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NCT ID: NCT03214328 Recruiting - Clinical trials for Intrauterine Fetal Death

Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing

EMIBICI
Start date: November 21, 2019
Phase:
Study type: Observational

Intrauterine fetal death (IUFD) is defined as the occurrence of fetal death at >20 weeks' gestation. IUFD affects about 1 in 160 pregnancies (6-7 per 1000 births). Optimal diagnostic evaluation for cases of IUFD is generally based on extensive protocol testing i.e. maternal and fetal blood tests, fetal bacteriology, cytogenetic analysis, autopsy, and placental examination. This extensive protocol testing may vary in clinical practice and interpretation of the results is rarely performed by multidisciplinary staff to establish cause of death. These findings are related to the fact that there are very few epidemiological studies to validate optimal protocol, no French recommendations on this subject, and a relative lack of pathologists with expertise in perinatal pathology. Only, one recent prospective study from the Netherlands has concluded that extensive protocol testing should be redefined and some diagnostics tests may only be performed with suggestive clinical circumstances. However these recommendations may not be applicable to all populations and countries. To date, there are no French published series on IUFD to evaluate causes of death in France and thereafter to better define optimal diagnostic evaluation tests. Improvement in prenatal diagnosis in France may contribute to detection of the vast majority of severe chromosomal abnormalities and malformed fetuses and particularly those at risk of death. Retrospective cohort unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to chromosomal or malformation abnormalities. In fact in these two series, most deaths were related to placental diseases or fetal growth retardation. The hypothesis is that extensive protocol testing is not helpful in clinical practice and selective protocol testing focused on specific risk situations can be as efficient.

NCT ID: NCT03209674 Recruiting - Heart Diseases Clinical Trials

Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry

RIPOSTE
Start date: January 1, 2012
Phase:
Study type: Observational [Patient Registry]

The registry for the improvement of postoperative outcomes in cardiac and thoracic surgery aims to prospectively collect data in order to test the association between various preoperative and per-operative variables ; and several postoperative outcomes such as mortality, shock, redo surgery, sepsis and extracorporeal life-support.

NCT ID: NCT03109197 Recruiting - Clinical trials for Sudden Unexplained Death Syndrome

Sudden Unexplained Death in Childhood (SUDC) Registry

SUDC
Start date: October 1, 2014
Phase:
Study type: Observational [Patient Registry]

The purpose is to increase the understanding of the characteristics, circumstances, medical histories and pathologies of children from ages 11 months through 18 years who have died suddenly and unexpectedly, and in some instances, without explanation. The SUDC Registry and Research Collaborative will analyze cases of sudden unexpected deaths in these children to understand risk factors and causes, and develop preventative measures.

NCT ID: NCT03079414 Recruiting - Clinical trials for Sudden Cardiac Death

The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest

EPS ARREST
Start date: May 1, 2017
Phase:
Study type: Observational

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.

NCT ID: NCT03049254 Recruiting - Clinical trials for Cardiovascular Diseases

Mayo AVC Registry and Biobank

Start date: February 9, 2018
Phase:
Study type: Observational

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

NCT ID: NCT03002350 Recruiting - Recurrence Clinical Trials

Clinical Relevance of NGS Analysis for High-purity CTC From Cancer Patients With Disruptive Gene Mutation(s)

Start date: August 2016
Phase: N/A
Study type: Observational [Patient Registry]

Distant metastasis of cancer remains the major cause of cancer death. One of the evidence is that some rare cells shed from primary tumor exist in the circulation of cancer patients, which has been proven to be related to cancer relapse and distant metastasis. The number of circulating tumor cells (CTCs) or the expression status of specific marker(s) on them also correlated with the disease prognosis and treatment effects, which might change the decision of treatments. In recent years, as specific disruptive genes were discovered, such as epidermal growth factor receptor (EGFR) in non-small cell lung cancer,Kirsten rat sarcoma (KRAS) in colorectal cancer, the response rate to treatment, disease control and survival have been much improved. However, the molecular information obtained from cancer tissue depends on repeated biopsies, which is very risky and invasive to cancer patients. By means of the advances of CTCs sampling technique with genetic analysis, repeated follow-up for specific gene profiles is possible. However, the protocol has not been well-established and mature, even the correlation between primary cancer tissue and CTCs remains unknown. To tackle the problems above, the aims of the project is to isolate high-purity CTCs by the optically induced dielectrophoresis (ODEP)-based device or other cell sorting techniques and transfer to next-generation sequencing (NGS) analysis for specific disruptive genes. In the first year of the project, the investigator will testify and stabilize the platform utilizing healthy donors' blood and cancer cell lines and adjust the detailed experiment conditions. In the following year, the investigator will enroll newly diagnosed metastatic cancer patients with the disruptive gene mutation(s) and follow up the events under gene-based therapy. Comparison of NGS information between cancer tissue and CTCs will be also made as one of the major endpoints. In brief, the investigator expect the study could establish a practical method to get genetic information, to reduce the risk of re-biopsy and to achieve the ultimate goal of precision medicine.

NCT ID: NCT02982473 Recruiting - Clinical trials for Ventricular Tachycardia

Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions

RACE-IT
Start date: April 2016
Phase:
Study type: Observational

The "Registry of Malignant Arrhythmias and Sudden Cardiac Death - Influence of Diagnostics and Interventions (RACE-IT)" represents a mono-centric registry of patients being hospitalized suffering from malignant arrythmias (ventricular tachycardia or fibrillation) and sudden cardiac death (SCD). Detailed findings of patients' clinical outcome regarding mortality and co-morbidities related to the presence of invasive diagnostics or therapies including coronary angiography, percutaneous coronary intervention (PCI), electrophysiological testing (EP), catheter ablation and implanted cardiac devices (e.g. implantable cardioverter-defibrillators) will be documented. Patients will be included when being hospitalized from the year 2004 until today.

NCT ID: NCT02920203 Recruiting - Sudden Death Clinical Trials

Genetic Autopsy and Sudden Death

AGEMOS
Start date: October 11, 2017
Phase: N/A
Study type: Observational

The purpose of the study is to better identify hereditary cardiac causes of sudden unexpected death in young subjects through Next-Generation Sequencing of autopsy tissue

NCT ID: NCT02874469 Recruiting - Clinical trials for Sudden Cardiac Arrest

Impact of an Intensive Care Diary on Post-traumatic Stress Disorder After a Resuscitated Sudden Death

COREABOR
Start date: December 31, 2014
Phase: N/A
Study type: Interventional

Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year. Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life. Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context. Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death. Secondary objectives - To evaluate the frequency of the occurrence of a "post traumatic stress syndrome" and other psycho traumatic symptoms after sudden death - To evaluate the impact of an intensive care unit diary on the severity of this syndrome, psycho traumatic symptoms, and psychopathologic comorbidities - To evaluate the impact of the diary on psycho traumatic symptoms and their severity in patient's relatives - To evaluate the satisfaction of the patients and their relatives regarding medical cares in both groups (with and without diary) - Comparison of nurse diagnostic (psychological distress) and diagnostic made by dedicated personal with a specific formation in psychology - Qualitative evaluation of the diary - Evaluation of the paramedical feeling before and after the diary input in practice

NCT ID: NCT02845531 Recruiting - Clinical trials for Sudden Cardiac Death

Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death

VARIANT ICD
Start date: November 29, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause compared with optimal medical therapy alone.