Clinical Research Directory

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.

MEdical Treatment in Idiopathic Ventricular Fibrillation Patients

A person who has experienced a cardiac arrest with no apparent cause is at risk of having recurrent cardiac arrest. Hence an implantable cardioverter-defibrillator (ICD) is recommended on empirical grounds. Today, there is no uniform way of approaching prevention of recurrence in idiopathic ventricular fibrillation (IVF) patients, beside ICD implantation. Better reatment and risk stratification tools are needed Medical treatment in these patients has never been assessed systematically, but at least some patients with no apparent diagnosis are on betablocker treatment. It is not known if low-doselow dose betablocker treatment is beneficial in these patients. This study investigates the effect of betablocker treatment to reduce arrhythmic burden in IVF patients. No predictors for appropriate ICD therapy have been identified in patients with IVF. It is also explored if toxicological and/or genetic profiles, together with in depth machine learning simulation data on repolarization patterns from IVF-ECGs compared to controls, can be used as risk stratification tools. Lastly, QOL in IVF patients and the impact of beta blocker treatment will be investigated.

Prehospital ECPR in Moravia Silesia Region

Cardiopulmonary resuscitation (CPR) for out-of-hospital cardiac arrest (OHCA) in specific cases could be improved by Extracorporeal membrane oxygenation (ECMO; ECPR). ECPR could be introduced in hospital after retrieval of an OHCA patient and also faster by implantation on scene. The aim is to verify the effectiveness of ECPR on scene in the Moravian-Silesian region.

Resuscitative TEE Collaborative Registry

The general objective of this study is to evaluate the clinical impact and safety of focused, point-of-care transesophageal echocardiography (TEE) used during the evaluation of critically-ill patients in the emergency and intensive care settings. The target population for this study are critically-ill patients over the age of 18 who as part of their routine clinical care are receiving a focused TEE. The primary objective of this study is to determine the clinical impact and safety of TEE performed during the evaluation of critically-ill patients in the emergency department and intensive care settings. The secondary objective(s) of this study are to characterize the use of this imaging modality in the subsets of critically-ill patients in shock and cardiac arrest; including but not limited to; description of the frequency of studies, clinical indications, clinician characteristics, echocardiography findings, timing of studies, procedure-related complications and patient outcomes.

Cardiac Arrest Pursuit Trial With Unique Registration and Epidemiologic Surveillance

Identification of Causes and Risk Factors for Out-of-Hospital Cardiac Arrest through Development of Prediction Model and Novel Biomarkers Study Objectives: 1. To identify causes and risk factors of OHCA incidence that are associated with chronic diseases and health behaviors 2. To identify high risk population for OHCA incidence through development of a prediction model 3. To develop novel biomarkers associated with OHCA incidence, survival, and disabilities

Epinephrine Dose: Optimal Versus Standard Evaluation Trial

The objective of this randomized controlled trial is to evaluate the effectiveness of a low cumulative dose of epinephrine compared to a standard cumulative dose of epinephrine during resuscitation from ventricular fibrillation (VF) or ventricular tachycardia (VT) in adult out-of-hospital cardiac arrest (OHCA) patients.

CardioPulmonary Resuscitation With Argon (CPAr) Trial

Preclinical studies suggest that argon (Ar) might diminish the neurological and myocardial damage after any hypoxic-ischemic insult. Indeed, Ar has been tested in different models of ischemic insult, at concentrations ranging from 20% up to 80%. Overall, Ar emerged as a protective agent on cells, tissues and organs, showing less cell death, reduced infarct size and faster functional recovery. More specifically, encouraging data has been reported in animal studies on cardiac arrest (CA) in which a better and faster neurological recovery was achieved when Ar was used in the post-resuscitation ventilation. More importantly, these benefits have been replicated in different studies, enrolling both small and large animals. Finally, ventilation with Ar in O2 has been demonstrated to be safe both in animals and humans. Based on this evidence, a clinical translation is advocated. Thus, the CardioPulmonary resuscitation with Argon - CPAr trial has been conceived. The trial initially started as phase I-II trial to specifically address the question about the safety of the post resuscitation Ar-treatment. The available data on the first 30 randomized patients, evaluated by the Data Safety Monitoring Board (DSMB), were considered absolutely reassuring with regard to the safety of the experimental treatment. In this perspective, the DSMB supported the continuation of the study as a phase II trial, maintaining the study protocol in all its aspects. Thus, the aim of the CPAr trial is now to evaluate efficacy in reducing post-CA neurological injury of Ar/O2 ventilation in patients resuscitated from CA.

AED 3 Post-Approval Study

Demonstrate appropriate CPR sensor placement on pediatric and adult patients and demonstrate delivery of appropriate energy level of shocks to pediatric and adult patients.

AID-OMIE - Artificial Intelligence in Detection of Occlusive Myocardial Infarction in Emergency Medicine

Study Objective and Hypothesis The study hypothesizes that artificial intelligence (AI)-assisted interpretation of the 12-lead electrocardiogram (ECG) can improve the care of patients resuscitated after out-of-hospital cardiac arrest (OHCA) by enabling faster and more accurate detection of occlusion myocardial infarction (OMI). This enhanced diagnostic approach could reduce the time required for revascularization, improve patient outcomes, and decrease unnecessary activations of cardiac catheterization laboratories. The primary objective of the study is to assess the effectiveness of an AI-powered ECG model in identifying acute OMI in OHCA patients whose post-return of spontaneous circulation (ROSC) ECG does not show ST-elevation. Methods This is a retrospective observational study involving OHCA patients in Bolzano, Italy, who meet the following inclusion criteria: Aged 18 years or older. Achieved ROSC after cardiac arrest. Underwent coronary angiography (CAG) within seven days post-OHCA. Prehospital post-ROSC ECG and CAG reports available. Exclusion criteria include in-hospital cardiac arrest (IHCA), traumatic cardiac arrest, cardiac arrest from a non-cardiac cause, and poor-quality or corrupted ECG images. Post-ROSC ECGs will be analyzed using the PMcardio App, an AI tool for ECG interpretation. The data will be fully anonymized before storage. Coronary angiography charts will be reviewed for the presence of atherosclerotic lesions, the degree of arterial narrowing, and Thrombolysis in Myocardial Infarction (TIMI) flow, which assesses blood flow in coronary arteries. Study Outcomes The primary outcome is the sensitivity and specificity of the AI-assisted ECG in detecting OMI in patients whose post-ROSC ECG does not show ST-elevation. Secondary outcomes include the frequency of OMI in OHCA patients without ST-elevation and the ability of the AI model to rule out OMI accurately in these cases.

Late Biomarkers in Adult Survivors After Out-of-hospital Cardiac Arrest

Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.

Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients

A multicenter, randomized, adaptive allocation clinical trial to determine if increasing durations of induced hypothermia are associated with an increasing rate of good neurological outcomes and to identify the optimal duration of induced hypothermia for neuroprotection in comatose survivors of cardiac arrest.

Validity of ICU Clinician's Appraisal of Proportionality in CPR

The VICAP-CPR study investigates whether doctors and nurses working in Intensive Care can determine neurological outcome and future quality of life after six months in patients treated for cardiac arrest outside the hospital based on clinical assessment in the first 24 hours after admission to Intensive Care. To conduct this study, the results of the questionnaire offered to Intensive Care doctors and nurses regarding the estimation of long-term neurological outcome and quality of life will be compared with the neurological outcome and quality of life as recorded in the STEPCARE study (NCT 05564754). The aim of the international STEPCARE study is to determine the best combination of post-resuscitation care to favourably influence survival and neurological outcome in patients treated for cardiac arrest outside hospital.

International Device Assisted Controlled Sequential Elevation CPR Registry

The purpose of this prospective observational cardiopulmonary resuscitation (CPR) registry is to track the use and clinical outcomes from emergency medical systems across the US and Europe that have implemented a system of care approach applied rapidly to cardiac arrest that includes using the combination of an impedance threshold device (ITD), and either manual active compression-decompression (ACD) CPR device or automated compression device, with a Head Up CPR device.

Gathering Evidence on Best Practices for Lay Rescuer CPR Training

The goal of this prospective trial is to compare CPR skill and attitudes in lay rescuers. The main question\[s\] it aims to answer are: * What is the optimal training timing, duration, and frequency for lay rescuers that leads to CPR skill retention? * What is the impact of CPR manikin type (high-fidelity, inflatable, nontraditional objects) on skill retention? * How do specific features of training modality -- such as contextualization, gamification, and emotional engagement -- impact skill proficiency, knowledge retention, and attitudes about CPR? Participants will * Answer pre-training questionnaires * Participate in CPR training * Participate in CPR skills testing * Answer post-training questionnaires Researchers will compare different methods of training, different frequencies of training, and different manikin types.

Direct or Subacute Coronary Angiography in Patients With Out of Hospital Cardiac Arrest Without Coma.

In patients with Out-of-Hospital Cardiac arrest who achieves Return Of Spontaneous Circulation (ROSC) The investigators want to evaluate whether there is a benefit from acute Angiography compared to subacute (12-24 hours) Angiography

Evaluation of Updated Procedure for Management of Refractory Out-of-hospital Cardiac Arrests

ECPR is a technique that has been rapidly developed in many cardiac arrest specialized centers In 2013, a specific management protocol was developed for patients in refractory out-of-hospital cardiac arrest around Nancy, France. To select patients with the best prognosis, the inclusion criteria defined were strict. This led to an over-selection of patients and a significant reduction in the number of eligible patients. A balance needed to be struck between over-selecting patients and maintaining the expertise of medical and paramedical teams in the field. In addition, it has also been shown that ECPR also increases the number of organs and transplants. In February 2024, the criteria for inclusion in the protocol were redefined to include any witnessed non-traumatic cardiac arrest, whatever the initial rhythm. This simplification should enable more patients to be included in the procedure. The aim of the study is to assess the patient's outcome

Synergy of Elevation of the Head and Thorax and REBOA During Out-of-Hospital Cardiac Arrest

Long-term neurological outcome after successful resuscitation of cardiac arrest remains poor, mainly due to cerebral hypoperfusion and severe hypoxic-ischemic brain injuries. Automated head and chest elevation during cardiopulmonary resuscitation (AHUP-CPR) improves cerebral perfusion by decreasing the intracranial pressure and increasing cerebral perfusion in experimental pig studies. The addition of an impedance threshold device (ITD) and active chest compression-decompression device (ACD) improved hemodynamics and cerebral perfusion. In addition, early implementation of AHUP-CPR in patients with out-of-hospital cardiac arrest (OHCA) was associated with improved survival to hospital discharge, in a multicenter observational study. A 2-year prospective clinical trial in Grenoble evaluating this combination was just completed. This study showed for the first time that the value of end-tidal CO2 (EtCO2), a surrogate for cardiopulmonary resuscitation (CPR) quality and cardiac output, measured with this combination therapy, was significantly higher than with standard CPR. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has recently been proposed during CPR. This technique temporarily diverts blood flow to the coronary and cerebral circulation. Its beneficial effect on hemodynamics, cerebral blood flow and survival has been experimentally validated. In several feasibility studies, encouraging results were observed by slightly optimizing cerebral perfusion and coronary pressure when REBOA was used in combination with standard CPR. In a porcine model of cardiac arrest, the addition of REBOA to AHUP CPR was associated with a marked improvement in coronary perfusion pressure and near-normalization of cerebral perfusion pressure. These two interventions act synergistically. REBOA directs flow and pressure to the heart and brain, while AHUP CPR improves preload on the right side of the heart and reduces intracranial pressure. The aims of this clinical investigation are to assess the feasibility of placing a REBOA catheter combined with automated CPR with head and chest elevation, and to quantify the associated changes in clinical parameters for OHCA.

Pulse Checks Using Femoral Artery B-Mode Ultrasound With Compressibility Assessment

The goal of this prospective observational study is to investigate B-mode point-of care ultrasound with arterial compressibility assessment on the femoral artery as a method to determine the presence of a pulse and to compare it with concurrently conducted manual pulse checks.

Prediction of Delayed Cognitive Impairment in Cardiac Arrest Survivors With Good Neurological Outcomes

The objective of this observational study is to provide basic data for predicting and analyzing the occurrence and causes of delayed cognitive impairment, an important factor in the quality of life, among discharged patients who have received targeted temperature management therapy and experienced favorable neurological outcomes after out-of-hospital cardiac arrest. The main questions it aims to answer are: * Can we identify abnormal areas in the brains of patients with delayed cognitive impairment using Brain MRI or positron emission tomography (PET) imaging? * Is it possible to predict delayed cognitive impairment using biomarkers?