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NCT ID: NCT06043180 Not yet recruiting - Clinical trials for Aortic Stenosis, Severe

Outcome Prediction in Patients With Aortic Stenosis After TAVI

PREDICT-TAVI
Start date: October 1, 2023
Phase:
Study type: Observational

This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation

NCT ID: NCT06042907 Recruiting - Contracture Clinical Trials

Development, Validation, and Evaluation of a Risk Assessment Tool for Contractures: the ORACLE Study

Start date: September 11, 2023
Phase:
Study type: Observational

The Observational Risk Assessment for Contractures- Longitudinal Evaluation (ORACLE) is a risk assessment tool for contractures. The tool was originally designed and developed by a group of multidisciplinary health professionals within Dorset Healthcare University NHS Foundation Trust (DHUFT). Bournemouth University and DHUFT sponsored a match funded studentship to establish the academic validation of the tool. The results from the previously conducted studies (Phase One) as part of this project: (i) a systematic review of the literature and an (ii) online Delphi survey with field experts provided initial evidence for further development, content validity, and modification of the tool. The current study (Phase Two) aims to establish the psychometric validation, acceptability, and usability of the modified tool through formal testing on adult care home residents in Dorset. It consists of two streams of work: Stream A aims to establish the psychometric validation by completing the ORACLE assessments on adult care home residents. The assessments will be performed by the care home staff. In Stream B, a realist evaluation will be performed to explore the usability and practicality of ORACLE with selected care home managers and staff who were involved in organising and completing the assessments on ORACLE respectively. The results from this two-phase design will then inform further revisions of the tool if required.

NCT ID: NCT06042673 Recruiting - Clinical trials for Postmenopausal Women

Impact of Pomegranate Seed Oil on Postprandial Cardiovascular Disease Risk Markers

Start date: July 6, 2023
Phase: N/A
Study type: Interventional

Dietary fat plays a crucial role as a modifiable risk factor influencing both non-fasting lipaemia and vascular reactivity. Notably, the intake of dietary saturated fatty acids (SFAs) has been associated with adverse effects on blood lipid profiles, whereas increased consumption of unsaturated fatty acids (UFAs) has shown potential to improve lipid health. Pomegranate seed oil (PSO) stands out due to its high content of conjugated α-linolenic acids (CLnAs). However, research comparing the impact of these fatty acids on postprandial vascular function, particularly in postmenopausal women, remains limited. A cross-over, single-blind, randomised acute postprandial study will be conducted in 15 healthy postmenopausal women. Participants will be assigned to consume the test meals either a placebo (50 g of mixed fat; 4:0.5:0.5 palm oil: rapeseed oil: safflower oil) or PSO (40 g of mixed fat and 10g of PSO) in random order on 2 separate occasions, with 4-6 weeks between each study visit. The anthropometric, blood pressure, and arterial stiffness, will be taken for each study visit. Blood samples will be collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers, and whole blood culture. The findings from this study will contribute to the evidence base on how consuming meals rich in PSO influence the level of blood lipids as well as other biomarkers for cardiovascular disease.

NCT ID: NCT06042231 Recruiting - Atrial Fibrillation Clinical Trials

Impact of Cardiac Prehabilitation, REhabilitation and Patient EDucation on Outcomes in Patients Undergoing First-time AF Ablation

CREED AF
Start date: November 2, 2023
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is a term used to describe an irregular, and often very rapid, heartbeat. AF increases the risk of a number of diseases associated with the heart and cardiovascular system. Ablation is a procedure to treat AF. It uses small burns or freezes to cause some scarring on the inside of the heart to help break up the electrical signals that cause irregular heartbeats. This can help the heart maintain a normal rhythm. Currently patients who are referred for AF ablation do not receive any additional support as part of standard care to improve the outcomes of their ablation procedure. Whereas cardiac rehabilitation is a recognised part of comprehensive care for coronary heart disease patients (patients whose hearts struggle to receive blood), with exercise and education consistently identified as central elements to their rehabilitation. This treatment is not yet recommended for AF ablation patients. Therefore, the CREED AF Study is investigating whether a tailored comprehensive exercise and education intervention can improve outcomes in patients who are undergoing first time AF ablation. Central to the CREED AF study is the 'prehabilitation' intervention, whereby exercise and education training will be conducted before AND after AF ablation. 106 participants is the target recruitment, they will be randomised to either receive the CREED AF intervention (exercise and education intervention before AND after AF ablation) or a standard care (control) group. The standard care group will receive a one off 1-to-1 patient education session with a trained practitioner before their AF ablation procedure. This research study does not affect the AF ablation procedure that patients will have as part of their standard of care.

NCT ID: NCT06042023 Recruiting - Surgery Clinical Trials

Remote Patient Monitoring for Preoperative Risk Assessment

REMOTES
Start date: December 19, 2022
Phase: N/A
Study type: Interventional

Preoperative risk assessment (an evaluation of overall health before surgery) is important to determine the overall risk of mortality and complications for patients undergoing major abdominal surgery to allow the appropriate allocation of sparse hospital resources. The current gold standard for preoperative assessment is cardiopulmonary exercise testing (CPET). CPET is, however, not available in all centres that perform major surgery, it is a costly test, and therefore only high-risk patients are tested. Finding new ways of conducting preoperative assessment could improve overall surgical safety, patient experience and reduce cost. The preoperative use of remote vital signs monitoring can provide important information about the patients' fitness and overall health and may be used for preoperative assessment. This study will use a remote monitoring patch to monitor patients' vital signs before surgery. The aim is to evaluate the utility and patient acceptability of the remote monitoring system and the feasibility of a randomised controlled trial of this type of assessment. Additionally, the study will assess the correlation between the data captured by the remote monitoring system and the CPET results to evaluate the remote monitoring system's ability to predict risk of surgery. The study will take place in Leeds Teaching hospitals. Adult patients undergoing major abdominal surgery that require CPET before surgery are eligible. Participants will be monitored at home with the patch monitor for 3-5 days before surgery, in addition to their planned preoperative assessment. During remote monitoring, patients will be asked to complete questionnaires on their general health and experience using the patch paired with the mobile phone as part of the monitoring system. Clinical data from the electronic hospital records and general practitioner records available on the trust system will then be collected after surgery to assess complications and calculate risk scores.

NCT ID: NCT06041906 Enrolling by invitation - Clinical trials for Congenital Porto-Systemic Shunt (CPSS)

International Registry of Congenital Portosystemic Shunt (IRCPSS)

IRCPSS
Start date: April 26, 2018
Phase:
Study type: Observational [Patient Registry]

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

NCT ID: NCT06041841 Not yet recruiting - Clinical trials for PCSK1 Deficiency Obesity

A Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Genetic Obesity

Start date: December 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity

NCT ID: NCT06040658 Recruiting - Surgery Clinical Trials

Frailty Assessment in Vascular Hot Clinic Setting - Feasibility and Prognostic Value

FAVOUR
Start date: March 15, 2023
Phase:
Study type: Observational

A single-centre prospective study of feasibility assessing the suitability of introducing routine frailty screening in a controlled, and reproducible, outpatient department setting for Vascular Surgery patients. This study will also perform head-to-head comparisons of the prognostic value of five frailty assessment tools, selected based on the previous demonstration of their popularity and familiarity within the speciality, their designs being based on different theories of frailty and that some are endorsed by local healthcare police. Inter-user variability (patient self assessment and clinician assessment will also be compared).

NCT ID: NCT06040528 Recruiting - Clinical trials for Myocardial Infarction

Early Discharge Pathway Registry

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading causes of mortality worldwide. With advances in technology and our understanding of cardiac disease, we can now treat CAD using minimally invasive interventional techniques. This has revolutionised treatment for and improved the lives of many patients with CAD. Although trials have assessed various therapeutic strategies in various populations, real-world evidence of intervention and medical treatment among patients with CAD is increasingly recognised as an important part of providing safety and efficacy data and improving the care we provide. Regional heart attack services have improved clinical outcomes following ST-segment elevation myocardial infarction (STEMI) by facilitating early reperfusion by primary percutaneous coronary intervention (PCI). Early discharge after primary PCI is welcomed by patients and increases the efficiency of health care. This data will add to that literature by assessing the characteristics and outcomes of patients with CAD, concentrating on those who are discharged via the early discharge pathway. It will also identify and characterise predictors of outcomes, and improve risk stratification and diagnostic evaluation.

NCT ID: NCT06040086 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

MIRANDA
Start date: September 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.