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Cardiac clinical trials

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NCT ID: NCT06453161 Completed - Surgery Clinical Trials

Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery: a Retrospective Monocentric Cohort Study

SGLT2i
Start date: April 1, 2024
Phase:
Study type: Observational

Cardiac surgery with cardiopulmonary bypass exposes patients to the risk of post-operative acute kidney injury. In the specific setting of cardiac surgery, acute kidney injury is often of multifactorial origindue to particular haemodynamic mechanisms, renal hypoxia, or damage linked in the inflammatory reaction or haemolysis (1). In recent years, inhibitors of the sodium/glucose co-transporter type 2 (SGLT2i) have demonstrated their relevance in reducing the morbidity and mortality associated with chronic or acute heart failure and chronic kidney disease. These drugs were initially developed to optimise glycaemic control in diabetic patients. They are currently recommended as part of the management of diabetic patients at high cardiovascular risk, patients with systolic and/or diastolic heart failure, and patients with chronic kidney disease. Some pharmacodynamic properties of SGLT2i suggest that they could have a beneficial effect in preventing the onset of acute kidney injury, but also that they could lead to potentially deleterious effects in renal haemodynamic in specific situations. The aim of the study was to estimate the impact of pre-operative exposure to SGLT2i on the occurrence of post-operative acute kidney injury in high-risk renal patients undergoing cardiac surgery.

NCT ID: NCT05297877 Recruiting - Cardiac Clinical Trials

Use of Artificial Intelligence Cardiac Ultrasound Technology in Teaching Point of Care Cardiac Ultrasound

Start date: January 14, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the effectiveness of artificial intelligence (A.I.) cardiac ultrasound technology in teaching point of care cardiac ultrasound (POCUS Cardiac).

NCT ID: NCT05084391 Withdrawn - Cardiac Arrhythmia Clinical Trials

Phase I/II Randomized Study of Stereotactic Ablative Radiotherapy (SABR) Versus Standard of Care for Refractory Structural Cardiac Arrhythmias (SABR-HEART)

Start date: September 12, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I: For the Phase I portion, there will be up to 15 patients treated with SABR and followed for 6 months post-treatment to ensure no significant acute grade 3 or 4 toxicity from SABR treatment. Efficacy as defined below will also be assessed. Following this Phase I lead-in, results will be presented to the FDA for review. Only upon favorable analysis by the FDA committee, and with written explicit permission, will the Phase II randomized portion ensue. This is to act as a safety and efficacy safeguard and has is addressed more thoroughly in the Statistical Analysis Plan of this protocol. Phase II: A 1:1 randomized Phase II portion with 25 patients in each arm assigned to SABR or current practice (standard of care; Figure 3). Standard of care is defined as nationally recognized appropriate next treatment strategies for medical and catheter-ablation refractory structural cardiac VT that is assessed and judged appropriate for the patient by his/her treating cardiologist. This includes repeat catheter ablation (intravascular and/or epicardial catheter ablation), placement of left-ventricular assist device (LVAD), heart transplant, or further medical management (e.g. antiarrhythmic drug modulation/continuation). Randomization will be performed through the Clinical Trial Conduct (CTC) website.

NCT ID: NCT04585568 Completed - Hemodynamics Clinical Trials

Validation of Ballistocardiographic Biosensors and Other Hemodynamic Measures for Healthy Subjects

Start date: September 28, 2020
Phase:
Study type: Observational

Ballistocardiographic (BCG) biosensors reflecting the patients' current state is established. There are few studies documenting BCG biosensors efficacy, effectiveness, and efficiency. In addition, technologies using invasive blood pressure curves and Near Infrared Regional Spectrometry (NIRS) to measure hemodynamics have been used. Using these technologies to guide clinical decisions may be an major advance for patients with acute and chronic diseases. The investigators will explore how these technologies compares to well established technologies measuring vital signs of healthy subjects. The investigators will use live continuous and non-continuous biosensor data to monitor the development of vital parameters during different scenarios. The study will document how CPD measured by biosensors, cerebral oximetry measured by NIRS, and invasive blood pressure curves measured by FloTracâ„¢ are compared to established technologies of vital organ functionality. Data will be measured continuously and documented simultanuously with technologies such as Doppler Echocardiography, transthoracic impedance (TTI), Electrocardiogram (ECG), invasive blood pressure [cardiac output/index (CO/CI), stroke volume/stroke volume index (SV/SVI), stroke volume variation/pulse pressure variation (SVV/PPV), systemic vascular resistance/ systemic vascular resistance index (SVR/SVRI), mean arterial pressure (MAP)], pulse oximetry (SpO2) and cerebral oximetry (rSO2). Of special interest is to document how relative heart stroke volume reflects blood flow documented by the parallel technology measures. All these measures are the key part in the study to document user friendliness, accuracy, sensitivity, specificity and correlations. The main research question is whether adding BCG biosensor measures, cerebral oximetry and invasive blood pressure to monitor vital signs will add meaningful information to the care of patients in a situation where we are able to control all the factors that may impact these measures. The aim of the study is to document (correlation, sensitivity and specificity) how BCG biosensors perform compared to each other and to well established technologies used for monitoring blood flow, blood pressure, heart rate and respiration rate in steady state and during ambulance transport. In addition, the investigators will in a controlled manner measure how established maneuvers like Trendelenburg, hypo-/hyperventilation, and bolus of fluid influences our measures.

NCT ID: NCT04096781 Completed - Stroke Clinical Trials

Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention

ENHANCE-AF
Start date: December 18, 2019
Phase: N/A
Study type: Interventional

A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention

NCT ID: NCT04024982 Completed - Cardiac Clinical Trials

TEE Training for Anaesthesiologists

Start date: February 22, 2018
Phase: N/A
Study type: Interventional

This study aims to find out the best sequence of teaching and learning events (i.e. first lecture and then simulated training or first simulated training and then lecture) in the acquisition of knowledge on Transoesophageal Echocardiography among trainee and specialist anaesthesiologists.

NCT ID: NCT03047876 Not yet recruiting - Infants Clinical Trials

Brain Vascular Reactivity to Hypothermic Circulatory Arrest With Antegrade Cerebral Perfusion During Aortic Arch Surgery

Start date: March 1, 2020
Phase:
Study type: Observational

Many neonates and infants who undergo complex cardiac surgery are affected by neurological developmental delays. Whilst catastrophic events are immediately identifiable from clinical examination or by macro changes on MRI or CT scans, smaller changes are often not immediately visible or detected. This is an observational pilot study examining brain vascular reaction to hypothermic circulatory arrest with antegrade cerebral perfusion and neuro-protection techniques during aortic arch surgery in neonates and infants. A combination of duplex ultrasound and transcranial doppler will be used to record in-depth information on the cerebrovascular changes that occur during the entire length of the surgical procedure and during the early postoperative period. The proposed techniques and equipment are non-invasive and are in use clinically to evaluate brain perfusion in a similar age group. During aortic arch surgery, the patient's body and brain temperature is reduced to values between 18 and 24 degrees centigrade in order to decrease metabolic demand that provides a form of metabolic protection. However, there is no consensus within the clinical community regarding the optimal temperature at which to perform surgery. Moreover, in order to improve cerebral perfusion, the brain is perfused via the right internal carotid artery with cold blood. At Alder Hey Children Hospital, this surgery is undertaken by the three surgeons but, due to clinical preference, differs in relation to the temperature at which surgery is undertaken. This provides the opportunity to observe the impact of different temperatures on cerebral vascular reactivity in neonates and young infants The arguments for future comparisons and a larger randomised study will be made based on the information gained from this observational study.

NCT ID: NCT02798068 Recruiting - Cardiac Clinical Trials

Steroids and Microcirculation In Cardiac Surgery

SICS
Start date: May 2016
Phase: Phase 4
Study type: Interventional

Cardiac surgery is sometimes associated with organ dysfunction of variable severity (renal insufficiency, cognitive decline, arrhythmias, ARDS). The phenomenon responsible is an intense inflammatory reaction induced by cardiopulmonary bypass, leading to microcirculation alterations, specially in endothelial cell and its protective layer - glycocalyx. Endothelial dysfunction then reduces the reactivity of peripheral tissues to hypoxia, and is associated with bad prognosis. High - dose corticoids administration at anesthesia induction in cardiac surgery could attenuate the intensity of this inflammatory reaction, and represents the current practice in our hospital. Nevertheless, this attitude is abandoned in numerous cardiac surgery centres.

NCT ID: NCT01598766 Recruiting - Cardiac Clinical Trials

General Investigative MRI Protocol

Start date: May 2012
Phase: Phase 1
Study type: Interventional

This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software being evaluated. If they agree, they can receive their MRI exam with the new coil, sequence or software instead of the standard one.

NCT ID: NCT00639704 Completed - Cardiac Clinical Trials

Improve Nuclear Medicine Heart Imaging, Compare MRI Results With Single Photon Emission Computed Tomography Imaging

Start date: January 1996
Phase:
Study type: Observational

The purpose of this study is to compare the MRI results with the new SPECT image reconstruction method, this study will allow us to determine whether a new more accurate method of looking at the heart by nuclear study can be used in routine clinical use.