Clinical Research Directory

Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy

Rationale Cardiac surgery via median sternotomy carries an elevated risk of postoperative complications and delayed functional recovery. Preoperative physical therapy aims to reduce the incidence and severity of postoperative adverse outcomes and to accelerate functional recovery. However, current evidence on prehabilitation is inconsistent due to methodological heterogeneity. This study addresses the limitations of previous studies in four ways. First, a validated preoperative prediction model is used to select patients at high risk of in-hospital postoperative complications and delayed functional recovery. Second, a Cardiopulmonary Exercise Test (CPET) is performed at baseline to guide safe and effective intensity prescription. Third, as different patient populations are expected to benefit from different training programs, the prehabilitation program is tailored to the surgical indication: patients undergoing coronary artery bypass grafting (CABG) receive high-intensity interval training (HIIT), and patients undergoing aortic valve replacement (AVR) receive moderate continuous training. Fourth, physical activity and self-management are promoted by using a wearable physical activity monitor and Shared Decision-Making (SDM) to stimulate and track daily physical activity. Primary Objective To investigate the feasibility of a personalized, procedure-specific prehabilitation program (four to six weeks) for high-risk patients scheduled for elective cardiac surgery via sternotomy, with respect to recruitment, adherence, drop-out, safety, and acceptance. The program consists of two physiotherapist-supervised group training sessions per week, promotion of physical activity, and unsupervised home-based exercise. Secondary Objective To provide a preliminary evaluation of participant responses to the intervention, focusing on changes in cardiorespiratory fitness (WRpeak), peripheral muscle strength (1RM), inspiratory muscle strength (MIP), physical activity (time spent active per day), and health-related quality of life (SF-36). Study design A prospective, single-center, longitudinal, mixed-methods pilot study conducted at Maastricht University Medical Center (MUMC+). Study population High-risk patients (n=24), defined by EuroSCORE II, who are scheduled for elective cardiac surgery via sternotomy (CABG or AVR). Main study parameters/endpoints The primary endpoint is the feasibility of the prehabilitation intervention with respect to recruitment, adherence, drop-out, safety, and acceptance. Burden Participation involves a structured time commitment with clinic and home components. Total supervised clinic time is estimated at 11-15 hours, covering two baseline assessments, 8-12 training sessions, and the final evaluation and interview. Total time at home is estimated at 16.5-19 hours, covering daily diary completion and unsupervised home exercises. These ranges depend on the patient's time to surgery. Risks and mitigation The risk of acute cardiac events during exercise is elevated in this high-risk population. This risk is mitigated by strict adherence to NVVC/MUMC+ absolute stop criteria, continuous medical supervision during all testing and training sessions, and individualized intensity prescription based on CPET. The risk is considered acceptable in relation to the scientific value of studying this specific high-risk cohort, which makes the study group-related. Benefit and group relatedness Direct clinical benefit cannot be guaranteed, as this is a feasibility study. However, patients receive an intensive, personalized prehabilitation program that is designed to reduce the incidence and severity of postoperative adverse outcomes.

Epigenetic Susceptibility to Inflammatory Complications After Cardiac Surgery

This study aims to better understand 3 crucial questions: 1. Why do some patients experience more severe complications after heart surgery than others? 2. Are there markers on our genetic makeup (called epigenetic modifications) that can predict complications after major surgery? 3. How do epigenetic modifications lead to overactive inflammation that causes harm to patients after heart surgery? Over 270,000 patients undergo major surgery in Scotland each year. Major surgery is associated with increased risk of complications, particularly in older patients with multiple health conditions. Complications are a leading cause of death, delayed recovery, long-term illness and increased healthcare cost to the NHS. Significant complications occur in up to 57% of patients after heart surgery. In response to major surgery, the body stimulates an inflammatory response as part of a complex repair mechanism, however, in some cases inflammation can become exaggerated, becoming harmful and contributing to the development of complications. The investigators believe that a patient's risk of overactive inflammation, which can lead to complications after surgery, is heavily influenced by a patient-specific system of biological markers, layered upon their DNA; a scientific field known as epigenetics. Where a patient's DNA (their 'genetics') may be considered as an instruction manual for each cell's molecular processes, these 'epigenetic' markers work as if someone has highlighted sections of the manual to be read (and actioned). The pattern of these markers on immune system cells can therefore dictate the extent of the inflammatory response, especially after a major insult such as surgery. While the DNA itself cannot be modified, epigenetic markers can be modified, through strategies including diet, exercise, and medication. The aim of this study is to evaluate whether the modifiable epigenetic code of key immune-system cells dictates the extent of post-operative inflammation, contributing to organ damage and complications. With patients' permission, the investigators will: 1. Obtain blood samples before and after major heart surgery, to test for epigenetic markers and inflammation. 2. Observe patients after surgery and collect routine data from laboratory tests and patient observations which assess for organ dysfunction and inflammation. 3. Conduct patient questionnaires before and after surgery to assess physical fitness and patient-centred quality of life measures. 4. Analyse patterns between patients who have severe organ dysfunction after surgery and those patients who have minimal organ dysfunction after similar surgery, to better understand which patients are at greatest risk, according to their epigenetic makeup. This study may improve understanding of which patients are likely to suffer organ damage and complications after major surgery, and which patients may have a protective epigenetic makeup which reduces complications. With this knowledge, the investigators aim is that future patients could receive personalised treatment plans before surgery, to modify their epigenetic makeup, reduce harm from complications and improve outcomes for patients. The investigators are not testing any new treatments in this study.

DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease

DAN-RELEASE is a national, randomized, registry-based trial including 7,000 participants in Denmark. The trial aims to determine whether discontinuation of long-term aspirin therapy is non-inferior to continued aspirin therapy in older adults with stable ischemic heart disease. Long-term aspirin therapy is recommended for patients with established ischemic heart disease. However, among clinically stable patients years after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or myocardial infarction (MI), the evidence supporting lifelong aspirin therapy is limited. At the same time, the risk of serious bleeding increases with age. DAN-RELEASE will therefore compare aspirin discontinuation with continued aspirin therapy in adults aged 65 years or older with stable ischemic heart disease who have remained free from ischemic events for at least two years. The trial will assess whether discontinuing aspirin is non-inferior to continued treatment with respect to cardiovascular and bleeding outcomes.

The Safe Early Mobilization on CABG

Aim: This study aimed to evaluate the effect of a Safe Early Mobilization Protocol (SEMP) developed for patients undergoing coronary artery bypass graft (CABG) surgery on patient outcomes. Design: A single-center, parallel-group, randomized controlled trial. Methods: The study was conducted with 60 patients in 2023. The intervention group received a Safe Early Mobilization Protocol including bedside elevation, deep breathing and coughing exercises, sitting upright in bed, sitting on the edge of the bed, standing, ambulation, and sitting in a bedside chair from the day of surgery until the fourth postoperative day. The control group received routine mobilization care. Respiratory parameters, orthostatic hypotension (OH), orthostatic intolerance (OI), mobilization distance, anxiety level, and hospital stay were evaluated.

Different Anti-Spastic Therapy Strategies After CABG Using Radial Artery Grafts

The Pilot study will be a single-center, randomized, open-label, active-controlled trial. After CABG surgery using Radial Artery Grafts (RA-CABG) and signing the informed consent, all patients will be screened according to the inclusion and exclusion criteria. Estimated 150 patients will be enrolled and randomized by ratio 1:1:1 to receive either Nicorandil (5mg tid po) or Diltiazem (180mg qd po) or Isosorbide Mononitrate (50mg qd po). Follow-up visits will be conducted at Week 1, 4, 12, and 24 after surgery. The last evaluation of study endpoints and other adverse events will be at Week 24. The pilot study is designed to explore the angiography outcomes of grafts and cardiovascular outcomes of patients, as well as safety outcomes among different anti-spastic regimens after RA-CABG. The original study plan included a 24-week follow-up to evaluate the effects of different antispasmodic medications on radial artery grafts. The study protocol has been updated to include a centralized follow-up at a median of 5 years post-surgery. During this follow-up, patients' survival status, imaging results of graft vessels, and major cardiovascular events will be collected via outpatient visits or telephone interviews, with the aim of evaluating the impact of different antispasmodic strategies on long-term clinical outcomes and graft patency.

Micro- and Macro-Circulation in Cardiac Surgery Patients

The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening, death). The state of sublingual microcirculation, of peripheral microcirculation and cardiovascular control will be assessed in 100 patients undergoing cardiac surgery during general anesthesia before the intervention and at the end of the intervention at the arrival in post-surgery ICU by means of signal processing techniques. The extracted markers will be used to assess a statistical prediction model of major morbidities.

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.

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.

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.

Effect of Active Cycle of Breathing Technique as Add on to Routine Chest Physical Therapy on Respiratory Parameters in Coronary Artery Bypass Graft Patients

A controlled trial was conducted to determine the effect of the active cycle of breathing technique (ACBT) in improving respiratory parameters after coronary artery bypass graft surgery. The main aim of this study was to determine the effects of pre and postoperative active cycle of breathing technique (ACBT) in coronary artery disease patients undergoing coronary artery bypass graft surgery in improving respiratory parameters such as arterial blood gas (ABG), oxygen saturation (SpO2) and respiratory rate. The intervention group performed an active cycle of breathing technique with routine chest physical therapy while the control group performed routine chest physical therapy. Arterial blood gas (ABG), oxygen saturation (SpO2), and respiratory rate were measured at baseline and five days after surgery, every 2 hours on postoperative days 1, 2, and 3 and 4 hours on days 4 and 5. Participants in the intervention group performed preoperative routine chest physical therapy sessions were followed as: * Incentive spirometry, 3 sessions per day, 10 repetitions * Percussions, 3 sessions per day, 20 repetitions * 3-minutes walking, 2 sessions per day * ACBT, 3 sessions per day The preoperative chest physiotherapy treatment plan was continued after CABG surgery. In addition to these, the following were included postoperatively: * Nebulization, 3 sessions per day * 3 minutes of walking, 2 sessions per day * ACBT, 3 sessions per day While participants in the control group performed the same pre and postoperative sessions except ACBT.