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NCT ID: NCT04764305 Recruiting - Liver Diseases Clinical Trials

Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient a Metabolomics and Proteomics Approach

Start date: April 1, 2022
Phase:
Study type: Observational

Out objective is to identify the mechanisms that promote hepatic and myocardial fibrosis, and collateral vessel formation in patients with complex congenital heart disease and Fontan circulation.

NCT ID: NCT04763291 Recruiting - Clinical trials for Cardiovascular Diseases

Cardiovascular and InflammAging Study

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Evidence from previous studies supports a strong relationship between fruit and vegetable consumption and reduced cardiac risk. This could be mediated via improvements on blood pressure, platelet function and vascular reactivity. Certain vitamins and polyphenols found in fruits and vegetables, have antioxidant and anti-inflammatory effects and play a major role on the function of immune cells. Previous studies have also demonstrated the importance of omega-3 fatty acids on humans' health and their positive effects on the cardiovascular system and blood lipids regulation, as well as their involvement on inflammatory response. Nutritional regimens with adequate intake of micronutrients, fruit and vegetables, omega-3 fatty acids, low in sugar and saturated fats, such as the Mediterranean diet or vegetarian diets, can reduce chronic inflammation and oxidative stress and improve cardiovascular risk profile. Considering that the population's fruit and vegetable and omega-3 intakes are below recommendations, whole food-based supplements could provide an accessible form of supplementation to bridge the gap between actual and recommended intakes. This study is aiming to assess whether long-term separate ingestions of an encapsulated juice powder concentrate and a plant-based omega fatty acid supplement, or a combined ingestion of the two, can affect biomarkers of cardiovascular health, low-grade inflammation and indicators of biological aging in older adults.

NCT ID: NCT04761068 Recruiting - Clinical trials for Coronary Artery Disease

Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts

Start date: December 15, 2017
Phase:
Study type: Observational [Patient Registry]

This is a prospective, investigator-initiated, multi-center, open label and post-market registry, enrolling patients with atherosclerotic coronary artery disease, scheduled for CABG with at least one SVG bypass. The registry is designed to evaluate the clinical outcome of CABG surgery with an external support device (VEST) for SVG bypasses. In each patient, use of the VEST will be according to its approved indications for use and attempt will be made (based on clinical judgement) to support each non-sequential SVG bypass graft with a VEST device. Subjects will be followed for 5 years, with interim follow ups at 12 and 24 months. MACCE and EQ5D3L will be documented at every follow up visit.

NCT ID: NCT04754217 Recruiting - Clinical trials for Aortic Valve Disease

Valved Graft PMCF Study

Start date: July 13, 2021
Phase:
Study type: Observational

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

NCT ID: NCT04753307 Recruiting - Inflammation Clinical Trials

Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery

INSIGHT
Start date: January 19, 2021
Phase:
Study type: Observational

Postoperative cardiovascular complications are common after noncardiac surgery. The association between perioperative inflammation and the occurrence of cardiovascular complications after surgery is still unknown. Therefore, we will evaluate as our primary aim the association between patients with increased postoperative inflammation, assessed with C-reactive protein measurements, and the occurrence of major cardiovascular complications after noncardiac surgery. We will further evaluate the influence of perioperative inflammation on the occurrence of postoperative acute kidney injury. We will also evaluate the association between inflammation and the influence on Days-At-Home within 30 days. Furthermore, we will evaluate the association between increased inflammatory biomarkers and postoperative N-terminal pro brain natriuretic peptide (NT-proBNP) concentration.

NCT ID: NCT04751357 Recruiting - Clinical trials for Heparin-induced Thrombocytopenia

Argatroban Monitoring in Critically Ill Patients: Evaluation of a Novel Ecarin-based Bedside Test

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

Argatroban is a parenteral direct Thrombininhibitor used for anticoagulation in patients suffering from heparin induced thrombocytopenia (HIT). There is increasing evidence suggesting that the activated partial thromboplastine time (aPTT), which is recommended for dosage monitoring, correlates poorly with serum argatroban concentration in critically ill patients. Therefore it may be badly suited to determine the correct dosing. Ecarin based tests have been proven to be effective in determining effects of direct thrombin inhibitors. The investigators now plan to evaluate a novel, rotational thrombelastometric, ecarin based bedside test for its ability to measure the effect of argatroban in critically ill patients. So far an excellent correlation of a similar test could be shown in spiked plasma of healthy adults. According to the manufacturer the ECA-Test is able to detect direct thrombininhibitors. However to our knowledge neither the ECA-Test nor other ecarin-based thrombelastometric tests have been studied in critically ill patients treated with argatroban. The investigators therefore seek to investigate the correlation of the ECA-Test (ClotPro®) with the serum argatroban concentration.

NCT ID: NCT04750798 Recruiting - Cardiac Arrhythmias Clinical Trials

An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

Start date: February 22, 2021
Phase:
Study type: Observational

The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.

NCT ID: NCT04737369 Recruiting - Clinical trials for Traumatic Brain Injury

Multimodal Neuromonitoring

MMNM
Start date: December 1, 2020
Phase:
Study type: Observational

Theoretical Framework & Background Cortical spreading depressions (CSD) and seizures, are crucial in the development of delayed cerebral ischemia and poor functional outcome in patients suffering from acute brain injuries such as subarachnoid hemorrhage. Multimodal neuromonitoring (MMNM) provides the unique possibility in the sedated and mechanically ventilated patients to record these electrophysiological phenomena and relate them to measures of cerebral ischemia and malperfusion. MMNM combines invasive (e.g. electrocorticography, cerebral microdialysis, brain tissue oxygenation) and noninvasive (e.g. neuroimaging, continuous EEG) techniques. Additionally, cerebral microdialysis can measure the unbound extracellular drug concentrations of sedatives, which potentially inhibit CSD and seizures in various degrees, beyond the blood-brain barrier without further interventions. Hypotheses 1. Online multimodal neuromonitoring can accurately detect changes in neuronal metabolic demand and pathological neuronal bioelectrical changes in highly vulnerable brain tissue. 2. Online multimodal neuromonitoring can accurately detect the impact of pathological neuronal bioelectrical changes on metabolic demand in highly vulnerable brain tissue. 3. The occurrence and duration of pathological neuronal bioelectrical changes are dependent on sedatives and antiepileptic drug concentrations 4. The occurrence and duration of pathological neuronal bioelectrical changes have a negative impact on functional and neurological long-term patient outcome. 5. Simultaneous invasive and non-invasive multimodal neuromonitoring can identify a clear relationship of both methods regarding pathological neuronal bioelectrical changes and metabolic brain status. Methods Systematic analysis of MMNM measurements following standardized criteria and correlation of electrophysiological phenomena with cerebral metabolic changes in all included patients. In a second step neuroimaging, cerebral extracellular sedative drug concentrations and neurological functional outcome, will be correlated with both electrophysiologic and metabolic changes. Due to numerous high-resolution parameters, machine learning algorithms will be used to correlate comprehensive data on group and individual levels following a holistic approach. Level of originality Extensive, cutting edge diagnostic methods are used to get a better insight into the pathophysiology of electrophysiological and metabolic changes during the development of secondary brain damage. Due to the immense amount of high-resolution data, a computer-assisted evaluation will be applied to identify relationships in the development of secondary brain injury. For the first time systematic testing of several drug concentrations beyond the blood-brain barrier will be performed. With these combined methods, we will be able to develop new cerebroprotective treatment concepts on an individual basis.

NCT ID: NCT04735666 Recruiting - Clinical trials for CIED Related Infection

European TauroPace Registry - University of Schleswig-Holstein Prospective Observational Clinical Study

ETPR
Start date: February 22, 2021
Phase:
Study type: Observational [Patient Registry]

University of Schleswig-Holstein Campus Kiel is sponsoring the European TauroPace Registry. This investigator-initiated local, prospective, non-interventional, multi-center study includes patients undergoing cardiac implantable electronic placement including and not limited to placement, revision with the aim to upgrade or downgrade, generator substitution, additional lead placement, revision or extraction (procedure) with adjunct TauroPace. It is planned to include a total of at least 2300 procedures (valid for safety analysis).

NCT ID: NCT04733430 Recruiting - Lung Cancer Clinical Trials

LALUCA Research Platform A Prospective Analysis of Lung Cancer Diagnosis and Management in Clinical Practice

LALUCA
Start date: April 17, 2020
Phase:
Study type: Observational [Patient Registry]

This is a prospective analysis of the diagnosis and treatment of lung cancer in a real-world setting. The aim of the project is to establish a clinical platform to collect representative data on molecular testing, sequence of systemic tumor therapy and other therapies, and disease progression of patients with lung cancer. A special focus will be on molecular biomarker testing and reflex NGS testing. Another aim of the registry is the collection of quality indicators in lung cancer care. The results of the register will be used to describe the current state of care and to develop it further for the future.