Clinical Research Directory

Unrecognised Comorbidity Detection in Hospitalised Patients

Over two million people in the UK are unaware that they're living with a long-term (chronic) health condition, such as diabetes or a heart problem. These chronic conditions can lead to serious complications such as heart attacks, strokes, and kidney problems. By diagnosing these conditions earlier, effective treatments can be started sooner which will reduce the risk of harm. However, diagnosis relies on people having symptoms and contacting their doctor or attending NHS Health Checks. There are over 16 million admissions to English hospitals each year. Hospitals collect a lot of information during a hospital stay including patients' age, blood test results and blood pressure measurements. Research has shown that this information can be helpful in spotting people with chronic conditions. This study aims to design and test a digital platform to find the patients in hospital who are most likely to have a chronic disease or develop one in the near future. To do this, the investigators will: * Use information from earlier research studies and experts to pinpoint which patient information (for example, certain blood tests) would be most useful to spot people with chronic conditions. * Extract relevant information from historical patient records, looking at who has these risk factors and which patients developed chronic conditions. The investigators will use information from hospital and general practitioner records. * Build tools to combine this information to predict which people have, or will develop, chronic conditions. * Implement these tools into a "real-time" digital platform that could be used to find which people should undergo further testing for a chronic condition. * Test the platform usability with clinical stake holders.

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.

Left Bundle Branch Area Pacing (LBBAP) PMCF Study

The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.

Digital diagnoSis of Cardiac sOUNd in peDiatric Patients [DI-SOUND Study]

Neonatal screening procedures for potentially life-threatening congenital cardiovascular diseases (i.e., duct-dependent systemic or pulmonary circulation), currently implemented at the national level, rely primarily on cardiovascular physical examination performed by a neonatologist. More recently, this approach has been complemented by the assessment of hemoglobin oxygen saturation at both the upper and lower extremities (pre- and post-ductal saturation) in order to improve diagnostic sensitivity, although this practice has not yet been uniformly adopted nationwide. Converging evidence indicates that these screening strategies are affected by significant limitations in both sensitivity (failure to identify affected individuals) and specificity (false-positive findings in healthy subjects). These limitations are associated with substantial overall costs for the healthcare system. Failure to correctly identify affected neonates may result in increased morbidity and mortality, whereas overdiagnosis leads to unnecessary second-level diagnostic investigations and imposes a considerable psychological burden on families, who remain understandably anxious until diagnostic confirmation is achieved. The aim of the present research project (proof-of-concept study) is to develop a digital classifier capable to categorize heart sounds with commercially available digital stethoscopes into a binary classification system distinguishing physiological from pathological sounds. The derivation phase will be followed by a prospective validation phase, in which the classifier will be applied to assess its diagnostic performance. This phase will also evaluate the economic impact of the digital screening approach compared with standard practice. During the derivation phase, neonates with known cardiovascular status, as determined by prior echocardiographic assessment (including both healthy subjects and those with congenital heart disease), will be enrolled. Heart sounds will be recorded in a quiet environment under standard clinical conditions, without sedation. Digital recordings will be stored in WAV format and analyzed to develop a binary classification algorithm capable of distinguishing healthy from pathological cases. Following development, the classifier will be prospectively applied to a validation cohort of neonates undergoing conventional cardiovascular screening (clinical examination and pre- and post-ductal pulse oximetry), followed by classification using the digital tool under investigation. All participants will subsequently undergo confirmatory echocardiography. Diagnostic performance metrics, including sensitivity, specificity, positive and negative predictive values, and likelihood ratios, will be calculated for both the digital and conventional screening modalities. Furthermore, the number of missed pathological cases and the number of unnecessary second-level investigations resulting from false-positive findings will be used to define the economic benefit profile of the proposed screening strategy. Monte Carlo simulation techniques will be employed to extrapolate these findings at the national level, using ISTAT data on birth rates and disease prevalence. It is anticipated that the development of a digital classifier for the binary classification of neonatal heart sounds will be feasible. Moreover, it is expected that this tool will demonstrate superior diagnostic performance compared with current neonatal screening strategies, with beneficial implications not only for the accurate identification of affected and healthy neonates but also for reducing overall healthcare costs associated with missed diagnoses and inappropriate overdiagnosis.

Efferon LPS Hemoadsorption in Cardiac Surgery Patients

This randomized controlled study aims to evaluate the efficacy and safety of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the postoperative period. Each patient in the treatment group will undergo two hemoadsorption sessions: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours.

ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.

Health App Data Collection Study

Utilization of additional wearable data to improve clinical outcome

Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay

MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression. In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression. Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states.

Cardiac Clearance vs G60 Hip Frailty Index

The primary objective of this study is to establish a data repository that will be permissive of quality improvement studies/observations specific to postoperative mortality outcomes for geriatric patients with orthopedic injuries based on Orthopedic Hip Frailty Score and preoperative cardiac clearance predictors.

Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery

Coagulopathic-induced bleeding after cardiopulmonary bypass in cardiac surgery patients is common and is associated with adverse outcomes in cardiac surgery. The hypothesis of the study is that FEIBA will be a more effective treatment than standard of care (FFP) in cardiac surgery patients who have coagulopathic-induced bleeding. This study is being conducted to determine the efficacy of FEIBA versus FFP as first line therapy in correcting coagulopathic induced microvascular bleeding in cardiac surgery patients.

Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study

Single center, open-label, phase IV clinical trial to study the application of radiomics in molecular imaging for diagnosis and follow-up of CVDIs. The study will include three populations: * Retrospective cohort (2018-2025) * Prospective cohort (2026-2027) * Control group (prospective)

Heparin vs Placebo for Cardiac Catheterization

Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.

Ask Questions About Clinical Trials

The overall goal of this study is to assess the implementation of the Ask Questions about Clinical Trials (ASQ-CT) brochure, a patient-focused communication tool previously demonstrated to improve patient-provider communication about clinical trials. Participants will be given the ASQ-CT brochure at Time 1 (baseline) and participants will complete a questionnaire at three timepoints, baseline (Time 1), Pre-Research Visit (Time 2), and Post-Research Visit (Time 3).

Cardiovascular Structure and Function in the Mucopolysaccharidoses

This study's investigators previously demonstrated the potential utility of non-invasive carotid ultrasonography to calculate carotid intima media thickness (cIMT) and stiffness (as measured by the three parameters, carotid cross-sectional distensibility \[cCSD\], carotid cross-sectional compliance \[cCSC\], and carotid incremental elastic modulus \[cIEM\]) in people with mucopolysaccharidoses (MPS). Investigators also studied arterial gene expression in animal models of MPS, and identified upregulation of a number of markers potentially tied to atherosclerosis and inflammation. These include the atherosclerotic marker known as Clusterin (CLU), Cathepsin S, Elastin, and the inflammatory cytokines interleukin 1-α, interleukin 1-β, interleukin 2, and interleukin 6. Other studies have identified elevation in circulating tumor necrosis factor-α correlating with pain and physical disability in certain mucopolysaccharidoses. Since these studies are cross sectional, and not longitudinal, this study aims to annually measure these previously studied biomarkers (carotid measurements, circulating cytokines, cathepsin S, elastin, and CLU) in a large cohort of MPS patients. This study is a 3-year, prospective, anonymized, longitudinal assessment of cardiovascular structure, function, and circulating biomarkers in patients with mucopolysaccharidoses.

One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG

The use of a graft from the left internal thoracic artery to the left anterior descending artery has become the gold standard for the indication of coronary artery bypass grafting. However, choosing a graft for the second-best coronary artery, focusing on long-term patency, is still a challenge. The saphenous vein using the "no-touch" technique is an alternative to a radial artery graft, but there is little evidence, especially in women. This randomized clinical study aims to compare the patency of these grafts in the second-best coronary artery in women undergoing coronary artery bypass grafting.

The Clinical Value of Deep Learning-Based Reconstruction Techniques in Cardiac MRI Scanning

By enrolling patients who underwent cardiac MR(Magnetic Resonance) examinations at our center and using randomized allocation, the patients were divided into a study group and a control group. The study group underwent scanning using AI-based(Artificial Intelligence-based) cardiac MRI(Magnetic Resonance Imaging) sequences, while the control group was scanned using non-AI cardiac MRI sequences

Cardiometabolic Disease Risk Factors in Cameroon

Cardiometabolic diseases (CMDs) are a major public health concern in sub-Saharan Africa, including Cameroon. Studies have shown a significant increase in the prevalence of hypertension, diabetes, and obesity in recent years. However, access to timely diagnosis and treatment remains limited, particularly in rural areas. Community-based screening programs have been shown to be effective in identifying individuals with undiagnosed CMD risk factors and promoting early intervention. By leveraging the strengths of community-based approaches, the URBACAM-D study aims to address the growing burden of CMDs in urban Cameroon.

Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery

All patients will be completed collection of demographic data, clinical data, and be observed for inflammatory organ damage, oxygenation index or SpO2/ FIO2, WBC, NEU, interleukin-1β, interleukin-6, interleukin-8 (IL-1β/6/8), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), procalcitonin (PCT), myoglobin (Myo), creatine kinase-MB (CK-MB), high-sensitivity cardiac troponin T (hs-cTnT), neutrophil elastase (NE), myeloperoxidase (MPO), APACHE II score, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, Murray lung injury score, serum creatinine, eGFR, mechanical ventilation time, ICU length of stay, drug-related gastrointestinal reactions, and 30-day and 90-day all-cause mortality, among other indicators.

Opportunistic PK/PD Trial in Critically Ill Children (OPTIC)

OPTIC is a prospective, open-label, non-randomized study of multiple medications administered to approximately 2000 children in the pediatric cardiac intensive care unit (PCICU) per routine clinical car by their treating provider. The purpose of this study is to characterize the PK of drugs routinely administered to children per standard of care using opportunistic and scavenged samples. The prescribing of drugs to children will not be part of this protocol. After the child/adult (\<21 years of age) is consented/enrolled, demographic and clinical data will be extracted from the EHR. Biospecimen information (including date and time of sample collection) will be collected. Data analysis will be conducted on all participants with at least 2 evaluable samples. The protocol represents minimal risk to the children/adults who provide body fluid for this study, including potential loss of confidentiality (samples will be assigned a unique accession number) and risks associated with blood draws. Adverse Events (AEs)/Serious Adverse Events (SAEs) caused by the study specimen collections will be monitored and recorded in the Electronic Data Capture (EDC) system.

The Heart Outcomes in Pregnancy Expectations (H.O.P.E) Registry

Prospective US registry of pregnant women with cardiac disease to address the substantial gaps in knowledge surrounding these patients, in order to improve future care.

Rectus Sheath Block in Cardiac Surgery

This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block. 1. Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery? 2. Does the rectus sheath block decrease VAS pain scores postoperatively after cardiac surgery? Study participants will be assigned to receive either rectus sheath block or no block.

Implementation of New Exercise Protocols in Cardiac Rehabilitation.

* Primary Objective: To evaluate the effects of complementary exercise protocols in cardiac rehabilitation (CR), such as inspiratory muscle training (IMT), by assessing inspiratory muscle strength. * Secondary Objectives: To assess functional capacity, quality of life (QoL), and pulmonary function.

Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis

REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.

Quality of Cardiopulmonary Resuscitation Pre- and Intra Hospital

The survival after intrahospital cardiac arrest has been reported to 15%. In Norway this varies between 16 and 23%.). Many factors are associated with survival after cardiac arrest, both intra- and prehospital. Recent studies have not included information about individual patient factors and the outcome after cardiopulmonary resuscitation (CPR). In the current hospital, we are able to record patient specific information related to a cardiac arrest/CPR situation, and thereby be able to assess patient-related factors associated with both detection, treatment and outcome of CPR.