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Death, Sudden, Cardiac clinical trials

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NCT ID: NCT03725826 Completed - Clinical trials for Acute Myocardial Infarction (AMI)

Risk Stratification After Acute Myocardial Infarction With Cardiac MRI

CR-2280
Start date: May 2013
Phase:
Study type: Observational

Given the existing controversy regarding the appropriate determination time for placement of implantable cardioverter-defibrillator (ICD) in patients at risk for sudden cardiac death (SCD) following acute myocardial infarction (AMI), the modest ability of current criteria to determine which patients will experience SCD, and the high impact of SCD to society, we propose to conduct a prospective non-randomized observational study to determine: - Whether quantification of left ventricular (LV) scar volume by cardiac magnetic resonance (CMRI) prior to hospital discharge helps to predict which patients will have a low ejection fraction (35%) at follow up and qualify for ICD implantation. - Whether quantification of infarct scar volume by CMRI will help to identify which patients will experience malignant ventricular arrhythmias and/or SCD at follow-up, independent of the LV ejection fraction (LVEF). Primary hypothesis: Percentage of left ventricular scar volume as measured by CMRI post-MI strongly correlates with LVEF at 40 days and 3 months. Secondary hypothesis: 1. A volume of >40% of left ventricular scar measured by CMRI post-MI is predictive of LVEF less than 35% at 40 days and at 3 months 2. Volume scar as measured by Cardiac magnetic resonance imaging after AMI (at day 5) is predictive of clinical outcomes: SCD, total mortality, heart failure admission and life-threatening malignant ventricular arrhythmias regardless of ejection fraction at 40 days and at 3 months. Safety hypothesis: ICDs will be implanted if patients meet criteria at 40 days post MI as per the current American College of Cardiology (ACC) /American Heart Association (AHA) /Heart Rhythm Society (HRS) 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

NCT ID: NCT03715790 Completed - Clinical trials for Acute Myocardial Infarction

Improve SCA Bridge Study

Start date: November 2, 2018
Phase:
Study type: Observational

The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase (≥40-90 days post-acute MI).

NCT ID: NCT03714048 Completed - Hemorrhage Clinical Trials

Blood Management During ECMO for Cardiac Support

OBLEX
Start date: July 1, 2019
Phase:
Study type: Observational [Patient Registry]

Extracorporeal membrane oxygenation (ECMO) is a lifesaving procedure used to treat severe forms of heart and/or lung failure. It works by the principal of replacing the function of these organs by taking blood from the patient, provide it with oxygen outside the body and return it to the patient in one continuous circuit. Because of the evaluability of better technology, the use of ECMO has exponentially risen over the last decade. This treatment is very invasive and carries a number of risks. It is mostly used in situations where it seems likely that the patient would otherwise die and no other less invasive measure could change this. Still in large registries 50-60% of patients die which is often due to complications associated with the treatment. One of the most important complication is caused by the activation of clotting factors during the contact with the artificial surfaces of the device. This can lead to clot formation inside the patient or the device. To counterbalance this anticoagulation is needed. Because of the consumption of clotting factors and the heparin therapy bleeding complications are also very common in ECMO. Clinicians are challenged to balance these competing risks and are often forced to transfuse blood products to treat these conditions, which comes with additional risks for the patient. Many experienced centres have reported thromboembolic and bleeding events as the most important contributor to a poor outcome of this procedure. However, no international study combining the experience of multiple centres to compare their practice and identify risk factors which can be altered to reduce these risks. This study has been endorsed by the international ECMONet and aims to observe the practice in up to 50 centres and 500 patients worldwide to generate the largest ever published database on this topic. It will concentrate on patients with severe heart failure and will be able to identify specific risk factors for thromboembolic and bleeding events. Some of these factors may be modifiable by change in practice and can subsequently be evaluated in clinical trials. Some of these factors may include target values for heparin therapy and infusion of clotting factors. This study will directly improve patient management by informing clinicians which measures are associated with the best outcome and indirectly helps building trials to increase the evidence further.

NCT ID: NCT03642587 Completed - Clinical trials for Sudden Cardiac Death

Canadian Sudden Cardiac Arrest Network

C-SCAN
Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

The overall aim of the project is to develop a national registry to accurately measure the burden of Sudden Cardiac Arrest (SCA) among the general Canadian population. This project will create a common platform to link existing sources of information (EMS, Coroner and Administrative Databases) in order to fully understand the causes and outcomes of SCA. This comprehensive, unique registry will inform the progress and effectiveness of all CANet SCA programs aimed at reducing SCA. Understanding the antecedents, causes and outcomes of SCA will allow for new initiatives/investigations to reduce SCA, by using targeted interventions both effectively and efficiently.

NCT ID: NCT03526302 Completed - Clinical trials for Sudden Cardiac Death

TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation

TROPIC
Start date: April 1, 2018
Phase:
Study type: Observational

Serum Troponin levels pre- and postoperatively will be compared in patients receiving an entirely subcutaneous cardioverter-defibrillator.

NCT ID: NCT03504839 Completed - Cardiomyopathies Clinical Trials

Same Day Subcutaneous ICD And Send Home (DASH)

DASH
Start date: January 15, 2018
Phase: N/A
Study type: Interventional

Design: Prospective, non-randomized single center study at The Ohio State University Wexner Medical Center. Purpose: The purpose of this study is to prospectively evaluate a specific analgesia protocol designed to allow for same day discharge following implantation of the subcutaneous implantable cardiac defibrillator (S-ICD) Enrollment: Up to 40 subjects will be enrolled. Subject Population: Consecutive patients undergoing S-ICD implantation under general anesthesia or monitored anesthesia care. Endpoints: Rate of successful completion of the protocol; Procedural complications; Serial assessment of patient perception of pain.

NCT ID: NCT03387072 Completed - Clinical trials for Sudden Cardiac Death

CIQTP Prolongation : Role and Mechanism in Sudden Cardiac Death

IQARE-SCD
Start date: March 14, 2018
Phase:
Study type: Observational

Despite major progress in molecular and phenotypic characterization of primary electrical disorders, many (aborted) sudden cardiac deaths (SCD) occur in young victims without identifiable abnormalities. Investigator recently identified, in 4 families presenting unexplained SCD, a new arrhythmia entity (catecholamine-induced QT prolongation; CIQTP) characterized by normal QT duration at rest but major QT lengthening during mental stress test (MST). Investigators aim to determine the prevalence of this new phenotype in unexplained SCD and identify its underlying pathophysiological mechanism. More specifically, investigators aim to: - determine the prevalence of CIQTP in unexplained SCD and identify new affected families; - identify the role of mental stress in QT prolongation; - identify the genetics basis underlying this life threatening disease; - perform transcriptomic and electrophysiological profiling of induced pluripotent stem cell-derived cardiomyocytes (iPSC-CM) from CIQTP patients to identify putative biomarkers and pathophysiological mechanisms. MST will be performed, additionally to the conventional screening, in families affected by unexplained SCD or long QT syndrome (LQTS) referred to university hospitals of Nantes, Rennes, Tours and Brest. Relevance of the MST on the different type of LQTS will be evaluated and compared to conventional provocative tests (epinephrine, exercise). Whole-genome sequencing will first be performed in 3 distantly affected relatives within each of the 4 largest families identified. As previously performed in Nantes, analysis of the shared rare variants will allow identifying gene(s) associated with the disease. Transcriptomic (high-throughput 3' Digital Gene Expression mRNA sequencing) and electrophysiological (96-well automated optical recordings of action potentials and patch-clamp recordings of ionic currents, using specific ion channel activators and inhibitors) profiling will be performed on iPSC-CMs from 2 affected and one unaffected first-degree relatives of these 4 large families.

NCT ID: NCT03366181 Completed - Heart Failure Clinical Trials

Anti Arrhythmic Therapies and Sudden Cardiac Deaths

Start date: November 1, 2017
Phase:
Study type: Observational

Failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent sudden cardiac death (SCD). In this study we have prospectively investigated whether serum markers of heart failure (ultra sensitive Troponin , B type Natriuretic Peptide (BNP), C reactive protein (CRP), ST protein, and adiponectin could be used as predictors for the occurrence of malignant ventricular arrhythmias in patients who had received an Implantable Cardioverter Defibrillator (ICD) for primary prevention and treated by catheter ablation for ventricular arrhythmias.

NCT ID: NCT03319160 Completed - Clinical trials for Sudden Cardiac Death

LifeVest Safety and Efficacy in Real Life Settings in France

WEARIT France
Start date: February 2, 2017
Phase:
Study type: Observational [Patient Registry]

This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.

NCT ID: NCT03291145 Completed - Clinical trials for Sudden Cardiac Death

Exploring Mechanisms and Morphology of QT Interval Prolongation

TriQarr
Start date: June 27, 2017
Phase: N/A
Study type: Interventional

The projects will try and optimise the risk stratification for patients with Long QT syndrome by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics tested by "Brisk Standing". First, patients are tested with known arrhythmic triggers and they are then administered thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the patients are on Spironolactone for seven days. After seven days treatment the "Brisk Standing" is repeated.