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Cardiac Disease clinical trials

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NCT ID: NCT06027164 Active, not recruiting - Cardiac Disease Clinical Trials

Kosmos Trio and Ejection Fraction Pivotal Study

Start date: August 4, 2023
Phase:
Study type: Observational

This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Image quality between novices and experts as well as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in post-hoc Echo image analysis

NCT ID: NCT06019546 Recruiting - Acute Kidney Injury Clinical Trials

PErfusion QUality ODds

PEQUOD
Start date: January 23, 2023
Phase:
Study type: Observational

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a frequent complication after cardiac operations with cardiopulmonary bypass (CPB) use. Its frequency varies depending on the severity grade. There are different "static" predictive scores for the CSA-AKI based on the patient and surgery-associated parameters. Recently, in our Institution was developed a predictive algorithm for CSA-AKI that starts with a static model and then integrated with 7 CPB-associated parameters: HCT, DO2, time of exposure to a critical DO2, systemic pressure, CPB duration time, lactate value, transfusion of red blood cells (RBC), that together build a dynamic perfusion risk (DPR) associated to the CPB. Combining the static and dynamic models produces the Multifactorial Dynamic Perfusion Index (MDPI). The present study validates MDPI in a new prospective series of patients undergoing cardiac surgery with CPB.

NCT ID: NCT06008821 Recruiting - Cardiac Disease Clinical Trials

Paravertebral Block for Improvement of Quality of Recovery Following Cardiac Surgery

Start date: October 13, 2023
Phase: N/A
Study type: Interventional

This study aims to evaluate the efficacy of bilateral, paravertebral blockade (intervention) against sham blocks (control) placed prior to sternotomy in improving quality of recovery following cardiac surgery. Primary outcome: The hypothesis is that bilateral single-shot PVB at the thoracic spinal segmental levels T3/4, compared with sham blocks, improve the Quality of Recovery-15 (QoR-15) score at 24 hours following cardiac surgery by a minimally clinically important difference of 8.0 or greater. Secondary outcomes: The hypothesis is that the intervention will reduce pain scores, opioid requirements, and related side effects; improve respiratory mechanics; and facilitate a better first night's rest/sleep in the first 24-48 hours compared to sham blocks.

NCT ID: NCT05996640 Not yet recruiting - Cardiac Disease Clinical Trials

Patient Preferences and Experiences of Waiting for Heart Surgery

Start date: August 14, 2023
Phase:
Study type: Observational

Waiting for heart surgery could be difficult and anxiety-provoking for some patients. Research suggests that some specific factors (e.g., individual coping strategies, communication with the clinical team, having a more active role in care decision-making) could reduce the stress associated with waiting. However, most of this research has looked at patients waiting for other types of surgery (e.g., cancer surgery). Therefore, more research focusing on patients waiting for heart surgery is needed. This project aims to investigate patients' experiences, perceptions and preferences about waiting for elective (non-emergency) heart surgery across four London-based National Health Service (NHS) hospitals that belong to King's Health Partners (KHP): Royal Brompton, Harefield, St Thomas', and King's College hospitals. The project is led by the research team at King's Improvement Science, (King's College London), in collaboration with clinicians and patients with lived experience of waiting for heart surgery. This project will look at: - how patients feel their heart condition affects their day-to-day life; - how patients experience being on a waiting list; - what factors patients consider as most important for their upcoming surgery (e.g. to have their surgery as soon as possible, at their nearest hospital, or carried out by a specific surgeon); - patients' opinions about how the heart surgery waiting list process could be improved. Adult patients (>18 years old) waiting for elective heart surgery at the four hospitals listed above will be invited, via a text message and a letter, to complete an online survey (i.e. a list of questions). Completing reading study information and completing the survey will likely take approximately 30 minutes. The survey will be open for 8 weeks in total. Findings from this project, together with other work looking at clinical processes and outcomes across heart surgery services at the four KHP hospitals, will inform a wider quality improvement project.

NCT ID: NCT05996211 Recruiting - Clinical trials for Congenital Heart Disease

The Swiss Neurodevelopmental Outcome Registry for Children With CHD

SwissORCHID
Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

Introduction: Congenital heart disease (CHD) is the most frequent birth defect. As survival has significantly improved, attention has turned to neurodevelopmental outcomes of children undergoing heart surgery in early infancy. Since multiple risk factors contribute to neurodevelopmental alterations, a nationwide registry collecting data on medical characteristics, interventions, clinical course and neurodevelopment until school-age is needed to improve the quality of management, identify risk- and protective factors affecting neurodevelopment, and facilitate multicenter trials. Methods and analysis: The Swiss Outcome Registry for CHIldren with severe congenital heart Disease (ORCHID) is a nationwide, prospective, population-based patient registry developed (1) to collect baseline characteristics and clinical data of CHD patients operated with bypass-surgery or hybrid procedures in the first 6 weeks of life in Switzerland, (2) to monitor long-term neurodevelopment, and (3) to relate clinical characteristics and neurodevelopment to identify risk and protective factors in these children. This registry started data collection relating to pregnancy, birth, preoperative course, catheter-based and surgical treatment, postoperative course and reinterventions in 2019. The primary outcome includes standardised neurodevelopmental assessments at 9 to 12 months, 18 to 24 months and 5.5 to 6 years. Investigators expect to include 80 to 100 children per year. Correlation and regression analyses will be used to investigate risk- and protective factors influencing neurodevelopment. Ethics and dissemination of results: Swiss ORCHID received support by the Accentus Charitable Foundation, the Anna Mueller Grocholoski Foundation, the Swiss Society of Pediatric Cardiology, and the Corelina - Foundation and was approved by the cantonal ethics committees. Findings will be presented at national and international scientific meetings, and published in peer-reviewed journals. Results will also be shared with patient organizations, primary health care providers, and public health stakeholders to ensure a widespread dissemination of the results.

NCT ID: NCT05982041 Not yet recruiting - Cardiac Disease Clinical Trials

Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. The collection of data and biological material will mirror usual clinical practice as far as possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be collected for research purposes to measure a number of biomarkers for the assessment of diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy will be performed at baseline, and a further biopsy offered at 6 months to assess treatment response. A magnetic resonance (MR) muscle protocol will also be performed as per usual clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be repeated at 6-12 months. An existing electronic database entry system will be used for data entry and capture on an anonymised basis.

NCT ID: NCT05957172 Withdrawn - Cardiac Disease Clinical Trials

Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device: Utilization During Cardiac Rehabilitation

MAPS-III
Start date: January 2023
Phase:
Study type: Observational

Advanced remote multi-parameter reporting during cardiac rehabilitation (MAPS-III). The primary purpose of this observational study is to collect baseline information of cardiac rehabilitation usage in the US for post-myocardial infarction (MI) patients with EF > 35% while wearing the ZOLL AMS device for 30 to 60 days. Secondary data on biometrics, arrhythmias, symptoms, and healthcare utilization will provide additional background information on this population during the early post-MI cardiac rehabilitation period.

NCT ID: NCT05942183 Recruiting - Cardiac Disease Clinical Trials

The Relationship Between Optic Nerve Sheath Diameter and Postoperative Delirium in Open Heart Surgery

Start date: August 7, 2023
Phase:
Study type: Observational

Although the incidence of delirium after cardiac surgery is high, it is not sufficiently recognized. The long-term effects of delirium are likely to be underestimated. In this study, the investigators aimed to examine the relationship between optic nerve sheath diameter and postoperative delirium in open hearth surgery.

NCT ID: NCT05880615 Completed - Cardiac Disease Clinical Trials

Opioid Reduced Anesthesia With Parasternal CATheters on Postoperative Delirium After Cardiac Surgery

ORACAT
Start date: May 2, 2022
Phase:
Study type: Observational

PostOperative Delirium (POD) is the most common neuropsychiatric complication following cardiac surgery and may be related to morphine consumption. PostOperative Delirium (POD) prolongs hospital and intensive care unit (ICU) length of stay (LOS) and increases morbidity and mortality. No study has been conducted to demonstrate the effect of regional anesthesia using catheters inserted before sternotomy.

NCT ID: NCT05877755 Not yet recruiting - Cardiac Disease Clinical Trials

Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging

CARDIO-IRM
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) causes at least 1.8 million European deaths annually, exceeding fatalities from cancer, chronic respiratory disease, and diabetes. Consequently, the fight against CVD has become the main priority of the World Health Organization. In the pursuit of understanding and treating CVD, cardiac magnetic resonance imaging (CMR) has remained the only modality capable of providing a comprehensive assessment of the heart's function and structure without harmful radiation. Unfortunately, current CMR systems remain too slow, too complex, require highly trained specialists and, as such, have presented a barrier to a wider adoption of CMR. The aim of CARDIO-IRM is to unleash the full potential of CMR to transform patient trajectories by introducing a fast, one-click, fully automated, and comprehensive imaging pipeline applicable to diagnosis, prognosis, and therapy selection in cardiology.