length of stay, C-reactive protein, neutrophil-to-lymphocyte ratio, hemoglobin, dyspnea, and fatigue.

Clinimetric Properties of Performance Based Functional Outcome Measure After (CABG) Surgery

The purpose of this research is to determine which performance based functional outcome test among Time up and go test, Five times sit to stand test, 2 minute walk test and 6 minute walk test has the greatest significance in improving functional outcomes in post-CABG surgery patients.

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.

Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells

The primary goals of this study are to compare the differences in tissue-resident Treg gene signature for activation, proliferation, and suppressive function using single-cell/-nucleus RNA sequencing in patients treated with ld-IL-2 compared to control grouped by individual tissue beds from in and around the heart. Additionally, tissue-resident Tregs will be compared to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2 on the two compartments.

Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery

The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery. Specifically, this research aims to investigate differences in pressure injury outcomes before and after the intervention, and to assess the preventive effectiveness of soft foam dressings as an adjunctive skin-protection strategy.

Dietary Supplements in Patients With Coronary Artery Bypass Grafting for Improving the Quality of Healthcare Delivery.

Cardiovascular disease (CVD) remains the leading cause of death worldwide. Prevention of CAD by targeting modifiable factors remains a key public health priority. L-Ascorbic Acid (Vitamin C - Vit. C) and Omega 3 fatty acids, Eicosapentaenoic / Docosahexaenoic Acid (EPO/DHA), powerful but also necessary antioxidants for the human body, after observational studies as well as randomized studies seem to have a beneficial effect in the direction of the prevention of CVD with pleiotropic mechanisms. Lignin, a polymer of plant origin that is considered a dietary fiber, has a developed porous structure and can retain exogenous and endogenous toxins, and pathogenic microorganisms. Lactulose considered a prebiotic provides a selective substrate for the metabolism of saccharolytic bacteria with bifidogenic activity and multiple benefits to the host's gut health. Coronary artery bypass grafting (CABG) is an established surgical intervention and treatment of symptoms of myocardial ischemia that improves patient survival Optimal Medical Therapy (OMT) after coronary arterial bypass grafting (CABG) as described in current clinical practice could be made even better by the addition of these beneficial food supplements. A randomized controlled trial is proposed in an intervention group of 54 post-CABG patients who will be given daily orally in addition to the usual medication, 1000 mg Vitamin C, 840 mg EPO/DHA, 2130 mg Lignin \& 720 mg Lactulose and a control group of 54 patients (Control Group) in which only usual medication will be administered. The intervention will take place from the 15th postoperative day when CAGB patients are discharged and lasts for 2.5 months (10 weeks) postoperatively. The data will be collected on the 15th, 80-90th postop day in 6 months and 12 months postop and then the statistical analysis of the data will be performed. Considering the number of CABG surgeries performed electively in our clinic, this study is expected to be completed in approximately 2-3 years from the day of initiation. The expected knowledge through the expected results such as these will emerge from this study is the potentially beneficial effect of our food supplements administration (intervention), i.e. Vitamin C, EPO/DHA, Lignin \& Lactulose, on the postoperative course of our patients. Some degree of improvement in the well-being and clinical picture of our patients postoperatively is expected, which will be thoroughly investigated in each phase of the study.

Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL)

This randomized multicenter trial compares coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in 358 patients with ischemic left ventricular dysfunction and multivessel coronary disease. The study evaluates differences in survival, major cardiovascular events, and quality of life over 4 years, and contributes to the international STICH 3.0 collaboration assessing long-term outcomes.

Effects of E-care Protocol in Patients With Coronary Artery Bypass Graft

Coronary artery disease (CAD) is a heart disease caused by the buildup of plaque inside the coronary arteries that restricts blood flow to the heart which leads to heart attack. If it involve more than one artery it will be more critical so the preferred treatment will be coronary artery bypass graft. Respiratory failure after Coronary Artery Bypass Grafting (CABG) is a serious complication with multifactorial causes i.e. pneumonia and atelectasis in inpatients. Postoperative pulmonary complications will be diagnosed using the Melbourne Group Scale (MGS), applied daily from postoperative day 1 to day 7. A score of ≥4 positive criteria will be used to identify PPCs. The scale's criteria will include chest radiograph findings, oxygen saturation, sputum characteristics, inflammatory markers, and ventilation data, physician diagnosis of pneumonia, readmission to ICU for respiratory reasons, prolong ventilation\> 24 hours, unplanned use of non-invasive ventilation.

Low-dose Colchicine for CABG Graft Failure Prevention

This study aims to evaluate whether daily low-dose colchicine (0.5 mg), administered in addition to the standard secondary prevention regimen recommended in clinical guidelines after coronary artery bypass grafting (CABG), can further prevent graft failure after CABG through a prospective, randomized, double-blind, placebo-controlled clinical trial.

The Relationship Between Blood Flow Readings During Surgery and How Well the Graft Stays Open and How Patients Recover Afterward in Coronary Artery Bypass Graft Surgery

The purpose of this study is to learn more about a tool called Transit-Time Flow Measurement (TTFM). TTFM uses sound waves during surgery to check how well blood is flowing through blood vessels. This helps doctors see if the blood flow is good during coronary artery bypass grafting (CABG), which is a type of heart surgery

The CDAC Study - Cerebral Dysfunction After Coronary Revascularization

Neurocognitive decline has long been suspected to be a potential long-term complication of coronary artery bypass grafting surgery (CABG), with reports of post-operative cognitive dysfunction by objective testing approaching 15-50% of patients in the year following surgery. To determine the true rate of long-term cognitive dysfunction following CABG compared to percutaneous coronary intervention (PCI or coronary stent placement), we propose a multi-center, two-group, non-randomized study using computer-based customized neurocognitive testing (Cogsate), prior to the procedure and then at 30 days, 1-year and 2-years after revascularization to evaluate cognitive function vital for the maintenance and advancement of professional and personal activities. It is anticipated that the study will document a higher rate of cognitive dysfunction in the CABG group, that the landmark study will provide both the patient and physician with the information necessary to make an informed decision regarding the cognitive risks of CABG versus PCI when faced with the need for coronary revascularization, and that these results will change the clinical practice of recommending CABG as a primary revascularization option for those wishing to preserve cognitive function.

Risk Stratification of MACE in Heart Failure Patients Who Undergoing CABG

PROFILE-HF is a multicenter, observational, prospective study of the clinical course and outcomes of chronic heart failure (HF) and coronary artery disease (CAD) in patients undergoing coronary artery bypass grafting (CABG). The objective of the study is to develop a method for assessing the risk of adverse cardiovascular events in patients with CAD and HF who have undergone CABG, based on preoperative GDF-15 concentrations. The study will have a 12-month follow-up period; one in-person visit is planned at the end of the follow-up period. If it is not possible to visit a doctor in person, information will be collected through telephone contact with the patient or his relative or person caring for the patient.

Impact of Visceral Adiposity on Postoperative Atrial Fibrillation After CABG

Obesity has become a major public health problem in both developed and developing countries, with a continuous increase particularly since the 1980s. Moreover, it is a well-established metabolic risk factor for diabetes mellitus, hypertension, and various types of cancer, as well as cardiovascular diseases such as heart failure and coronary artery disease. Body mass index (BMI) is calculated by dividing body weight in kilograms by the square of height in meters and is widely used as an indicator of obesity. However, BMI does not quantitatively reflect body fat distribution and fails to account for components such as skeletal muscle and bone mass. Therefore, interest in assessing body fat distribution has increased, and in recent years, studies evaluating the correlation between anthropometric, biochemical, and anatomical measurements and clinical outcomes have become more frequent. In particular, it is acknowledged that abdominal obesity cannot be accurately represented by BMI alone and is primarily associated with visceral adipose tissue (VAT). The aim of this study is to evaluate the association between preoperative visceral and subcutaneous adipose tissue measurements (VAT and SAT), assessed by ultrasonography in patients scheduled for open-heart surgery, and the development of postoperative atrial fibrillation.

Comparative Analysis of Analgesic Approaches in the Early Period After CABG

The goal of this clinical trial is to study postoperative analgesia in patients undergoing CABG. And learn if tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) treats pain not inferiory then morphine. The main questions it aims to answer are: Does tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) lower the VAS score same way as a morphine? What medical problems do participants have when taking tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid)? Participants will: Group (1)- subcutaneous single dose of morphine 10 mg would be administred based on VAS score \> 3 during 24 hours after CABG. Exprimental group (2)- subcutaneous single dose of tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) - 0.4 mg would be administred based on VAS score \> 3 during 24 hours after CABG. Efficacy was assessed using the VAS scale decreassion. Hemodynamic parameters and arterial blood gases were also assessed.

Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages

The study aimed to assess the efficacy of customized pressure-guided elastic bandages (CPG-EB) in preventing postoperative edema and complications in Coronary Artery Bypass Graft (CABG) patients. While compression therapy, like compressive stockings, has benefits in preventing edema, concerns about affordability persist. CPG-EB provides optimal sub-bandage pressure, proven effective in venous leg ulcers. Implementing CPG-EB post-CABG could enhance venous blood flow, reducing complications and improving outcomes. Patients were divided into two groups: one with CPG-EB and the other standard post-CABG care. Data collected at 1, 2, and 6 weeks post-surgery assessed swelling and wound complications. Comparative analysis used standardized criteria.

Role of Opioid Free Anaesthesia in Elderly Patients Undergoing Elective Coronary Artery Bypass Graft Surgeries With Cardiopulmonary Bypass in Enhanced Recovery After Surgeries

The introduction of synthetic opioids in 1960 to general anesthesia together with sedative hypnotics and muscle relaxants allowed the appearance of the concept of multimodal balanced anesthesia. Although they help in achieving hemodynamic stability during anesthesia of open heart surgeries, their administration consequences are neither scarce nor benign to the patient. Perioperative opioids are associated with increased incidence of respiratory depression, prolonged mechanical ventilation, nausea and vomiting, prolonged sedation, Postoperative ileus (POI), urine retention, Postoperative cognitive dysfunction (POCD), immune depression and hyperalgesia (Beloeil et al., 2018). Coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) is particularly vulnerable to the above-mentioned complications. Indeed, some of the side effects of this surgery overlap with the adverse effects of opioids. Postoperative pulmonary complications are observed in up to 50% of patients (Fisscher et al., 2022) and POCD or delirium in 4-54% according to studies (Bhushan et al., 2021). Whereas major gastrointestinal complications are estimated to occur in around 3% of patients, essentially acute pancreatitis, postoperative ileus (Marsoner et al., 2019). Opioid-free anesthesia (OFA) strategies have emerged to avoid intraoperative opioid use. It is based on the fact that a sympathetic reaction evidenced by hemodynamic changes in an anesthetised patient does not systematically reflect pain. In addition, a sleeping patient will not recall pain, while hormonal stress and sympathetic and inflammatory reactions can be controlled by therapeutic classes

Multimodal VR Rehabilitation for Cardiorespiratory Fitness in CABG Phase II

It will be a randomized clinical trial with a sample size of 66. A convenient sampling technique will be used to recruit the CABG phase II patients for the study. Then, they will be divided into three groups by block randomization. Weight-bearing Liuzijue Qigong will be given as a baseline treatment to all groups. In group A, patients will engage in multimodal circuit training while simultaneously viewing the nature scenes through VR in a clinical setting, in group B, patients will be given multimodal circuit training in a clinical setting while in group C, patients will be given multimodal circuit training through telerehabilitation. The dyspnea 12 Questionnaire will be used for measuring dyspnea, Cooper's 12-minute test will be used to assess cardiorespiratory fitness, echocardiography will be used to assess Left ventricular ejection fraction, EQ-5D-5L will be used to assess quality of life, and Pittsburgh Sleep Quality Index (PSQI) will be used to assess the quality of sleep. Data will be entered and analyzed through SPSS version 21.

Pilot Trial of Colchicine for Graft Failure in CABG

The goal of this pilot trial is to to evaluate the preliminary effect of oral colchicine therapy on graft outcomes in patients underwent primary isolated CABG. The main questions it aims to answer is: 1. Whether the oral colchicine therapy may reduce the failure outcome of grafts after CABG. 2. Whether it is feasible to construct a muticenter powered trial to test the superiority hypothesis. Researchers will compare colchicine to none to see if colchicine works. Participants will 1. Take oral colchicine (0.5mg daily) therapy for 12 months after CABG. 2. Clinical follow-up at Month 1, 6, and 12 after CABG. 3. Protocol-driven CCTA at Week 1 and Month 12 after CABG.

CLEAR Trial: CA330 Cytokine Adsorption Column for Anticoagulant/Antiplatelet Patients in Non-Elective CPB Surgery.

The goal of this clinical trial is to evaluate whether the CA330 cytokine adsorption column can reduce perioperative severe bleeding adverse events in patients receiving anticoagulant and/or antiplatelet therapy who undergo non-elective cardiac surgery with cardiopulmonary bypass. The main questions it aims to answer are: * Does the use of the CA330 cytokine adsorption column lower the incidence of perioperative severe bleeding compared with standard care? * Does the intervention improve short-term clinical outcomes, such as transfusion requirements, reoperation rates for bleeding, or overall postoperative recovery? If there is a comparison group: Researchers will compare patients treated with the CA330 cytokine adsorption column versus patients receiving standard cardiopulmonary bypass management to see if cytokine adsorption provides additional safety and efficacy benefits. Participants will: * Undergo non-elective cardiac surgery requiring cardiopulmonary bypass. * Be randomly assigned to receive either the CA330 cytokine adsorption column integrated into the CPB circuit (intervention arm) or standard CPB management without the device (control arm). * Be monitored for perioperative bleeding outcomes, transfusion needs, reoperation rates, and overall postoperative prognosis.