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Source: BMJ Open
Condition: Ischemic Stroke
Management: Hospitals

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Total 33 results found since Jan 2013.

Efficacy and safety of carbon dioxide insufflation for brain protection for patients undergoing planned left-sided open heart valve surgery: protocol for a multicentre, placebo-controlled, blinded, randomised controlled trial (the CO2 Study)
Introduction Brain injury is common following open heart valve surgery. Carbon dioxide insufflation (CDI) has been proposed to reduce the incidence of brain injury by reducing the number of air microemboli entering the bloodstream in surgery. The CO2 Study will evaluate the efficacy and safety of CDI in patients undergoing planned left-sided open heart valve surgery. Methods and analysis The CO2 Study is a multicentre, blinded, placebo-controlled, randomised controlled trial. Seven-hundred and four patients aged 50 years and over undergoing planned left-sided heart valve surgery will be recruited to the study, from at lea...
Source: BMJ Open - May 17, 2023 Category: General Medicine Authors: Todd, R., Rogers, C. A., Pufulete, M., Culliford, L., Pretorius, P., Voets, N., Akowuah, E., Sayeed, R., Lazaroo, M., Kaur, S., Angelini, G. D., Gibbison, B. Tags: Open access, Surgery Source Type: research

Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal trial
This study was approved by the Ethics Committee of the Local Health Unit of Matosinhos (Ref. 75/CES/JAS). Written informed consent will be required from all the participants; data protection and confidentiality will be also ensured. The findings of this project are expected to be submitted for publication in scientific articles, and the main results will be presented at relevant scientific meetings. Trial registration number NCT05369637.
Source: BMJ Open - April 28, 2023 Category: General Medicine Authors: Goncalves, M., Lima, M. J., Fonseca, A., Duque, C., Costa, A. R., Cruz, V. T. Tags: Open access, Neurology Source Type: research

Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic randomised clinical trial. DiVa (Dijon vascular) study
We describe the protocol of a randomised clinical trial that aims to evaluate the efficiency and effectiveness of an intensive multidisciplinary follow-up of patients compared with standard care. Methods and analysis The DiVa study is a randomised, prospective, controlled, multicentre trial including patients >18 years old with a first or recurrent stroke (ischaemic or haemorrhagic) or TIA, or a type I or II MI, managed in one of the participating hospitals of the study area, with a survival expectancy >12 months. Patients will be randomised with an allocation ratio of 1:1 in two parallel groups: one group assigned ...
Source: BMJ Open - April 26, 2023 Category: General Medicine Authors: Bejot, Y., Soilly, A.-L., Bardou, M., Duloquin, G., Pommier, T., Laurent, G., Cottin, Y., Vadot, L., Adam, H., Boulin, M., Giroud, M. Tags: Open access, Cardiovascular medicine Source Type: research

Registry for Evaluating Healthy Life Expectancy and Long-Term Outcomes after Catheter Ablation of Atrial Fibrillation in the Very Elderly (REHEALTH AF) study: rationale and design of a prospective, multicentre, observational, comparative study
Introduction Data are lacking on the extent to which patients with non-valvular atrial fibrillation (AF) who are aged ≥80 years benefit from ablation treatment. The question pertains especially to patients’ postablation quality of life (QoL) and long-term clinical outcomes. Methods and analysis We are initiating a prospective, registry-based, multicentre observational study that will include patients aged ≥80 years with non-valvular AF who choose to undergo treatment by catheter ablation and, for comparison, such patients who do not choose to undergo ablation (either according to their physician’s advice...
Source: BMJ Open - February 15, 2023 Category: General Medicine Authors: Okumura, Y., Nagashima, K., Watanabe, R., Yokoyama, K., Kato, T., Fukaya, H., Hayashi, H., Nakahara, S., Shimizu, W., Iwasaki, Y.-k., Fujimoto, Y., Mukai, Y., Ejima, K., Otsuka, T., Suzuki, S., Murakami, M., Kimura, M., Harada, M., Koyama, J., Okamatsu, H Tags: Open access, Cardiovascular medicine Source Type: research

New device multisegment Mechanical Thrombectomy System for endovascular treatment in acute ischaemic stroke: study protocol for a prospective, multicentre, randomised controlled trial
Introduction Endovascular treatment is the standard of care for acute large vessel occlusion (LVO) in the anterior circulation. However, successful complete recanalisation is considerably difficult when the vessels are severely tortuous. At the bend, the stent retriever can distort, collapse and lose its ability to capture the clot due to structural change. The aim of the present study is to evaluate the safety and efficacy of the new thrombectomy device multisegment Mechanical Thrombectomy (MT) System for endovascular treatment of acute ischaemic stroke (AIS). Methods and analysis The present study is a prospective, mult...
Source: BMJ Open - November 16, 2022 Category: General Medicine Authors: Zhong, H., Li, Z., Zhou, T., Li, T., He, Y. Tags: Open access, Neurology Source Type: research

Multicentre registration of wake-up stroke in China (MCRWUSC): a protocol for a prospective, multicentre, registry-based cohort study
This study is approved by the ethics committee of Shanghai Pudong Hospital (Shanghai, China) and rest of all participating centres. The findings will be disseminated through peer-reviewed publications and conference presentations. PROSPERO registration number ChiCTR2100049133.
Source: BMJ Open - November 10, 2022 Category: General Medicine Authors: Zhang, Z., Yang, H., Tu, Z., Nepal, G., Ojha, R., Xi, Y., Qiao, J., Hu, M., Li, C., Lin, F., Zhou, L., Jin, P., Hou, S. Tags: Open access, Neurology Source Type: research

Efficacy and safety of human-derived neural stem cell in patients with ischaemic stroke: study protocol for a randomised controlled trial
Introduction Stroke is the most common cause of neurological disability in adults worldwide. Neural stem cell (NSC) transplantation has shown promising results as a treatment for stroke in animal experiments. The pilot investigation of stem cells in stroke phase 1 and phase 2 trials showed that transplantation of the highest dose (20 million cells) was well tolerated. Preliminary clinical benefits have also been observed. However, the trials were open-label and had a small sample size. Furthermore, human NSCs (hNSCs) were intracerebrally implanted, and some serious adverse events were considered to be related to the surgic...
Source: BMJ Open - November 8, 2022 Category: General Medicine Authors: Xie, C., Wang, K., Peng, J., Jiang, X., Pan, S., Wang, L., Wu, Y., Guan, Y. Tags: Open access, Neurology Source Type: research

Mechanical thrombectomy first versus direct angioplasty or stenting for the treatment of intracranial atherosclerotic stenosis-related large vessel occlusion: protocol for a systematic review and meta-analysis
This study seeks to provide direct and practical clinical evidence for clinicians. Methods and analysis The main databases of PubMed, the Cochrane library, Embase and Web of Science will be screened for related studies published after1 January 2015. Primary outcomes include successful recanalisation and 90-day favourable outcome. Secondary outcomes include puncture to revascularisation time, vascular complication (perforation, dissection and vasospasm), intracerebral haemorrhage, hospital-related complications and 90-day mortality. The Newcastle-Ottawa Scale will be adopted to assess risk bias of observational studies. Th...
Source: BMJ Open - October 31, 2022 Category: General Medicine Authors: Min, X., Li, W., Zhao, H., Chen, Q., Zheng, J., Zhao, X., Zhao, Q., Bai, X., Dmytriw, A. A., Patel, A. B., Feng, Y., Cao, W., Wang, X., Jiao, L. Tags: Open access, Neurology Source Type: research

Stroke prevention of thoracoscopic left atrial appendage clipping in patients with non-valvular atrial fibrillation at high risk of stroke and bleeding: study protocol for a non-randomised controlled clinical trial
Introduction Non-valvular atrial fibrillation (NVAF) is a high-risk factor for ischaemic stroke. The 2016 European Society of Cardiology Atrial Fibrillation Management guidelines recommend oral anticoagulants (OACs) to prevent stroke in men with CHA2DS2-VASc scores ≥2 and women ≥3. However, in patients with a high risk of stroke and a high risk of bleeding (HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly (> 65 years), Drugs/alcohol concomitantly) score≥3), OAC had a higher risk of bleeding. Left atrial appendage cl...
Source: BMJ Open - October 28, 2022 Category: General Medicine Authors: Ye, C., Han, X., Chen, Y., Liu, F., Ma, H., Yang, Y., Liu, Y., Hu, Q., Yao, Q., Xie, W., Xu, D. Tags: Open access, Surgery Source Type: research

Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER): protocol for a prospective observational nationwide study
Introduction Atrial fibrillation (AF) is a prevalent disease considerably contributing to the worldwide cardiovascular burden. For patients at high thromboembolic risk (CHA2DS2-VASc ≥3) and not suitable for chronic oral anticoagulation, owing to history of major bleeding or other contraindications, left atrial appendage occlusion (LAAO) is indicated for stroke prevention, as it lowers patient’s ischaemic burden without augmentation in their anticoagulation profile. Methods and analysis Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (S...
Source: BMJ Open - September 21, 2022 Category: General Medicine Authors: Kowalewski, M., Wanha, W., Litwinowicz, R., Kołodziejczak, M., Pasierski, M., Januszek, R., Kuzma, Łukasz, Grygier, M., Lesiak, M., Kapłon-Cieslicka, A., Reczuch, K., Gil, R., Pawłowski, T., Bartus, K., Dobrzycki, S., Lorusso, Tags: Open access, Cardiovascular medicine Source Type: research

Health economic evaluation of the 'Flying Intervention Team as a novel stroke care concept for rural areas: study protocol of the TEMPiS-GÖA study
The objective of the present paper is to describe the methods for the economic evaluation (TEMPiS-Gesundheitsökonomische Analyse (TEMPiS-GÖA)) alongside the TEMPiS-FIT study to determine whether the new form of care is cost-effective compared with standard care. Methods and analysis The within-trial cost-effectiveness analysis (CEA) and cost–utility analysis (CUA) will be performed from a statutory health insurance perspective as well as from a societal perspective over the time horizon of 12 months after the patients’ hospital discharge. Direct costs from outpatient and inpatient care are coll...
Source: BMJ Open - September 20, 2022 Category: General Medicine Authors: Coors, M., Flemming, R., Schüttig, W., Hubert, G. J., Hubert, N. D., Sundmacher, L. Tags: Open access, Health economics Source Type: research

Protocol for Home-Based Solution for Remote Atrial Fibrillation Screening to Prevent Recurrence Stroke (HUA-TUO AF Trial): a randomised controlled trial
The objective of the study was to explore the use of long-term home-based ECG monitoring for AF detection and stroke prevention in patients with a history of stroke. Methods and analysis This prospective, randomised, open-label trial with blinded endpoint adjudication aimed to evaluate the efficacy of long-term home-based ECG monitoring for AF detection and stroke prevention in a 24-month period. Patients aged >18 years with a history of ischaemic stroke will be stratified according to the time from the index ischaemic stroke: <1, 1–3 and >3 years and then randomised in 1:1 to (1) home-based AF screening an...
Source: BMJ Open - July 15, 2022 Category: General Medicine Authors: Wong, C. K., Hai, J. J., Lau, Y.-M., Zhou, M., LUI, H.-W., Lau, K. K., Chan, K.-H., Mok, T. M., Liu, Y., Feng, Y., Tan, N., Tam, W.-C., Tam, K.-C., Feng, X., Zuo, M.-L., Yin, L.-X., Tan, J., Zhang, W.-J., Jiang, X., Huang, X., Ye, J., Liang, Y., Jiang, W. Tags: Open access, Cardiovascular medicine Source Type: research

Structured follow-up pathway to support people after transient ischaemic attack and minor stroke (SUPPORT TIA): protocol for a feasibility study and process evaluation
Introduction People who experience transient ischaemic attack (TIA) and minor stroke have limited follow-up despite rapid specialist review in hospital. This means they often have unmet needs and feel abandoned following discharge. Care needs after TIA/minor stroke include information provision (diagnosis and stroke risk), stroke prevention (medication and lifestyle change) and holistic care (residual problems and return to work or usual activities). This protocol describes a feasibility study and process evaluation of an intervention to support people after TIA/minor stroke. The study aims to assess the feasibility and ac...
Source: BMJ Open - June 16, 2022 Category: General Medicine Authors: Turner, G. M., Jones, R., Collis, P., Patel, S., Jowett, S., Tearne, S., Foy, R., Atkins, L., Mant, J., Calvert, M. Tags: Open access, Cardiovascular medicine Source Type: research

Multicentre collection of uniform data on patients hospitalised for transient ischaemic attack or stroke in the Philippines: the Philippine Neurological Association One Database-Stroke (PNA1DB-Stroke) protocol
Introduction For scientific advances to translate into improved patient outcomes, systems of care must be in place to facilitate delivery of care. There is scarce information on quality of care and clinical outcome in our stroke patients. We aim to collect uniform data from patients with first or recurrent transient ischaemic attack (TIA) or ischaemic or haemorrhagic stroke to determine in-patient caseload, patient profile, types of diagnostic and therapeutic procedures, outcomes and overall quality of care among patients hospitalised for acute stroke in the Philippines. Methods and analysis This multicentre observational...
Source: BMJ Open - May 24, 2022 Category: General Medicine Authors: Philippine Neurological Association One Database - Stroke, Disease Study Management Group, Gan, Alvarez, Canete, Co, Collantes, Escabillas, Hiyadan, Juangco, Lokin, Macrohon-Valdez, Punsalan, Sarapuddin, Picar, Pascual V Tags: Open access, Neurology Source Type: research

Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance (Mobile Stroke Unit--TASTE-A): protocol for a prospective randomised, open-label, blinded endpoint, phase II superiority trial of tenecteplase versus alteplase for ischaemic stroke patients presenting within 4.5 hours of symptom onset to the mobile stroke unit
Introduction Mobile stroke units (MSUs) equipped with a CT scanner are increasingly being used to assess and treat stroke patients’ prehospital with thrombolysis and transfer them to the most appropriate hospital for ongoing stroke care and thrombectomy when indicated. The effect of MSUs in both reducing the time to reperfusion treatment and improving patient outcomes is now established. There is now an opportunity to improve the efficacy of treatment provided by the MSU. Tenecteplase is a potent plasminogen activator, which may have benefits over the standard of care stroke lytic alteplase. Specifically, in the MSU ...
Source: BMJ Open - April 29, 2022 Category: General Medicine Authors: Bivard, A., Zhao, H., Coote, S., Campbell, B., Churilov, L., Yassi, N., Yan, B., Valente, M., Sharobeam, A., Balabanski, A., Dos Santos, A., Ng, F., Langenberg, F., Stephenson, M., Smith, K., Bernard, S., Thijs, V., Cloud, G., Choi, P., Ma, H., Wijeratne, Tags: Open access, Neurology Source Type: research