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Cardiac Arrest clinical trials

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NCT ID: NCT02836340 Terminated - Cardiac Arrest Clinical Trials

TIBOHCA: Safety, Tolerability and Pharmacokinetics of 2-Iminobiotin (2-IB) After OHCA

TIBOHCA
Start date: May 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Following successful cardiopulmonary resuscitation (CPR) after out of hospital cardiac arrest (OHCA), 50% of patients admitted to the Intensive Care Unit (ICU) die. As most patients die due to brain damage sustained during cardiac arrest and the subsequent reperfusion phase, effective neuroprotective strategies could potentially improve outcome. In animal experiments, 2-Iminobiotin (2-IB), a selective neuronal and inducible nitric oxide synthase (NOS) inhibitor, given upon reperfusion has been shown to improve memory function. Since 2-IB has not shown any safety issues in preclinical and clinical studies. Before embarking on large studies with efficacy as primary endpoint, safety, tolerability and pharmacokinetics need to be established. Objective: Evaluate short term safety and tolerability, and the pharmacokinetic properties of 2-IB in adult patients after OHCA. Study design: Phase 2, single-centre, open-label, dose-escalation intervention study. Study population: Three cohorts of eight evaluable patients admitted to the ICU after OHCA due to a cardiac cause. Intervention: The first eight patients will receive 0,055 mg/kg 2-IB every 4 hours intravenously, 6 times in total (part A). The second eight patients (cohort B) will receive 0,165 mg/kg every 4h iv, 6 times in total. The third eight patients (cohort C) will receive 0,5 mg/kg every 4h iv, 6 times in total. Medication has to be given as soon as possible and within 6h after OHCA. Escalation to the next dose level will only be done after pharmacokinetic analyses have performed, no relevant safety issues have been encountered, and the DSMB approves to move to the next dose level. Main study parameters/endpoints: Study parameters to evaluate short term safety and tolerability will be vital signs (heart frequency, blood pressure, cardiac ischemia) before and until 15 minutes after administration. (Serious) Adverse Events will be recorded on the ICU (up to 7 days) or until discharge from the ICU. For evaluation of the pharmacokinetics profile of 2-IB, 9 plasma samples will be analysed. Secondary parameters: Biochemical markers Neuron specific Enolase and s100b at 24h and 48h after start of study drug, occurrence of SAEs until 30 days after OHCA including death, long term term efficacy as determined by the Cerebral Performance Category (CPC), the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) or the Telephone Interview Cognitive Status (TICS) scale at 30 days after OHCA.

NCT ID: NCT02611934 Terminated - Clinical trials for Acute Coronary Syndrome

Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With PCI

UNICORN
Start date: November 14, 2017
Phase: N/A
Study type: Interventional

Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated with better clinical outcomes as compared with therapy without MTH.

NCT ID: NCT02387398 Terminated - Cardiac Arrest Clinical Trials

Early Coronary Angiography Versus Delayed Coronary Angiography

PEARL
Start date: January 1, 2016
Phase: N/A
Study type: Interventional

This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac arrest patients without ST segment elevation. Safety will be assessed by evaluating the association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be assessed by a composite endpoint of improved left ventricular regional and global function (both regional wall motion analysis and left ventricular ejection fraction) as measured by echocardiography prior to hospital discharge and favourable neurological function (Cerebral Performance Categories 1 or 2) at discharge.

NCT ID: NCT02179060 Terminated - Cardiac Arrest Clinical Trials

Prehospital Resuscitation Intranasal Cooling Effects Seen in MRI of the Brain After Cardiac Arrest

COOLCAMRI
Start date: June 2014
Phase:
Study type: Observational

Therapeutic hypothermia improves the neurologically-intact survival rates in those patients resuscitated out-of-hospital from ventricular fibrillation. Cooling as early as possible might be beneficial to those victims. Diffusion Tensor Imaging and diffusion-weighted magnetic resonance imaging have recently shown to be able to identify early ischemia-related changes within the brain three days after cardiac arrest, among sudden cardiac arrest patients cooled in hospital. The physical changes seen within the brain may be able to distinguish survivors at very early phase. This study aims to assess early ischemia-related changes of the brain seen in MRI approximately three days after cardiac arrest. The hypotheses is that MRI will differ in the groups of patients treated with early intra-arrest cooling with the RhinoChill device and in hospital hypothermia in 36 Celsius, in the group of patients treated with normal in hospital hypothermia in 36 Celsius only, in the group of patients treated with normal in hospital hypothermia in 33 Celsius only (The historical Xenon study patients). The primary endpoint is the presence and pattern of white matter and gray matter degeneration and volumetric changes of the gray matter, white matter, and cerebro-spinal fluid spaces in MRI, and secondary endpoints are total survival at 90 days, and time to reach a target temperature (≤36/33 Celsius).

NCT ID: NCT02069353 Terminated - Cardiac Arrest Clinical Trials

Augmented Multimodal Neurologic Monitoring in High Risk Survivors of Cardiac Arrest

Start date: July 2015
Phase: N/A
Study type: Interventional

Cardiac arrest is the most common cause of death in the United States and as many as 590,000 Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to 89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain injury is the most common cause of death and disability after cardiac arrest. The investigators use advanced brain monitoring in patients who are at high risk of death after cardiac arrest, with the goal of preventing ongoing brain injury. The most common problem the investigators have observed is low oxygen levels in the brain, which is often very difficult to treat. In this study, the investigators plan to use two additional brain monitors in the care of these high risk patients: a monitor for seizures and a monitor of the amount of blood flow in the brain. The investigators will use these to detect and treat potential causes of low brain oxygen levels. The main hypotheses are that electrical events in the brain such as seizures and "spreading depolarizations" will occur during times of low brain tissue oxygen level, and that treating these events and low blood flow will reduce the rate of low brain oxygen levels.

NCT ID: NCT01718795 Terminated - Clinical trials for Cardiac Arrest During and/or Resulting From A Procedure

Prehospital Laryngeal Tube vs. Bag-Valve Mask Ventilation Used by Paramedics During CPR

Start date: September 2012
Phase: Phase 4
Study type: Interventional

During CPR bag-valve mask ventilation is difficult for basically skilled rescuers. Ventilation may be inefficient or with too high pressures result in stomach inflation and aspiration. Studies suggest that with a supraglottic airway device, such as the laryngeal tube, a basically skilled rescuer may ventilate more efficient and also safer. No prehospital study has been conducted comparing laryngeal tube and bag-valve mask ventilation during CPR. Thus, this study intends to compare ventilation with laryngeal tube and bag-valve mask performed by paramedics during CPR.

NCT ID: NCT01617291 Terminated - Cardiac Arrest Clinical Trials

Therapeutic Hypothermia After the Return of Spontaneous Circulation

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if induced therapeutic hypothermia (ITH) in the pre-hospital setting of a four county emergency medical system (EMS) that serves both urban and rural communities improves meaningful survival from medical cardiac arrest.

NCT ID: NCT01561144 Terminated - Cardiac Arrest Clinical Trials

UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic Implantable Cardiac Defibrillator Implant

UMBRELLA
Start date: August 2011
Phase: N/A
Study type: Observational

The purpose of the study is to analyze the different patient profiles implanted with an Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient prognosis as a function of clinical profile, implant indication, arrhythmias incidence, treatments or device programming.

NCT ID: NCT00472498 Terminated - Cardiac Arrest Clinical Trials

Comparison on the Efficacy of a Monophasic

AED
Start date: June 2005
Phase: N/A
Study type: Observational

The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.

NCT ID: NCT00457431 Terminated - Cardiac Arrest Clinical Trials

Hypothermia After In-hospital Cardiac Arrest

HACAinhospital
Start date: April 3, 2007
Phase: N/A
Study type: Interventional

ILCOR Recommendations "On the basis of the published evidence to date, the Advanced Life Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made the following recommendations in October 2002: Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest" (Circulation. 2003;108:118-121). This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest.