Clinical Research Directory

Respiratory Muscles and Work of Breathing in Children

Respiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management. The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.

Benefits of no Fasting Compared to Fasting Prior to Elective Cardiac Catheterization: A Single-center Randomized-controlled Trial

More than one million cardiac catheterizations (CCs) are performed annually in the United States and the majority are elective. Current guidelines recommend no fasting prior to elective CC, however recent studies suggest that eating and drinking as desired prior to elective CCs involving moderate sedation is safe. This project will study the potential benefits of allowing patients to eat before elective CCs. Participants will be randomly divided into two groups. One group will receive pre-op instructions to fast, and the other group will be allowed to eat and drink as desired prior to their CC. Researchers will compare these groups with regards to patient satisfaction and respiratory complications.

Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography

This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. The study also aims to investigate the safety and tolerability of NH002.

Health eHeart BioBank

The purpose of the Health eHeart BioBank is to collect and store specimen (e.g. blood, DNA, tissue) for future studies at the University of California, San Francisco (UCSF) that will help determine changes and identify molecular and genetic markers in the human body that might help increase our knowledge of heart disease and guide development of new diagnostic tools and treatments that may help rapidly detect heart disease and prevent and/or treat heart disease.

The Study Aims to Investigate the Frequency and Clinical Characteristics of Out-of-hospital Cardiac Arrests (OHCA) Occurring in Poland in 2023. This Research Seeks to Provide a Comprehensive Analysis of OHCA Incidents Across the Country, Focusing on Their Prevalence and the Associated Clinical fe

1. Objective According to the 2021 European Resuscitation Council (ERC) Guidelines, sudden cardiac arrest is the third leading cause of death in Europe. Accurate and reliable data on the epidemiology of sudden cardiac arrest are essential for better understanding its causes and for analyzing treatment outcomes. Currently, comprehensive statistics on cardiac arrest in Poland are unavailable, resulting in limited knowledge about the scale of this medical issue. This study aims to examine the frequency and clinical characteristics of out-of-hospital cardiac arrests occurring nationwide in 2023. 2. Materials and Methods The analysis will include Emergency Medical Activity Cards from the year 2023. Data for the study will be obtained from the National Center for Monitoring Emergency Medical Services via the Department of Emergency Medical Services of the Polish Ministry of Health and from the Polish Medical Air Rescue. Data will be anonymized by data administrators before being provided to the research team. The analysis of the obtained results will be supplemented with publicly available data from the Central Statistical Office (GUS). The analyzed Emergency Medical Activity Cards will be evaluated according to the Utstein Out-of-Hospital Cardiac Arrest Registry template from 1991, with subsequent updates, the latest being in 2024, published under the title: "Cardiac arrest and cardiopulmonary resuscitation outcome reports: 2024 update of the Utstein Out-of-Hospital Cardiac Arrest Registry template - ILCOR Scientific Statement." 3. Study Population Adults who experienced out-of-hospital cardiac arrest in 2023. 4. Inclusion and Exclusion Criteria Exclusion Criteria: Age under 18 years. Inclusion Criteria: Emergency Medical Activity Cards containing at least one of the following criteria: In section IV DIAGNOSIS with ICD-10 codes: I46, R98, R96. In section III EXAMINATION, interview data indicating that bystanders initiated CPR. ResearchGate * 1 PMC * 1 In the SYMPTOMS table, marked as cardiac arrest. In the ECG table, marked rhythms: VF/VT, Asystole, PEA. In the PATIENT MANAGEMENT table, marked: MANUAL CHEST COMPRESSIONS, MECHANICAL CHEST COMPRESSIONS, DEFIBRILLATION. In the DEATH-WITHDRAWAL table, information on the reason for discontinuing resuscitation efforts. Only adult patients will be included in the study. Available demographic data will include patient age, gender, and the territorial area of the medical event, indicated by the location of the call and the voivodeship. 5. Estimated Study Group Size 100,000 records. 6. Estimated Study Duration The study is planned for a period of 6 months. References: European Resuscitation Council Guidelines 2021. Gräsner JT, Bray JE, Nolan JP, et al. "Cardiac arrest and cardiopulmonary resuscitation outcome reports: 2024 update of the Utstein Out-of-Hospital Cardiac Arrest Registry template - ILCOR Scientific Statement."

A Monitoring System Based on the Multifactorial Dynamic Perfusion Index to Predict and Prevent the Onset of Postoperative Acute Kidney Injury After Cardiac Surgery, Based on a Dynamic Collection of Hemodynamic and Clinical Parameters During Cardiopulmonary Bypass

This project is based on a predictive alghorithm (Multifactorial Dynamic Perfusion Index-MDPI) already published and covered by a patent. The MDPI is based on a dynamic collection of 7 different variables during cardiopulmonary bypass (CPB) and provides a probability index for postoperative acute kidney injury. The study design is a multicenter observational prospective trial developed through 3 work packages, addressing (1) external validation of the MDPI in a series of 800 adult cardiac surgery patients collected in 2 Institutions (2) development of a novel MDPI to be applied in infants \< 20 kg undergoing cardiac surgery (200 patients) and (3) verification of of other possible outcomes that may be predicted by the MDPI. Since many of the predictive variables are modifiable by the perfusionist/anesthesiologist during CPB, it is a tool that allows therapeutic manouvres. Ultimately, the MDPI will be incorporated in a dedicated monitor to provide an on-line "flight control" during CPB. Work package 1 will be performed at Units 1 and 2; the parameters composing the MDPI will be collected using the existing CPB monitors that routinely measure the hematocrit, the oxygen delivery, the time of exposure to a pre-defined critical oxygen delivery, the mean arterial pressure, and the CPB duration. Blood lactates and transfusions will be manually inputed. The MDPI will be calculated off-line and tested for association and predictivity (discrimination and calibration) with respect to postoperative AKI defined according to the K-DIGO classification. Workpackage 2 is dedicated to infants, with the purpose of developing an MDPI dedicated to low-weight infants (I-MDPI). This will be develop in Unit 1 that performs congenital heart surgery. The same variables of the MDPI will be collected, plus additional variables specific for infants (blood to prime the oxygenator, plasma for the same purpose; venous oxygen saturation, and others). The variables being independently associated with AKI will enter a logistic regression equation that will be the basis for the I-MDPI. Workpackage 3 considers that AKI is associated with a prolonged mechanical ventilation time, prolonged stay in the intensive care unit and in the hospital; and mortality. Therefore, the MDPI may be predictive of other postoperative complications, apart from AKI, and even of mortality. Some of the factors included in the MDPI may directly (low hematocrit) or indirectly (prolonged CPB duration, excessive hemodilution, low mean arterial pressure) affect the hemostatic system and/or trigger packed red cells transfusions. Additionally, CPB itself is a determinant of a coagulophatic state with associated postoperative bleeding which, in turns, increases the mortality. The specific aim 3 is to confirm the hypothesis that the MDPI may be predictive of one or more of this non-AKI postoperative complications and of 30-days mortality. In the same series of work package and aim 1, these complications will be collected and the MDPI tested for predictive ability of each one of these complications and 30-days mortality. At present, the MDPI can only be calculated off-line, and this greatly limits its applicability. The last step of the aim 3 is based on the involvement of software experts and partnership with companies interested in including the MDPI into their existing monitors; as such, the MDPI patent would be given under licence of the existing patent owned by the IRCCS Policlinico San Donato.

Health Literacy As a Mediator Between Gender, Illness Identity, and Self-Efficacy

The goal of this observational study is to understand the role of health literacy in shaping the relationship between gender differences, illness identity, and self-efficacy in geriatric patients with cardiac diseases. The main question it aims to answer is: Does health literacy mediate the relationship between gender, illness identity, and self-efficacy in elderly cardiac patients? Participants with diagnosed cardiac conditions, will complete online surveys assessing their health literacy, illness identity, and self-efficacy over a one-year period. Structural Equation Modeling (SEM) will be used to analyze the relationships among these variables.

Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)

The aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. The study leverages pharmacovigilance databases such as the World Health Organization (WHO) database (VigiBase), FDA Adverse Event Reporting System (FAERS), and others to gather individual safety case reports for analysis.