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Evaluation and management of patients with acute chest pain in China (EMPACT): protocol for a prospective, multicentre registry study.

ABSTRACT: INTRODUCTION:Acute chest pain represents a major healthcare burden in emergency departments (ED) throughout the world. Among these patients, rapidly determining whether an acute coronary syndrome (ACS) is evolving remains difficult. In China, there are limited data correlating the baseline characteristics, evaluation and management of ED patients with acute chest pain and ACS-related symptoms with clinical outcomes. Nor has there been an evaluation of outcomes at different levels of hospitals. The Evaluation and Management of Patients with Acute ChesT pain in China (EMPACT) study will address this evidence gap through a regional representative prospective registry. METHODS AND ANALYSIS:Twenty-two public hospitals with ED in Shandong province have been selected based on a stratified random sampling approach. A total of 10?000 patients with acute chest pain or suspected ACS presenting to the ED will be consecutively enrolled from January 2016 to September 2017. Episodes of care will be evaluated for key performance measures such as the time to first ECG, receipt of troponin testing, receipt of reperfusion therapy for ST segment elevation ACS and provision of angiography for troponin-positive patients. All patients will be assessed for the composite endpoint of adjudicated major adverse cardiac events in 30 days after presentation, including death from all causes, non-fatal myocardial infarction, urgent revascularisation, stroke, cardiac arrest and cardiogenic shock. The secondary outcomes include revisit to ED and rehospitalisation within 30 days. ETHICS AND DISSEMINATION:Ethics approval was obtained at all participating centres. The registry is the first attempt to comprehensively evaluate the current emergency care of acute chest pain from a regional representative sample in China. Findings will allow new opportunities to facilitate the clinical quality improvements and ultimately reduce the mortality in patients with acute chest pain and suspected ACS. TRIAL REGISTRATION NUMBER:NCT02536677; Pre-results.

SUBMITTER: Zheng W

PROVIDER: S-EPMC5786136 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Evaluation and management of patients with acute chest pain in China (EMPACT): protocol for a prospective, multicentre registry study.

Zheng Wen W Wang Jiali J Xu Feng F Zheng Jiaqi J Zhang He H Ma Jingjing J Wang Guangmei G Wang Hao H Chew Derek P DP Chen Yuguo Y

BMJ open 20180123 1

<h4>Introduction</h4>Acute chest pain represents a major healthcare burden in emergency departments (ED) throughout the world. Among these patients, rapidly determining whether an acute coronary syndrome (ACS) is evolving remains difficult. In China, there are limited data correlating the baseline characteristics, evaluation and management of ED patients with acute chest pain and ACS-related symptoms with clinical outcomes. Nor has there been an evaluation of outcomes at different levels of hosp ...[more]

PMID: 29362251

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Project description:IntroductionSevere ischaemic stroke is a devastating condition with high mortality and morbidity; however, there is insufficient evidence on its management. The aim of this study is to investigate causes, risk factors, clinical course, management and outcomes of severe ischaemic stroke in a real-world setting in tertiary hospitals in China.Methods and analysisThis is a prospective, multicentre, registry-based observational study. We will recruit 2500 patients with acute ischaemic stroke from nine tertiary hospitals in Western China. Patients with acute ischaemic stroke admitted to the Department of Neurology within 30 days of stroke onset will be included. Patients will be visited within 24 hours after admission, on day 3, day 7 and at discharge, to collect data on their clinical state, blood biomarkers and brain imaging. Severe stroke is defined as severe neurological deficits (National Institute of Health Stroke Scale (NIHSS) ≥15 or in coma) on admission or clinical worsening (NIHSS increased by ≥4 scores) during hospitalisation. Patients will be followed up by structured telephone interviews at 3 months and 1 year after stroke onset. In-hospital outcomes include symptomatic haemorrhagic transformation and brain oedema by day 7 of admission, and survival status (death or survival) by discharge; follow-up outcomes will include survival status and functional outcome (assessed by modified Rankin Scale) at 3 months and 1 year. The current study will improve our knowledge about the development of severe ischaemic stroke at acute phase and factors influencing its outcomes, which will eventually facilitate optimisation of individualised interventions for its prevention and treatment.Ethics and disseminationEthics approval is obtained from The Biomedical Research Ethics Committee of West China Hospital, Sichuan University (Reference No. 2017(130)). We will present our findings at the national and international conferences and peer-reviewed journals in stroke and neurology.Trial registration numberNCT03222024; Pre-results.

Project description:INTRODUCTION:Management of acute chest pain focuses on diagnosis or safe rule-out of an acute coronary syndrome (ACS). We aim to determine the additional value of self-reported computerised history taking (CHT). METHODS AND ANALYSIS:Prospective cohort study design with self-reported, medical histories collected by a CHT programme (Clinical Expert Operating System, CLEOS) using a tablet. Women and men presenting with acute chest pain to the emergency department at Danderyd University Hospital (Stockholm, Sweden) are eligible. CHT will be compared with standard history taking for completeness of data required to calculate ACS risk scores such as History, ECG, Age, Risk factors and Troponin (HEART), Global Registry of Acute Coronary Events (GRACE), and Thrombolysis in Myocardial Infarction (TIMI). Clinical outcomes will be extracted from hospital electronic health records and national registries. The CLEOS-Chest Pain Danderyd Study project includes (1) a feasibility study of CHT, (2) a validation study of CHT as compared with standard history taking, (3) a paired diagnostic accuracy study using data from CHT and established risk scores, (4) a clinical utility study to evaluate the impact of CHT on the management of chest pain and the use of resources, and (5) data mining, aiming to generate an improved risk score for ACS. Primary outcomes will be analysed after 1000 patients, but to allow for subgroup analysis, the study intends to recruit 2000 or more patients. This ongoing project may lead to new and more effective ways for collecting thorough, accurate medical histories with important implications for clinical practice. ETHICS AND DISSEMINATION:This study has been reviewed and approved by the Stockholm Regional Ethical Committee (now Swedish Ethical Review Authority). Results will be published, regardless of the outcome, in peer-reviewed international scientific journals. TRIAL REGISTRATION NUMBER:This study is registered at https://www.clinicaltrials.gov (unique identifier: NCT03439449).

Project description:BackgroundIt is unclear whether an evaluation incorporating coronary computed tomographic angiography (CCTA) is more effective than standard evaluation in the emergency department in patients with symptoms suggestive of acute coronary syndromes.MethodsIn this multicenter trial, we randomly assigned patients 40 to 74 years of age with symptoms suggestive of acute coronary syndromes but without ischemic electrocardiographic changes or an initial positive troponin test to early CCTA or to standard evaluation in the emergency department on weekdays during daylight hours between April 2010 and January 2012. The primary end point was length of stay in the hospital. Secondary end points included rates of discharge from the emergency department, major adverse cardiovascular events at 28 days, and cumulative costs. Safety end points were undetected acute coronary syndromes.ResultsThe rate of acute coronary syndromes among 1000 patients with a mean (±SD) age of 54±8 years (47% women) was 8%. After early CCTA, as compared with standard evaluation, the mean length of stay in the hospital was reduced by 7.6 hours (P<0.001) and more patients were discharged directly from the emergency department (47% vs. 12%, P<0.001). There were no undetected acute coronary syndromes and no significant differences in major adverse cardiovascular events at 28 days. After CCTA, there was more downstream testing and higher radiation exposure. The cumulative mean cost of care was similar in the CCTA group and the standard-evaluation group ($4,289 and $4,060, respectively; P=0.65).ConclusionsIn patients in the emergency department with symptoms suggestive of acute coronary syndromes, incorporating CCTA into a triage strategy improved the efficiency of clinical decision making, as compared with a standard evaluation in the emergency department, but it resulted in an increase in downstream testing and radiation exposure with no decrease in the overall costs of care. (Funded by the National Heart, Lung, and Blood Institute; ROMICAT-II ClinicalTrials.gov number, NCT01084239.).

Project description:Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the 'real clinical world'. Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full sternotomy; minimally invasive; or transcatheter; with both 'sutured' and 'sutureless' valves) will provide a 'real-world' picture of available results of current surgical options and will help to clarify the 'grey zones' of current guidelines.European Aortic Valve Registry is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery centres located in six countries (France, Germany, Italy, Spain, Switzerland and UK). Patients will be enrolled over a 2-year period and followed up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with Valve Academic Research Consortium-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing 'early' 30-day all-cause and cardiovascular mortality, as well as major morbidity, and 'late' cardiovascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results.The study protocol is approved by local ethics committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors for authorship.NCT03143361; Pre-results.

Project description:IntroductionCurrent evaluation of patients suspected of a non-ST-elevation acute coronary syndrome (NSTE-ACS) involves the use of algorithms that incorporate clinical information, electrocardiogram (ECG) and high-sensitivity cardiac troponins (hs-troponins). While primarily designed to rule out NSTE-ACS safely, these algorithms can also be used for rule in of NSTE-ACS in some patients. Still, in a substantial number of patients, these algorithms do not provide a conclusive work-up. These patients often present with an atypical clinical profile and low-range positive hs-troponin values without a characteristic rise or fall pattern. They represent a heterogeneous group of patients with various underlying conditions; only a fraction (30%-40%) will eventually be diagnosed with a myocardial infarction. Uncertainty exists about the optimal diagnostic strategy and their management depends on the clinical perspective of the treating physician ranging from direct discharge to admission for invasive coronary angiography. Coronary CT angiography (CCTA) is a non-invasive test that has been shown to be safe, fast and reliable in the evaluation of coronary artery disease. In this study, we will determine the usefulness of CCTA in patients with acute chest pain and low-range positive hs-troponin values.Methods and analysisA prospective, double-blind, observational, multicentre study conducted in the Netherlands. Patients aged 30-80 years presenting to the emergency department with acute chest pain and a suspicion of NSTE-ACS, a normal or non-diagnostic ECG and low-range positive hs-troponins will be scheduled to undergo CCTA. The primary outcome is the diagnostic accuracy of CCTA for the diagnosis of NSTE-ACS at discharge, in terms of sensitivity and negative predictive value.Ethics and disseminationThis study was approved by the Medical Research Ethics Committee of Erasmus Medical Center in Rotterdam, the Netherlands (registration number MEC-2017-506). Written informed consent to participate will be obtained from all participants. This study's findings will be published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov (NCT03129659).

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Dataset Information

Evaluation and management of patients with acute chest pain in China (EMPACT): protocol for a prospective, multicentre registry study.

Publications

Evaluation and management of patients with acute chest pain in China (EMPACT): protocol for a prospective, multicentre registry study.

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