Clinical Research Directory

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.

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 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.

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.

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.

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.

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.

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.

Drainage Technique in CABG

aims to compare the efficacy of the posterior pericardial window versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, while assessing their impact on hospital and ICU stay, pericardial effusions, re exploration for bleeding, post-operative blood transfusions, and mortality.

AI Model for Assessing Cardiac Surgeons' Techniques

The goal of this study aims to investigate the use of artificial intelligence to analyze and evaluate the characteristics and proficiency of surgeons during vascular anastomosis in coronary artery bypass grafting (CABG) procedures. The main question it aims to answer is: Consistency assessment between AI evaluation scores and human expert evaluation scores for surgeons during left anterior descending (LAD) artery anastomosis.

Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery

The RECOVER study, titled Cardiac Rehabilitation Cohort at the Medicine Campus Davos for Exploration of Recovery, is a prospective, non-interventional, monocentric cohort study conducted at the Hochgebirgsklinik Davos. The study is sponsored by Medicine Campus Davos AG and the Kühne Foundation, with an estimated start date in July 2025 and planned completion by December 2034, with the possibility of extension. The principal investigator of the study is PD Dr. David Niederseer from Hochgebirgsklinik Davos, who also represents the study. The research team includes co-investigators such as Prof. Dr. Stefan Blankenberg and Prof. Dr. Andreas Ziegler from Cardio-CARE, Medicine Campus Davos, as well as Dr. Jan Vontobel from Hochgebirgsklinik Davos. The study will enroll patients referred to Hochgebirgsklinik Davos for cardiac rehabilitation who provide informed consent. Cardiac rehabilitation is an evidence-based therapy for patients with heart disease, including those who have undergone cardiac procedures or surgeries. The primary objectives are to evaluate baseline patient characteristics, rehabilitation strategies, predictors of recovery, and clinical outcomes during and after rehabilitation. To support this, a detailed database and biobank will be established to allow for comprehensive phenotyping, extensive clinical assessments, and long-term follow-up. RECOVER seeks to gain translational insights into how patient-specific factors - such as genetics, plasma, digital and clinical biomarkers, and comorbidities - influence long-term clinical outcomes. The goal is to identify modifiable risk factors to optimize individualized therapeutic approaches in cardiac rehabilitation.

Perfusion Related Evaluation of Systemic and Renal Vulnerability to Events in CABG

The goal of this observational study is to learn whether high abdominal pressure or low blood flow pressure to the kidneys is linked to kidney injury after heart surgery. The main questions it aims to answer are: Does high abdominal pressure increase the risk of kidney injury after cardiac surgery? Can low blood flow pressure to the kidneys help predict who may develop kidney problems? Participants in this study are adults undergoing heart surgery, such as coronary artery bypass grafting (CABG) or valve surgery. Researchers will measure abdominal pressure and blood pressure continuously before and after surgery using medical devices that are already part of routine care. This study does not involve any changes to standard treatment. Participants will: Have their abdominal and blood pressures continuously monitored using existing devices Have blood and urine tests to check kidney function Be followed during their hospital stay and up to 30 days after surgery to assess outcomes like length of stay, readmission, and survival This study takes place at two hospitals-one in Poland and one in the United States. Researchers hope the findings will help identify early warning signs of kidney injury and improve monitoring practices after heart surgery.

The Effect of Virtual Reality and Eye Mask During Dressing After CABG Surgery

This study aims to evaluate the effects of virtual reality (VR) and eye mask (EM) applications on pain, anxiety, and physiological parameters during dressing after Coronary Artery Bypass Graft (CABG) surgery. Postoperative dressing procedures, especially after sternotomy, often cause significant pain and anxiety in patients. These issues can negatively impact recovery and increase the need for medication. Non-pharmacological interventions such as VR and EM may help reduce these symptoms. In this randomized controlled trial, 90 patients are divided into three groups: VR group, EM group, and a control group receiving standard care. Pain and anxiety levels are monitored baseline, immediately after, and 15 minutes after both the first and second dressing procedures. Physiological parameters are measured baseline, during, immediately after, and 15 minutes after both dressing procedures. Additionally, analgesic use is followed baseline and immediately after each dressing procedure. The study is conducted in a cardiovascular intensive care unit in Istanbul, Türkiye. It is expected that the findings will support the integration of VR and EM as effective, low-cost, and non-invasive options for postoperative care, improving patient comfort and healthcare quality.

Alpha Ketoglutarate Enhances Geroprotection In Surgery (AEGIS)

One of the most common major surgeries that older patients undergo is coronary artery bypass grafting surgery (CABG), which is performed in approximately 400,000 patients in the United States each year. CABG invokes a massive surgical stress response, with systemic epinephrine increasing 33-fold and norepinephrine increasing 3-fold. Initially, local tissue injury results in a sterile inflammation, releasing damage-associated molecular patterns (DAMPS). DAMPS activate neutrophils, bringing a cascade of cytokines, complement, and coagulation changes. Activation of nociceptors results in a neurometabolic response involving the sympathetic nervous system and hypothalamus-pituitary axis. This brings about systemic effects including changes in basal metabolic rate, hyperglycemia, lipolysis, negative nitrogen balance, and release of cytokines and complement. Although the surgical stress response is essential for wound healing and is usually self-limiting, an exaggerated response may occur resulting in multiple organ dysfunction. The acute phase of the surgical stress response is often followed by secondary insults that may be either sterile or pathogen-induced (such as postoperative infection).In the "two-hit" model of surgical stress response, there is an exaggerated response even to minor insults in vulnerable individuals who were primed by the initial stress response. Changes in the microbiome may also occur, developing a "pathobiome" that may enter the systemic circulation. If left unchecked, this second hit may result in the development of systemic inflammatory response syndrome (SIRS) and multi-organ failure. Chronological ageing changes the innate and adaptive immunity of patients. Biological hallmarks of aging such as genomic instability, mitochondrial damage, glycation of proteins, and cellular senescence all result in increased oxidative stress and systemic inflammation. Aging brings about a pro-inflammatory innate immune responsiveness that often occurs even in the absence of an inflammatory threat. This is termed inflammaging. Paradoxically, inflammaging is associated with an increased risk of infection and poor response to stressful events. At the same time, there is an age-associated loss of T-cell function, particularly in naïve CD8 T-cells. This deficit is termed immunosenescence and is characterised by reduced pathogen recognition, chemotaxis, and phagocytosis.

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.

Effect of Preoperative Sleep Intervention on Postoperative Delirium in Adult Patients Undergoing Cardiac Surgery

This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing cardiac surgery. The study will include adult patients undergoing coronary artery bypass grafting and/or valve surgery with concomitant sleep disorders, as assessed by the Pittsburgh Sleep Quality Index. All participants will be randomly assigned to placebo, placebo + cognitive behavioral therapy, and melatonin + cognitive behavioral therapy in a 1:1:1 ratio. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative cognitive function, sleep quality, and severity and duration of delirium. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.