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Soluble C-type lectin-like receptor 2 in stroke (CLECSTRO) study: protocol of a multicentre, prospective cohort of a novel platelet activation marker in acute ischaemic stroke and transient ischaemic attack
This study was approved by the Ethical Committee of the University of Yamanashi as the central ethical committee in agreement with the ethical committees of all collaborative stroke centres. Informed consent will be obtained by an opt-out form from the patients at each stroke centre according to the Ethical Guidelines for Medical and Biological Research Involving Human Subjects by the Japanese Ministry of Health, Labour and Welfare. Trial registration numbers NCT05579405, UMIN000048954
Source: BMJ Open - September 18, 2023 Category: General Medicine Authors: Uchiyama, S., Suzuki-Inoue, K., Wada, H., Okada, Y., Hirano, T., Nagao, T., Kinouchi, H., Itabashi, R., Hoshino, H., Oki, K., Honma, Y., Ito, N., Sugimori, H., Kawamura, M. Tags: Open access, Diagnostics Source Type: research

Impact of areal socioeconomic status on prehospital delay of acute ischaemic stroke: retrospective cohort study from a prefecture-wide survey in Japan
Conclusions Living in socioeconomically disadvantaged municipalities was associated with prehospital delays of acute ischaemic stroke in non-capital areas in Kochi prefecture, Japan. Poorer outcomes of those patients may be caused by delayed treatment of intravenous rt-PA and endovascular reperfusion therapy. Further studies are necessary to determine social risk factors in the capital areas. Trial registration number This article is linked to a clinical trial to UMIN000050189, No.: R000057166 and relates to its Result stage.
Source: BMJ Open - August 24, 2023 Category: General Medicine Authors: Fukuda, H., Hyohdoh, Y., Ninomiya, H., Ueba, Y., Ohta, T., Kawanishi, Y., Kadota, T., Hamada, F., Fukui, N., Nonaka, M., Kawada, K., Fukuda, M., Nishimoto, Y., Matsushita, N., Nojima, Y., Kida, N., Hayashi, S., Izumidani, T., Nishimura, H., Moriki, A., Ue Tags: Open access, Neurology Source Type: research

National trends in the outcomes of subarachnoid haemorrhage and the prognostic influence of stroke centre capability in Japan: retrospective cohort study
Conclusions The 6-year trends indicated lower in-hospital mortality for patients with SAH (attributable to better outcomes), increased use of coiling and multidisciplinary care for untreated patients. Further increasing CSC capabilities may improve overall outcomes, mainly by increasing the use of coiling. Additional studies are necessary to determine the effect of confounders such as aneurysm complexity on outcomes of clipped patients in the modern endovascular era.
Source: BMJ Open - April 10, 2023 Category: General Medicine Authors: Kurogi, R., Kada, A., Ogasawara, K., Nishimura, K., Kitazono, T., Iwama, T., Matsumaru, Y., Sakai, N., Shiokawa, Y., Miyachi, S., Kuroda, S., Shimizu, H., Yoshimura, S., Osato, T., Horie, N., Nagata, I., Nozaki, K., Date, I., Hashimoto, Y., Hoshino, H., N Tags: Open access, Neurology 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

Incidence of stroke, systemic embolism and bleeding events in patients without anticoagulation based on real-world data in Japan: a retrospective cohort study
Conclusions Approximately one-third of the patients do not receive any anticoagulation in the modern DOAC era in Japan. The SSE rate increases by the CHADS2 score. The SSE rate is low in patients with a CHADS2 score <1, supporting no indication of anticoagulation in current guidelines. In patients with a CHADS2 score >1, the use of anticoagulant drug therapy is recommended because of a higher risk of stroke.
Source: BMJ Open - November 10, 2022 Category: General Medicine Authors: Tanizawa, K., Nishimura, Y., Sera, S., Yaguchi, D., Okada, A., Nishikawa, M., Tamaru, S., Nagai, N. Tags: Open access, Epidemiology Source Type: research

Risk of cardiovascular events leading to hospitalisation after Streptococcus pneumoniae infection: a retrospective cohort LIFE Study
Conclusions S. pneumoniae infections elevate the risk of subsequent stroke and AF occurrence. These findings indicate that pneumococcal infections have short-term effects on patients’ health and increase their midterm to long-term susceptibility to serious cardiovascular events.
Source: BMJ Open - November 4, 2022 Category: General Medicine Authors: Nishimura, N., Fukuda, H. Tags: Open access, Cardiovascular medicine Source Type: research

Cost-effectiveness of follow-up invasive coronary angiography after percutaneous coronary stenting: a real-world observational cohort study in Japan
Conclusions FUICA increased the costs but did not improve clinical benefits. Thus, FUICA is not economically more attractive than CF alone. Trial registration number UMIN000039768.
Source: BMJ Open - August 30, 2022 Category: General Medicine Authors: Shiina, T., Goto-Hirano, K., Takura, T., Daida, H. Tags: Open access, Health economics Source Type: research

Rationale and design of a prospective study evaluating population pharmacokinetics and pharmacodynamics of rivaroxaban in Chinese patients with non-valvular atrial fibrillation
Introduction Rivaroxaban is one of the most commonly used non-vitamin K antagonists for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Different individual exposures exist for Asian and non-Asian populations, and dose selection is different for Japanese and non-Japanese subjects. Few studies have investigated the pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in Chinese patients and provided a solid reference for dose selection and individualised therapy. Methods and analysis This is a single-centre prospective study. Rivaroxaban-treated Chinese NVAF patients will be recruited ...
Source: BMJ Open - June 3, 2022 Category: General Medicine Authors: Liu, X.-Q., Zhang, Y.-F., Ding, H.-Y., Yan, M.-M., Zhong, M.-K., Ma, C.-L. Tags: Open access, Pharmacology and therapeutics Source Type: research

Randomised placebo-controlled multicentre trial to evaluate the efficacy and safety of JTR-161, allogeneic human dental pulp stem cells, in patients with Acute Ischaemic stRoke (J-REPAIR)
Introduction JTR-161 is a novel allogeneic human cell product consisting of dental pulp stem cells isolated from the extracted teeth of healthy adults. It is currently under development as a cell-based therapy for ischaemic stroke. The aim of this study is to evaluate the safety and efficacy of JTR-161 in patients with acute ischaemic stroke when given as a single intravenous administration within 48 hours of symptom onset. Methods and analysis This is a first-in-human, randomised, double-blind, placebo-controlled, multicentre, phase 1/2 clinical trial to be conducted in Japan (from January 2019 to July 2021). Patients wi...
Source: BMJ Open - May 24, 2022 Category: General Medicine Authors: Suda, S., Nito, C., Ihara, M., Iguchi, Y., Urabe, T., Matsumaru, Y., Sakai, N., Kimura, K., on behalf of the J- REPAIR trial group, Okubo, Takeuchi, Takao, Takahashi, Morimoto, Akaiwa, Ishii, Kanzawa, Kanai, Yoshimura, Hara, Tsujino, Kamatsuka, Inoue, Iwa Tags: Open access, Neurology Source Type: research

Comparison of the effects on cardiovascular events between use of metformin and dipeptidyl peptidase-4 inhibitors as the first-line hypoglycaemic agents in Japanese patients with type 2 diabetes mellitus: a claims database analysis
Conclusions Patients who received metformin as first-line therapy may have reduced cardiovascular events than those receiving DPP-4i. This study conforms to previous Japanese database studies, despite the consideration of its limitation being an observational design.
Source: BMJ Open - March 11, 2022 Category: General Medicine Authors: Nishimura, R., Takeshima, T., Iwasaki, K., Aoi, S. Tags: Open access, Diabetes and Endocrinology Source Type: research

Randomised controlled trial to investigate optimal antithrombotic therapy in patients with non-valvular atrial fibrillation undergoing percutaneous coronary intervention: a study protocol of the OPTIMA-AF trial
This study received approval from the Certified Review Board of Osaka University (a certified research ethics committee by the Japanese Clinical Research Act). The findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number Japan Registry of Clinical Trials: jRCTs051190053; Pre-results.
Source: BMJ Open - December 14, 2021 Category: General Medicine Authors: Sotomi, Y., Kozuma, K., Kashiwabara, K., Higuchi, Y., Ando, K., Morino, Y., Ako, J., Tanabe, K., Muramatsu, T., Nakazawa, G., Hikoso, S., Sakata, Y., on behalf of the OPTIMA-AF Investigators Tags: Open access, Cardiovascular medicine Source Type: research

Effectiveness and safety of manual acupuncture therapy in patients with post-stroke depression: a protocol for a systematic review and meta-analysis
Introduction Acupuncture is widely used on the rehabilitation of stroke survivors, including hemiplegia, constipation, emotional disorders and so on. Although the effectiveness of manual acupuncture therapy on post-stroke depression (PSD) has been confirmed by multiple randomised controlled trials, there were few meta-analyses focused on the connection between different techniques, durations or other detailed operations of manual acupuncture and their effectiveness of improving the depression severity and quality of life for patients with PSD. Methods and analysis A systematic search will be performed on English databases...
Source: BMJ Open - December 10, 2021 Category: General Medicine Authors: Liu, W., Rao, C., Zhao, Q., Du, Y., Nan, X., Li, Z., Yin, C. Tags: Open access, Complementary medicine Source Type: research