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NCT04036695
Patients receiving dialysis for kidney failure suffer from very high rates of sudden cardiac death due to abnormal heart rhythms and perfusion defects associated with HD treatment. It has previously been recognized that patients suffer heart injury during the dialysis procedure which may be an important factor for investigation. The study uses a simple implantable device that can monitor heart rhythms over time to gather information on the type of abnormal rhythms that occur in dialysis patients. This information will be combined with ultrasound and x-ray scans of the heart that will also be collected. The goal is to understand the relationship between the abnormal rhythms and injury to the heart during dialysis and what causes these injuries. The information gathered in this study will be used to compare the accuracy of an in house personalized computational model to predict potential cardiac injuries when patients undergo HD treatment.
NCT06856993
Acute coronary syndrome (ACS) is one of the main causes of death. Worldwide, tens of millions of patients are hospitalized for coronary heart disease and ACS every year. ACS may show acute myocardial infarction, unstable angina pectoris, and even induce early arrhythmia, leading to sudden death. Sudden cardiac death (SCD) has a strong correlation with ACS. Data from clinical and autopsy studies and death certificates show that 62-85% of patients with out of hospital SCD have a history of ACS, 10% have other cardiac structural abnormalities, and 5% have no cardiac structural abnormalities. An SCD surveillance study from Ireland concluded that most cases occurred in families, and the successful recovery of SCD was mainly related to ventricular fibrillation with arrhythmia. At present, there are few reports on the clinical and prognosis of ACS in China, and there is no guideline or consensus on the prevention and treatment of ACS patients. Known domestic research results show that the proportion of male, overweight / obese, smokers in young ACS patients is higher than that in the elderly group, while the proportion of patients with hypertension, diabetes and cerebrovascular diseases is less than that of the elderly group. The levels of TC, TG, LDL-C and UA and the proportion of low HDL-C in young ACS patients were higher than those in elderly patients; The diagnosis of STEMI was the highest in the young ACS group, while the diagnosis of unstable angina pectoris was the most common in the elderly ACS group. The clinical manifestations of ACS vary greatly. 3% \~ 5% of patients who exclude ACS only through myocardial markers, clinical blood transfusion and ECG still have myocardial infarction (MI). For the emergency department, early prediction of the risk of SCD in ACS patients and timely and accurate screening of high-risk patients are very important.
NCT05373940
The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.
NCT07028372
Less than 10% of patients eliciting out-of-hospital cardiac arrest (OHCA) survive, although 30% can be resuscitated by Emergency services before admission in Intensive Care Units (ICU). The majority succumb to Post-Cardiac Arrest Syndrome (PCAS). PCAS is associated with high mortality (60-70%) and morbidity. One proposed method of preventing the neurological and cardiac consequences of PCAS is to lower the body temperature to 33°C as quickly as possible. This approach is known as therapeutic hypothermia or Targeted Temperature Management (TTM). The Vent2Cool system, developed by Orixha, is a novel approach that enables the rapid induction of therapeutic hypothermia by using hypothermic Total Liquid Ventilation (TLV) to reach a protective temperature of 33°C within minutes. The OverCool feasibility study, which started in April 2025, is designed to validate the clinical performance and safety of an ultra-rapid cooling approach combining ultra-rapid hypothermia induction using the Vent2Cool system, and maintenance and rewarming using the ArcticSun system. The AfterCool study aims to evaluate long-term outcomes during a five-year follow-up of cardiac arrest survivors who were treated with ultrarapid cooling in the OverCool study.
NCT07476456
This study is designed as a prospective, single-center, observational cohort study (the SMART-SCD Study, full name: Skeletal Muscle Multi-omics Analysis and Risk Tailoring in Sudden Cardiac Death), which enrolls high-risk populations meeting the criteria for implantable cardioverter defibrillator (ICD) implantation. The research focuses on the mechanistic association between skeletal muscle metabolic disorders and ventricular arrhythmia (VA) as well as sudden cardiac death (SCD), and aims to construct a "muscle-heart crosstalk" risk early warning system through integration of multimodal skeletal muscle data. We will systematically collect the following data: Baseline handgrip strength measurement (Biomi-h500+X5); Functional diagnosis and phenotyping of sarcopenia conducted via the InBody 270 body composition analyzer; Non-contrast chest and abdominal computed tomography (CT) images (to extract novel imaging phenotypes including skeletal muscle density at the T12 vertebra level, intermuscular adipose tissue, subcutaneous adipose tissue, etc.); Serum biomarkers (GDF-8, Irisin, IL-6); Metabolomics data of skeletal muscle tissue from the ICD pocket (lipid/energy metabolism profiles detected via the UPLC-QTOF/MS platform); Ambulatory electrocardiographic data. All treatment and intervention regimens for patients will be independently formulated by clinicians in accordance with clinical guidelines, and the study itself does not involve any intervention measures. Prospective follow-up will be conducted at 3/6/12 months after ICD implantation. The primary endpoint is composite ventricular arrhythmia events (including SCD, appropriate ICD therapy documented by the device, and hemodynamically unstable ventricular tachycardia/ventricular fibrillation), and the secondary endpoint is all-cause mortality. Through the above prospective cohort study, we will integrate multimodal data including novel CT imaging phenotypes of skeletal muscle, metabolomics profiles and functional phenotyping of sarcopenia using artificial intelligence techniques, so as to construct a precision prediction model for SCD, screen novel CT imaging phenotypes of sarcopenia and myogenic metabolites, and finally establish a generalizable SCD risk assessment tool and individualized intervention strategies.
NCT07444931
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.
NCT07438938
Out-of-hospital cardiac arrest (OHCA) is a leading cause of death worldwide. Despite constantly improving resuscitation techniques, the chances of survival remain limited. During cardiopulmonary resuscitation (CPR), a closure of the airway may occur, impeding ventilation. This phenomenon also complicates the interpretation of the end-tidal CO2 (ETCO2) in the capnogram. The extent to which airway closure occurs is quantified by the Airway Opening Index (AOI). This can be calculated from the capnogram and is seen as a measure of the quality of CPR applied as well as a possible indicator to predict the outcome of CPR. In this study, we analyse capnogram data from approximately 150 cases, collected during interventions for OHCA and logged in the Lazarus database (UZ Gent and AZORG) to answer three research questions below: 1. What is the prevalence of AOI during CPR? 2. Is there a correlation between AOI and return of spontaneous circulation (ROSC)? 3. Does the application of positive end-expiratory pressure (PEEP) affect the AOI and ROSC? A mathematical model for calculating AOI, based on a method from previous work by Bandhari et al. \[1\] will be developed. Using this model, the AOI will be calculated from the individual capnograms for all cases in the Lazarus database. In addition, a multivariable regression model will be used to analyse whether AOI can be used to predict ROSC. Corrections will be made for relevant confounders such as age, gender, witnessed arrest and rhythm pattern. Finally, it is investigated whether PEEP has a positive influence on AOI. This study aims to contribute to better insights into airway dynamics during CPR and the optimization of ventilation in OHCA.
NCT07415642
Research questions: The value of primary prevention implantable cardioverter-defibrillator implantation (ICD) therapy in patients with non-ischemic cardiomyopathy (NICM) is under debate. Improved risk stratification is needed to select patients at highest risk. Hypotheses: 1. In NICM patients with CMR detected myocardial fibrosis, ICD implantation reduces all-cause mortality compared to guideline-directed medical therapy (GDMT) only. 2. Myocardial fibrosis assessed by cardiac MRI (CMR) can be used to stratify patients according to risk for sudden cardiac death. Study design: 1. Patients with myocardial fibrosis: Randomized controlled trial (RCT). 2. Patients without myocardial fibrosis: Prospective registry. Study population: Patients with non-ischemic cardiomyopathy with LVEF \<35% after at least 3 months of guideline-directed medical therapy (GDMT). Intervention: ICD implantation. Main study parameters/endpoints: primary endpoint: all-cause mortality. Secondary endpoints include: patient clinical status, quality of life, sudden cardiac death, ventricular arrhythmias, ICD complications and ICD therapy Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All ICDs that are implanted in the study are standard devices that are used in daily clinical practice. Patients who are randomized to ICD implantation will be subjected to the risk of perioperative and long-term complications but will be partly protected against death from ventricular arrhythmias. Patients randomized to no ICD implantation will not be protected against the residual risk of sudden cardiac death but are not subjected to complications from ICD implantation and possible subsequent complications. The only additional burden for patients is completing quality-of-life questionnaires, all hospital visits are for routine follow-up.
NCT07372196
Pilot interventional randomized clinical trial to study the efficacy of left bundle branch pacing in patients with hypertrophic cardiomyopathy after myectomy for the prevention of progression of heart failure, prevent the occurrence of life-threatening rhythm disturbances and promote reverse remodeling of the LV. The aim of the study is to evaluate the comparative efficacy and safety of implantation of a cardioverter-defibrillator with left bundle branch block pacing and a dual-chamber cardioverter-defibrillator in patients with HCM and complete left bundle branch block after myectomy at high risk of SCD. Objectives of the study: 1. To analyze the safety of ICD implantation procedures with LBBB pacing in patients with HCM and LBBB after myectomy at high risk of SCD; 2. To develop a technique for LBBB lead implantation in patients with HCM and LBBB after myectomy; 3. To conduct a comparative analysis of QRS complex duration data based on ECG data before and after surgery, LV activation time, and pacing threshold based on postoperative programming data; 4. To conduct a comparative analysis of the functional class of CHF, NT-proBNP, the presence/absence of interventricular and intraventricular dyssynchrony, the degree of diastolic dysfunction, LVEF, and LV EDV based on echocardiography data before and 12 months after surgery; 5. Conduct a comparative analysis of QRS complex duration data based on ECG data, LV activation time, pacing threshold, the presence of recorded episodes of AF, VT, VF, antitachycardia and shock therapy according to programming data at 3, 6, and 12 months after surgery; 6. Assess quality of life before and 12 months after surgery using the KCCQ-12 questionnaire; 30 patients (15 patients in each group) will be randomly separated into 2 groups. All participants go through ICD programming at 3, 6, and 12 months after myectomy, assessment of left ventricular remodeling based on ECG and echocardiography, NT-proBNP, assessment of quality of life before surgery and 12 months after surgery.
NCT04856267
The overall aim of this study is to improve our understanding of the effects of the build-up of amyloid deposits in the heart, in particular, our understanding of the risk of abnormal heart beats, or rhythms, associated with people with cardiac (heart) amyloidosis. Symptoms such as palpitations (fast, strong or irregular heart beat) and blackouts are common in people with cardiac amyloidosis, but there is not enough information on what causes this. At present, there is also not enough information on when they occur, how often they happen, and which patients are at risk of having serious, life-threatening types of abnormal heart rhythms. Some of these abnormal heart rhythms can be treated with medicine; others need electronic devices (e.g. pacemakers) implanted or inserted in the heart to prevent serious harm. The information on when is the best time to implant these life-saving devices remains limited. In this study, a small device known as an implantable loop recorder (ILR) will be implanted under the skin on the chest wall to continuously monitor participants' heart rhythm. This will help us answer some of the questions about what causes the abnormal heart rhythms, when they happen, and which patients are particularly likely to have them. Furthermore, it may help us to identify earlier, rather than later, those who are at risk of developing abnormal heart rhythms. This may lead to improvements in the care of people with cardiac amyloidosis in the future. Participants may not directly benefit from taking part in this study; however, there is a chance that the ILR may reveal heart rhythm abnormalities in some participants which might not be picked up otherwise, and so may lead to a change in their treatment.
NCT06964464
This prospective, multicenter, open-label, randomized comparative effectiveness trial, titled CARVTOP-ICD, evaluates the impact of carvedilol versus metoprolol succinate in patients with heart failure with reduced ejection fraction (HFrEF) and an implantable cardioverter defibrillator (ICD). The study will enroll 2,000 participants across 100 U.S. sites and includes an 18-month feasibility phase with 100 participants from 15 sites. Eligible participants must be currently treated with metoprolol succinate and willing to switch to carvedilol, with randomization in a 1:1 ratio. Participants will be followed for up to 3 years, with regular assessments including ICD interrogations, medication adherence, healthcare utilization, and quality of life surveys. The primary endpoint is the first occurrence of any ICD therapy (appropriate or inappropriate), cardiovascular (CV) hospitalization, or CV death. Secondary endpoints include ICD shock burden, healthcare utilization, and patient-reported quality of life. The trial aims to provide high-quality comparative data to address clinical equipoise surrounding the two commonly used beta-blockers in HFrEF management.
NCT00170313
The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "Conducted-Atrial Fibrillation (AF)-Response-Algorithm (CAFR)". This algorithm is designed to maximize biventricular stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs. The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering from atrial fibrillation by quantification of the increase of biventricular pacing during atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular heart rate.
NCT03079414
Sudden cardiac death (SCD) remains a major cause of mortality within developed nations despite aggressive efforts to reduce its societal burden. Despite extensive clinical and genetic investigations, a subgroup of cardiac arrests remain unexplained, highlighting the potential contribution of additional cardiac conditions that may not be identified with contemporary diagnostic algorithms. The EPS ARREST study aims to evaluate the role of invasive electrophysiology study within this patient population.
NCT04036799
This is a retrospective cohort study of pediatric hypertrophic cardiomyopathy (HCM) patients using chart and registry review methodology. The studies objective is to develop and validate a sudden cardiac death (SCD) risk calculator that is age-appropriate for children with HCM that includes clinical and genetic factors.
NCT06954103
The incidence of stroke-heart syndrome following acute stroke, which encompasses both acute ischemic stroke and acute intracerebral hemorrhage, is notably high and is strongly associated with increased mortality and poor outcomes in stroke patients. However, the underlying mechanisms remain unclear, and there are currently no effective prevention or treatment strategies. This study aims to elucidate the neuro-humoral mechanisms of stroke-heart syndrome through multimodal imaging and multi-omics blood analysis. Additionally, it seeks to observe the progression of stroke-heart syndrome and its impact on functional outcomes, cognitive abilities, and emotional issues post-stroke. The research is expected to uncover novel blood biomarkers and brain network mechanisms associated with stroke-heart syndrome, providing potential targets and theoretical foundations for pharmacological treatments or physical interventions. Furthermore, it aims to establish a risk early-warning system for major cardiovascular complications post-stroke, enabling early identification, early intervention, and integrated brain-heart management to improve clinical outcomes for stroke patients.
NCT03016754
This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.
NCT06642168
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.
NCT03319160
This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.
NCT06718465
Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks. In the United Kingdom heart attacks are the commonest cause of death. Combined positron emission tomography (PET) and computer tomography (CT) scans are a new way of assessing atherosclerosis. Using the radiotracer 18F-Fluoride, this study proposes to perform combined PET CT scans on post-mortem hearts from participants with or without a history of heart disease. It will then be able to compare the hot spots found on these scans with what investigators can see under the microscope when looking at heart artery specimens, assess which genes are switched on and proteins present in the hot spots. This will give us an insight into what hot spots on PET CT scans are identifying in areas of atherosclerosis. It will also provide new information relating to the underlying processes that give rise to atherosclerosis and the development of heart attacks. This will pave the way for the future development of new treatments.
NCT04024865
The purpose of this study is to determine whether the use of domperidone is associated with an increased risk of serious cardiac events among postpartum women in the six months following delivery. The hypothesis is that the use of domperidone will be associated with an increased risk of serious cardiac events among postpartum women. The investigators will carry out separate population-based cohort studies using health care databases in five Canadian provinces. Women with live births will be eligible to enter the cohort. We will identify all women who start domperidone during the six months following delivery and match them to similar women who do not start domperidone, with all included women followed until the occurrence of an adverse cardiac event or for up to six months after delivery. The results from the separate sites will be combined to provide an overall assessment of the risk of serious cardiac events in users of domperidone.