Clinical Research Directory

AI-guided Prediction and Treatment of Cardiac Arrest

Sudden cardiac arrest is a major health problem, and most people don't survive. One big reason is that even if resuscitation is successful, people commonly have recurrent cardiac arrests (rearrest). Right now, it is not possible to accurately predict a rearrest or prevent it. The investigators have developed a machine learning device that uses the heart tracing (ECG) to predict when and why a rearrest occurs. The investigators plan to test if it will accurately and effectively help EMS providers predict rearrest and provide timely treatment to increase survival after cardiac arrest. To determine if this machine learning device will work in the real world, the investigators need to find out if there are barriers to using it, and whether EMS providers will think it is useful and will help them improve the care of patients who have a cardiac arrest. The investigators will first test the device in live simulated cardiac arrest scenarios to see if the providers can use it and if they find the device potentially valuable in taking care of patients. In a second study, the investigators will test how accurate the device is in predicting if a cardiac arrest will happen again in patients who have just been brought back to life after a cardiac arrest. EMS providers will attach the device, but it will only work in the background. EMS will take care of patients as they normally would, without using or knowing what the device says. To see if the device is accurate at predicting another cardiac arrest, the investigators will analyze the results offline, and compare what the device says to what actually happens to the patient. By comparing what the device predicts to what actually happens, the investigators can see how well it predicts another cardiac arrest and estimate how it might improve treatment of patients.

Prediction of ARrhythmic Events With Positron Emission Tomography II

Sudden cardiac death continues to be a major contributor to mortality in patients with ischemic cardiomyopathy. While implantable defibrillators can prevent death from ventricular arrhythmias, our current approach to identify patients at highest risk primarily rests on demonstrating a reduction in left ventricular ejection fraction less than 35%. The purpose of this observational cohort study is to prospectively test whether this can be enhanced by quantifying the amount of sympathetic denervation, left ventricular end-diastolic volume or brain natriuretic peptide levels.

Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD

Long-term sudden cardiac death (abbreviation: SCAR) focuses on improving the predictability of sudden cardiac death (SCD) in patients diagnosed with coronary artery disease. The aim of the study is to determine the predictive value of measurable biological variables (including genetic factors, cardiac electrical activity, biological markers measured from circulation, and coronary artery anatomy) as well as the patients' psychosocial factors in predicting SCDs. The purpose of this study is the identification of a subgroup of coronary artery disease patients at sufficiently high risk in whom it may be possible to prevent sudden cardiac arrests and subsequent deaths using implantable cardioverter-defibrillators. The study is intended to establish a clear foundation for future interventional studies targeting high-risk coronary artery disease patients. The primary endpoint of the study is SCD/sudden cardiac arrest (SCA) or a comparable malignant arrhythmic event (i.e., resuscitation). Secondary endpoints include other major cardiovascular events occurring during the follow-up period (such as cerebrovascular events, myocardial infarctions, revascularizations, and new arrhythmias like atrial fibrillation following procedures or after the patient has been discharged following recruitment) or the occurrence and mortality of other significant life-threatening diseases (such as cancer). Secondary endpoints also include poor success in secondary prevention, which can be assessed through completed medication purchases and the achievement of secondary prevention goals. This observational, prospective study includes collecting multimodal data from hospitals in Finland (TAUH), Israel (HYMC), Moldova (IMSP) and Romania (UMFCD). Each participating institution has followed a process structured by Tampere Heart Hospital (TAUH) for securing permissions in line with EU and national regulations.

Research on Attitudes, Confidence, and Practical Skills in Performing Cardiopulmonary Resuscitation and Automated External Defibrillation After Completing a Course Based on the European Resuscitation Council Model

Research on attitudes, confidence, and practical skills in performing cardiopulmonary resuscitation and automated external defibrillation after completing a course based on the European Resuscitation Council model

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.

Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America

The overall goal of this project is to design, develop, and pilot test an emergency healthcare drone delivery system suitable for rural communities that can deliver AEDs to out-of-hospital cardiac arrest (OHCA) locations more rapidly than can be achieved with current first responder and EMS systems. The goal is to determine whether this method of AED delivery can be achieved rapidly enough to justify a future clinical trial directly testing its ability to improve OHCA survival.

ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)

Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.

Assessment of Combined CCM and ICD Device in HFrEF

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.

Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People

The goal of this observational study is to learn if two specific heart electrical signal patterns can help in detecting the risk of dangerous heart rhythms in athletes, and to see if exercise-based tests can be used instead of invasive hospital procedures to record this electrical signals. The main questions it aims to answer are: 1. Can special ECG action potential duration markers (R2I2 and PERS) identify athletes who are at higher risk of sudden heart rhythm problems. 2. Can an exercise test give the same information as a non-invasive electrophysiology study. Researchers will compare athletes who have an implanted heart device (ICD) with athletes who do not, to see if there are differences in these heart signals. Participants will undergo: 1. ECG recordings during rest and exercise. 2. If they have an ICD or pacemaker, an ECG will be recorded during a non invasive stimulation. 3. A continuous 24 hour ECG.

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."

Mayo AVC Registry and Biobank

Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death. The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples. Objectives of the study: 1. Discover new genes or altered genes (variants) which cause AVC 2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation) 3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data. 4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies

HeartStart FRx Defibrillator Event Registry

This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.

HeartStart HS1 Defibrillator* Event Registry

A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.

Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study

The goal of this observational study is to recognize clinical and genetic risk factors for sudden cardiac arrest (SCA) and death (SCD) in patients with coronary artery disease (CAD). The main questions it aims to answer are: Are we able to recognize clinical or treatment-related risk factors for SCA or SCD? Can we identify new genetic risk factors for SCA or SCD in patients under 75 years? Participants diagnosed with CAD answer a short survey about their medical history and socioeconomic status. A standard ECG addition to a five (5) minute ECG recording is taken from all the study subjects. In addition to a few short physiological tests (e.g. blood pressure, height, weight, grip strength), a blood sample is withdrawn from a selected group of study subjects. Medical healthcare records are used to follow all study subjects, and no follow-up visits are required.

The OSIRIS ECPR Trial

The OSIRIS trial is an investigator-initiated, multicenter, multinational, open-label, randomized controlled trial with a 2:1 concealed allocation of refractory out-of-hospital cardiac arrest (OHCA) patients to the extracorporeal cardiopulmonary resuscitation (ECPR) based approach versus the conventional cardiopulmonary resuscitation (CCPR) approach.

Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register

The increased risk of sudden cardiac arrest (SCA) or sudden cardiac death (SCD) related to vigorous physical activity is well-documented. Currently, for young victims (under 35 years) of SCA/SCD, no etiology is found in 40 to 50% of cases after a standard medical assessment, leading to two important consequences. For the victim's family, it is difficult to understand and accept this tragic event, and the risk of it occurring in another family member is a source of concern. Medically, the absence of a known cause limits the ability to effectively prevent such events. The RESOUDRE study will be a national, prospective, observational registry of young victims (12-35 years) of sports-related SCA/SCD. All cases will undergo the recommended etiological assessment, including autopsy for SCA cases, along with whole exome genetic analysis and toxicological testing. In the event a genetic pathology is identified, a genetic evaluation will be offered to other family members, and appropriate medical care will be provided if necessary. The results of this study could significantly reduce the number of unexplained sport-related SCA/SCD cases and aid in preventing these incidents among affected families.

HS Students Mandatory Universal Student Instruction in CPR Appraised Learning- Is the Mandate Working?

This study will help to provide better input to state health and education departments to improve the processes for CPR education. This will also help the EP council explore the opportunities to partner with other professional societies and other stake holders that have interest in this topic. Engagement of private-public partnerships for improving overall CPR education.

Hearts in Rhythm Organization (HiRO)National Registry and Bio Bank

The Hearts in Rhythm Organization (HiRO) is a national network of Canadian researchers/clinicians, working towards a better understanding of the rare genetic causes of sudden cardiac death (SCD). Canadian adult and pediatric electrophysiology centres across Canada work together to gather data and bio sample in a national data registry and bio bank hoping to improve the detection and treatment of inherited heart rhythm disorders to prevent sudden death.