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A protocol for a prospective observational study using chest and thumb ECG: transient ECG assessment in stroke evaluation (TEASE) in Sweden.

ABSTRACT: INTRODUCTION:Atrial fibrillation (AF) causes ischaemic stroke and based on risk factor evaluation warrants anticoagulation therapy. In stroke survivors, AF is typically detected with short-term ECG monitoring in the stroke unit. Prolonged continuous ECG monitoring requires substantial resources while insertable cardiac monitors are invasive and costly. Chest and thumb ECG could provide an alternative for AF detection poststroke.The primary objective of our study is to assess the incidence of newly diagnosed AF during 28 days of chest and thumb ECG monitoring in cryptogenic stroke. Secondary objectives are to assess health-related quality of life (HRQoL) using short-form health survey (SF-36) and the feasibility of the Coala Heart Monitor in patients who had a stroke. METHODS:Stroke survivors in Region Gävleborg, Sweden, will be eligible for the study from October 2017. Patients with a history of ischaemic stroke without documented AF before or during ECG evaluation in the stroke unit will be evaluated by the chest and thumb ECG system Coala Heart Monitor. The monitoring system is connected to a smartphone application which allows for remote monitoring and prompt advice on clinical management. Over a period of 28 days, patients will be monitored two times a day and may activate the ECG recording at symptoms. On completion, the system is returned by mail. This system offers a possibility to evaluate the presence of AF poststroke, but the feasibility of this system in patients who recently suffered from a stroke is unknown. In addition, HRQoL using SF-36 in comparison to Swedish population norms will be assessed. The feasibility of the Coala Heart Monitor will be assessed by a self-developed questionnaire. ETHICS AND DISSEMINATION:The study was approved by The Regional Ethical Committee in Uppsala (2017/321). The database will be closed after the last follow-up, followed by statistical analyses, interpretation of results and dissemination to a scientific journal. TRIAL REGISTRATION NUMBER:NCT03301662; Pre-results.

SUBMITTER: Magnusson P

PROVIDER: S-EPMC5892735 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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A protocol for a prospective observational study using chest and thumb ECG: transient ECG assessment in stroke evaluation (TEASE) in Sweden.

Magnusson Peter P Koyi Hirsh H Mattsson Gustav G

BMJ open 20180403 4

<h4>Introduction</h4>Atrial fibrillation (AF) causes ischaemic stroke and based on risk factor evaluation warrants anticoagulation therapy. In stroke survivors, AF is typically detected with short-term ECG monitoring in the stroke unit. Prolonged continuous ECG monitoring requires substantial resources while insertable cardiac monitors are invasive and costly. Chest and thumb ECG could provide an alternative for AF detection poststroke.The primary objective of our study is to assess the incidenc ...[more]

PMID: 29615448

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Project description:ObjectivesThe aim of this study was to assess the feasibility, based on a questionnaire, of the chest and thumb ECG system Coala Heart Monitor in patients who recently had a stroke.DesignObservational study.SettingTwo stroke units, Region Gävleborg, Sweden.Participants and interventionsThis study, Transient ECG Assessment in Stroke Evaluation (TEASE), included patients who had a stroke between 2017 and 2019. Patients eligible for anticoagulation in the presence of atrial fibrillation were scheduled for 28 days monitoring.Primary and secondary outcome measuresThe questionnaire regarding feasibility of monitoring included seven questions, using a 100 mm Visual Analogue Scale which covered overall satisfaction, technical feasibility, remember to monitor, physical application, feeling of security, help from others and recommendation to others. A lower score indicated better outcome.ResultsThe prespecified number of 100 patients underwent the monitoring and 83 out of the 97 alive patients returned the questionnaire (response rate 85.6%). The median age was 69.5 years, mean CHA2DS2-VASc score was 4.4±1.3 points and 59.0% were men (n=49). The median time from index stroke to start of monitoring was 7.0 days. Patients performed on average 90.1%±15.0% of scheduled ECG-transmissions. In all seven questions, the median score ranged from 4 to 8. The vast majority reported acceptable outcomes, that is, the 95th percentile ranged from 30 to 54. There was no significant difference between men and women with regard to any of the seven questions (p values ranging from 0.117 to 0.849). Two of the seven outcome scores correlated significantly to patient age (Spearman's r=-0.238 and r=-0.308, and p values 0.031 and 0.005 for 'overall satisfaction' and 'remember to monitor', respectively).ConclusionIn stroke survivors, chest and thumb ECG two times per day over a period of 4 weeks is feasible from a patient's perspective. The Coala Heart Monitor provides a valuable and convenient tool for monitoring after stroke.Trial registration numberNCT03301662.

Project description:Levels of the cardiac muscle regulatory protein troponin T (cTnT) are frequently elevated in patients with acute ischemic stroke and elevated cTnT predicts poor outcome and mortality. The pathomechanism of troponin release may relate to co-morbid coronary artery disease and myocardial ischemia or, alternatively, to neurogenic cardiac damage due to autonomic activation after acute ischemic stroke. Therefore, there is uncertainty about how acute ischemic stroke patients with increased cTnT levels should be managed regarding diagnostic and therapeutic workup.The primary objective of the prospective observational trial TRELAS (TRoponin ELevation in Acute ischemic Stroke) is to investigate the frequency and underlying pathomechanism of cTnT elevation in acute ischemic stroke patients in order to give guidance for clinical practice. All consecutive patients with acute ischemic stroke admitted within 72 hours after symptom onset to the Department of Neurology at the Campus Benjamin Franklin of the University Hospital Charité will be screened for cTnT elevations (i.e. ? 0.05 ?g/l) on admission and again on the following day. Patients with increased cTnT will undergo coronary angiography within 72 hours. Diagnostic findings of coronary angiograms will be compared with age- and gender-matched patients presenting with Non-ST-Elevation myocardial infarction to the Department of Cardiology. The primary endpoint of the study will be the occurrence of culprit lesions in the coronary angiogram indicating underlying co-morbid obstructive coronary artery disease. Secondary endpoints will be the localization of stroke in the cerebral imaging and left ventriculographic findings of wall motion abnormalities suggestive of stroke-induced global cardiac dysfunction.TRELAS will prospectively determine the frequency and possible etiology of troponin elevation in a large cohort of ischemic stroke patients. The findings are expected to contribute to clarify pathophysiologic concepts of co-morbid cardiac damage in ischemic stroke patients and also to provide a basis for clinical recommendations for cardiac workup of such patients.clinicaltrials.gov NCT01263964.

Project description:BackgroundElevated cardiac troponin, which indicates cardiomyocyte injury, is common after acute ischemic stroke and is associated with poor functional outcome. Myocardial injury is part of a broad spectrum of cardiac complications that may occur after acute ischemic stroke. Previous studies have shown that in most patients, the underlying mechanism of stroke-associated myocardial injury may not be a concomitant acute coronary syndrome. Evidence from animal research and clinical and neuroimaging studies suggest that functional and structural alterations in the central autonomic network leading to stress-mediated neurocardiogenic injury may be a key underlying mechanism (ie, stroke-heart syndrome). However, the exact pathophysiological cascade remains unclear, and the diagnostic and therapeutic implications are unknown.ObjectiveThe aim of this CORONA-IS (Cardiomyocyte injury following Acute Ischemic Stroke) study is to quantify autonomic dysfunction and to decipher downstream cardiac mechanisms leading to myocardial injury after acute ischemic stroke.MethodsIn this prospective, observational, single-center cohort study, 300 patients with acute ischemic stroke, confirmed via cerebral magnetic resonance imaging (MRI) and presenting within 48 hours of symptom onset, will be recruited during in-hospital stay. On the basis of high-sensitivity cardiac troponin levels and corresponding to the fourth universal definition of myocardial infarction, 3 groups are defined (ie, no myocardial injury [no cardiac troponin elevation], chronic myocardial injury [stable elevation], and acute myocardial injury [dynamic rise/fall pattern]). Each group will include approximately 100 patients. Study patients will receive routine diagnostic care. In addition, they will receive 3 Tesla cardiovascular MRI and transthoracic echocardiography within 5 days of symptom onset to provide myocardial tissue characterization and assess cardiac function, 20-min high-resolution electrocardiogram for analysis of cardiac autonomic function, and extensive biobanking. A follow-up for cardiovascular events will be conducted 3 and 12 months after inclusion.ResultsAfter a 4-month pilot phase, recruitment began in April 2019. We estimate a recruitment period of approximately 3 years to include 300 patients with a complete cardiovascular MRI protocol.ConclusionsStroke-associated myocardial injury is a common and relevant complication. Our study has the potential to provide a better mechanistic understanding of heart and brain interactions in the setting of acute stroke. Thus, it is essential to develop algorithms for recognizing patients at risk and to refine diagnostic and therapeutic procedures.Trial registrationClinicaltrials.gov NCT03892226; https://www.clinicaltrials.gov/ct2/show/NCT03892226.International registered report identifier (irrid)DERR1-10.2196/24186.

Project description:IntroductionThe efficacy of both intravenous treatment (IVT) and endovascular treatment (EVT) for patients with acute ischaemic stroke strongly declines over time. Only a subset of patients with ischaemic stroke caused by an intracranial large vessel occlusion (LVO) in the anterior circulation can benefit from EVT. Several prehospital stroke scales were developed to identify patients that are likely to have an LVO, which could allow for direct transportation of EVT eligible patients to an endovascular-capable centre without delaying IVT for the other patients. We aim to prospectively validate these prehospital stroke scales simultaneously to assess their accuracy in predicting LVO in the prehospital setting.Methods and analysisPrehospital triage of patients with suspected stroke symptoms (PRESTO) is a prospective multicentre observational cohort study in the southwest of the Netherlands including adult patients with suspected stroke in the ambulance. The paramedic will assess a combination of items from five prehospital stroke scales, without changing the normal workflow. Primary outcome is the clinical diagnosis of an acute ischaemic stroke with an intracranial LVO in the anterior circulation. Additional hospital data concerning the diagnosis and provided treatment will be collected by chart review. Logistic regression analysis will be performed, and performance of the prehospital stroke scales will be expressed as sensitivity, specificity and area under the receiver operator curve.Ethics and disseminationThe Institutional Review Board of the Erasmus MC University Medical Centre has reviewed the study protocol and confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) is not applicable. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations. The best performing scale, or the simplest scale in case of clinical equipoise, will be integrated in a decision model with other clinical characteristics and real-life driving times to improve prehospital triage of suspected stroke patients.Trial registration numberNTR7595.

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).

Project description:BackgroundThe two-thumb encircling technique (2TT) is superior to the two-finger technique (2FT) in infant cardiopulmonary resuscitation (CPR), but there are difficulties in providing ventilation as soon as possible. We modified the 2TT to the cross-thumb technique (CTT) to maintain good CPR performance at the same position as 2FT. We aimed to compare the quality of chest compression and brief hands-off times in 2FT, 2TT, and CTT by a single rescuer using an infant CPR manikin model.MethodsThis study was designed as a prospective randomized controlled simulation-based study. We used the Resusci® Baby QCPR (Laerdal Medical, Stavanger, Norway) as a simulated 3-month-old infant. Ventilation was performed by the mouth-to-mouth technique using a chest compression-to-ventilation ratio of 30:2 as a single rescuer. Data on CPR quality, such as locations, rates, depth and release of chest compressions, hands-off times, and proper ventilation, were recorded using the Resusci® Baby QCPR and SkillReporter. Also, the chest compression fraction (CCF) was automatically calculated.ResultsThe depth of chest compression in 2FT, 2TT, and CTT were 40.0 mm (interquartile range [IQR] 39.0, 41.0), 42.0 mm (IQR 41.0, 43.0), and 42.0 mm (IQR 41.0, 43.0), respectively. The depth of chest compression in 2FT was shallower than that in the other two techniques (P<0.05). CCF in 2FT, 2TT, and CTT were 73.9% (IQR 72.2, 75.6), 71.2% (IQR 67.2, 72.2) and 71.3% (IQR 67.7, 74.1), respectively. CCF was higher in 2FT than in the other two techniques (P<0.05). Correct location in 2FT, 2TT, and CTT were 99.0% (IQR 86.0, 100.0), 100.0% (IQR 97.0, 100.0) and 100.0% (IQR 99.0, 100.0), respectively. Correct location in CTT and 2TT was higher than that in 2FT. Performing CTT, the subjective pain and fatigue score were lower than other two technique.ConclusionA new chest compression technique, CTT was better in chest compression depth compared with 2FT and may be helpful in maintaining correct chest compression location with less pain and fatigue in infant CPR.

Dataset Information

A protocol for a prospective observational study using chest and thumb ECG: transient ECG assessment in stroke evaluation (TEASE) in Sweden.

Publications

A protocol for a prospective observational study using chest and thumb ECG: transient ECG assessment in stroke evaluation (TEASE) in Sweden.

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