scholarly journals Catch-up-ESUS - follow-up in embolic stroke of undetermined source (ESUS) in a prospective, open-label, observational study: study protocol and initial baseline data

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031716
Author(s):  
Katharina Feil ◽  
Johanna Heinrich ◽  
Clemens Küpper ◽  
Katharina Müller ◽  
Christoph Laub ◽  
...  
Keyword(s):  
Informed Consent ◽  
Treatment Algorithm ◽  
Embolic Stroke ◽  
Stroke Recurrence ◽  
Registry Study ◽  
Open Label ◽  
Catch Up ◽  
Written Informed Consent ◽  
Pfo Closure

IntroductionSo far there is no uniform, commonly accepted diagnostic and therapeutic algorithm for patients with embolic stroke of undetermined source (ESUS). Recent clinical trials on secondary stroke prevention in ESUS did not support the use of oral anticoagulation. As ESUS comprises heterogeneous subgroups including a wide age-range, concomitant patent foramen ovale (PFO), and variable probability for atrial fibrillation (AF), an individualised approach is urgently needed. This prospective registry study aims to provide initial data towards an individual, structured diagnostic and therapeutic approach in ESUS patients.Methods and analysisThe open-label, investigator-initiated, prospective, single-centre, observational registry study (Catch-up-ESUS) started in 01/2018. Consecutive ESUS patients ≥18 years who give informed consent are included and will be followed up for 3 years. Stratified by age <60 or ≥60 years, the patients are processed following a standardised diagnostic and treatment algorithm with an interdisciplinary design involving neurologists and cardiologists. Depending on the strata, patients receive a transesophageal echocardiogram; all patients receive an implantable cardiac monitor. Patients <60 years with PFO and without evidence of concomitant AF are planned for PFO closure within 6 months after stroke. The current diagnostic and therapeutic workup of ESUS patients requires improvement by both standardisation and a more individualised approach. Catch-up-ESUS will provide important data with respect to AF detection and PFO closure and will estimate stratified stroke recurrence rates after ESUS.Ethics and disseminationThe study has been approved by the responsible ethics committee at the Ludwig Maximilian University, Munich, Germany (project number 17–685). Catch-Up-ESUS is conducted in accordance with the Declaration of Helsinki. All patients will have to give written informed consent or, if unable to give consent themselves, their legal guardian will have to provide written informed consent for their participation. The first observation period of the registry study is 1 year, followed by the first publication of the results including follow-up of the patients. Further publications will be considered according the predefined individual follow-up dates of the stroke patients up to 36 months.Trial registration numberClinicaltrialsregister.gov registry (NCT03820375).

P5350Atrial fibrillation prediction using P wave signal-averaged ECG in patients with embolic stroke of undetermined source

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Shin ◽  
M Jung ◽  
J Song ◽  
J Kim ◽  
K Park ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Odds Ratio ◽  
Unknown Origin ◽  
Embolic Stroke ◽  
P Wave ◽  
Stroke Recurrence ◽  
Wave Duration ◽  
P Wave Duration ◽  
Potential Association

Abstract Background Approximately 10–25% of ischemic strokes are of unknown origin. Determining their potential association with subclinical atrial fibrillation (SCAF) is important for proper secondary prevention. We investigated whether SCAF can be predicted by assessing the atrial substrate with signal-averaged electrocardiography (SAECG). Methods Between April 2015 and February 2018, we recruited 125 consecutive patients with embolic stroke of undetermined source (ESUS) and 125 patients with paroxysmal atrial fibrillation (AF) patients as control. All participants underwent P wave SAECG at baseline and ESUS patients were followed up with ECG and Holter ECG, at baseline, 3, 6, and 12 months after discharge, and every 12 months thereafter. Results In the ESUS group (69 males, 68.4±12.1 years), 32 (25.6%) patients were diagnosed with SCAF during follow-up. There were no significant differences between both groups in terms of P wave duration [PWD] (ESUS vs. AF, P=0.321). PWD demonstrated a significant predictive efficacy for SCAF detection during follow-up (C-index of standard PWD=0.657, 95% confidence interval (CI) 0.552–0.761, P=0.008). Stroke recurrence occurred in 22 patients (17.6%) and was significantly associated with PWD but not SCAF (odds ratio 2.756, 95% CI 1.061–7.161, P=0.037). Conclusion PWD, an ECG biomarker associated with atrial substrate directly contributes to AF and ESUS, is useful for predicting SCAF. The potential for using this simple ECG biomarker for screening for SCAF amongst ESUS patients merits further exploration.

Abstract WMP110: Presence, Volume, and Location of New Ischemic Injury on MRI in Stroke Patients Who Undergo PFO Closure Compared to Patients Treated Medically: An Analysis of the REDUCE Trial

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Steven R Messe ◽  
Guray Erus ◽  
Michel Bilello ◽  
Christos Davatzikos ◽  
Grethe Andersen ◽  
...  
Keyword(s):  
Infarct Volume ◽  
Brain Infarction ◽  
Objective Measure ◽  
Open Label ◽  
Level Of Evidence ◽  
Ischemic Brain ◽  
Silent Brain Infarction ◽  
Silent Mri ◽  
Pfo Closure

Background: Randomized PFO closure trials have used open-label endpoint ascertainment, which may increase the risk of bias and undermine confidence in the conclusions. The Gore REDUCE Trial prospectively performed baseline and follow-up MRIs for all subjects, thereby providing an objective measure of the effectiveness of closure. Methods: The presence, location, and volume of new infarct, defined as an acute DWI lesion at time of recurrent clinical stroke or new lesion (>3mm) on T2/FLAIR from baseline to follow up MRI at 2 years, was evaluated using a semi-automated methodology blinded to treatment assignment, comparing patients randomized to undergo closure to those assigned medical therapy. Results: There were no differences in total new infarct volume, new large infarct (>3cm diameter), or new infarct location, comparing patients who underwent closure to those treated with medication (Table). New clinical stroke or clinically silent MRI infarct occurred in 18/383 (4.7%) patients who underwent closure and 19/177 (10.7%) of medically treated patients, RR 0.44, 95% CI 0.24-0.82, p=0.008. Recurrent clinical ischemic stroke occurred in 5/383 (1.3%) vs 12/177 (6.8%), RR 0.19, 95% CI 0.07-0.54, p=0.005, and silent brain infarction in 13/383 (3.3%) vs 7/177 (4.0%), RR 0.86, 95% CI 0.34-2.11, p=0.74. Conclusions: New MRI infarcts were generally small and the volumes and distribution of injury were similar between patients randomized to closure and those assigned to aspirin alone. The finding that silent infarcts were not smaller in volume than clinical ischemic strokes and that only clinical strokes were reduced by closure suggests that there may be ascertainment bias in clinical outcomes during open label studies. Nevertheless, as MRI is an objective outcome assessed blinded to randomization assignment, the REDUCE trial provides the highest level of evidence that PFO closure prevents recurrent ischemic brain injury, reducing new infarcts by more than half.

scholarly journals The Ethics and Legality of Using Personal Smartphones to take Medical Photographs

2019 ◽  
Vol 19 (2) ◽  
pp. 99
Author(s):  
Amal A. Al Balushi
Keyword(s):  
Informed Consent ◽  
Medical Profession ◽  
Medical Professional ◽  
Medical Professionals ◽  
High Quality ◽  
Medical Photography ◽  
Medical Legislation ◽  
Minimal Effort ◽  
Written Informed Consent

ABSTRACT: Photography in the medical profession is an asset that may help during patients’ follow-up, monitoring the progression of diseases, getting a second opinion and in medical educational activities. Advances in technology, specifically smartphones, have enabled medical professionals to obtain high-quality photographs with minimal effort and photography experience. This article discusses the ethics and legality of using personal smartphones in a medical professional setting for medical photography. Written informed consent should always be obtained from the patient and should include details about how the photographs will be used.Keywords: Photography; Smartphone; Informed Consent; Ethics; Medical Legislation; Publications; Medical Education; Oman.

Safety Comparison of Two Enterovirus 71 (EV71) Inactivated Vaccines in Yiwu, China

2019 ◽  
Vol 65 (6) ◽  
pp. 547-551 ◽  
Author(s):  
Shuying Luo ◽  
Fei Wu ◽  
Xiaojun Ye ◽  
Tao Fu ◽  
Jingbo Tao ◽  
...  
Keyword(s):  
Adverse Event ◽  
Informed Consent ◽  
Adverse Events ◽  
Enterovirus 71 ◽  
Dose Schedule ◽  
Significant Difference ◽  
Post Marketing ◽  
Inactivated Vaccines ◽  
Written Informed Consent

Abstract The safety of two kinds of post-marketing enterovirus 71 (EV71) vaccine in China was evaluated in this study. Fourteen vaccination clinics were randomly assigned in a 1:1 ratio, and both children in two groups were administered according to a two-dose schedule (on a 0 and 28 day schedule). Written informed consent was obtained, and recipients in this study were observed for 30 min after inoculation in the clinic, and then followed via phone or on-site follow-up at day 3 and 30. No severe EV71-associated adverse event was reported. No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556). There was no significant difference in the occurrence of adverse events among recipients aged less than 24 months; however, the proportion of adverse events was higher in Group CAMS than in Group Sinovac among the subjects aged 24–35 months (5.3% vs. 2.5%, p < 0.001). The two kinds of EV71 vaccines showed satisfactory safety. Adverse events after vaccination were normal and acceptable.

scholarly journals Usefulness of P Wave Duration in Embolic Stroke of Undetermined Source

2020 ◽  
Vol 9 (4) ◽  
pp. 1134
Author(s):  
Moonki Jung ◽  
Jin-Seok Kim ◽  
Ju Hyeon Song ◽  
Jeong-Min Kim ◽  
Kwang-Yeol Park ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Holter Monitoring ◽  
Embolic Stroke ◽  
P Wave ◽  
Stroke Recurrence ◽  
Wave Duration ◽  
P Wave Duration ◽  
Potential Association

The investigation of the potential association between ischemic stroke and subclinical atrial fibrillation (SCAF) is important for secondary prevention. We aimed to determine whether SCAF can be predicted by atrial substrate measurement with P wave signal-averaged electrocardiography (SAECG). We recruited 125 consecutive patients with embolic stroke of undetermined source (ESUS) and 125 patients with paroxysmal atrial fibrillation as controls. All participants underwent P wave SAECG at baseline, and patients with ESUS were followed up with Holter monitoring and electrocardiography at baseline, 3, 6, and 12 months after discharge and every 6 months thereafter. In the ESUS group, 32 (25.6%) patients were diagnosed with SCAF during follow-up. There were no significant differences between the groups regarding atrial substrate. P wave duration (PWD) was a significant predictor of SCAF. Stroke recurrence occurred in 22 patients (17.6%), and prolonged PWD (≥ 135 ms) predicted stroke recurrence more robustly than SCAF detection. In ESUS patients, PWD can be a useful biomarker to predict SCAF and to identify patients who are more likely to have a recurrent embolic stroke associated with an atrial cardiopathy. Further research is needed for supporting the utility and applicability of PWD.

Sign in / Sign up

Export Citation Format

Share Document