
Sleep, Small Vessel Disease, and Cognition in Minor Stroke
METHODOLOGY:
This cross-sectional study analysed 422 patients with TIA or mild stroke from two prospective cohorts (Edinburgh-UK, n = 211 and Hong Kong, n = 211) between 2018 and 2022, with all participants assessed at 1-3 months post-stroke.
Participants underwent brain MRI for assessing markers of SVD (Fazekas white matter hyperintensities [WMHs], lacunes, perivascular spaces, and microbleeds) and the Montreal Cognitive Assessment (MoCA) for evaluating cognition.
Self-reported sleep metrics (in-bed time, nighttime sleep duration, sleep latency, and sleep efficiency) were extracted from an adapted Pittsburgh Sleep Quality Index.
The main outcome was SVD burden; the secondary outcome was the total MoCA score.
TAKEAWAY:
Longer in-bed time was independently associated with increased summary SVD burden (odds ratio [OR], 1.27 per 1-SD increase; false discovery rate-adjusted P = .04) and greater periventricular burden (OR, 1.53 per 1-SD increase; P = .003).
= .04) and greater periventricular burden (OR, 1.53 per 1-SD increase; = .003). Increased sleep duration was not associated with cognitive performance/longer in-bed time was significantly associated with a lower total MoCA score (standardised β, −0.58; P = .02).
= .02). Longer sleep duration was associated with an increased presence of cerebral microbleeds (OR, 1.42 per 1-SD increase; P = .04), although it was not significantly related to other SVD markers.
= .04), although it was not significantly related to other SVD markers. In-bed time (r, 0.52) and sleep efficiency (r, 0.56) were positively correlated with sleep duration; sleep latency was negatively correlated with sleep duration (r, −0.24; P < .001 for all).
IN PRACTICE:
"2 markers of disturbed sleep, longer in-bed time and longer sleep duration, were cross-sectionally associated with greater SVD burden and worse cognitive performance in patients with TIA/mild stroke," the authors wrote.
SOURCE:
This study was led by Dillys Xiaodi Liu, Division of Neurology, Department of Medicine, The University of Hong Kong, Hong Kong, China, and was published online on May 28, 2025, in Neurology .
LIMITATIONS:
The cross-sectional design and visual assessments of WMHs and brain atrophy limited precision. Patients with a history of sleep apnoea were not excluded, and changes in sleep quality over time were not assessed. As only baseline cross-sectional data were analysed, causal relationships cannot be established, and findings may differ in longitudinal contexts.
DISCLOSURES:
This study was supported by the UK Dementia Research Institute, European Union Horizon 2020, Row Fogo Charitable Trust, and other funding agencies. The authors reported having no conflicts of interest.
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Business Wire
07-07-2025
- Business Wire
CorFlow Therapeutics宣布MOCA-II IDE關鍵性試驗獲得FDA核准,旨在驗證新型心臟病發作治療技術
瑞士巴爾--(BUSINESS WIRE)--(美國商業資訊)-- 專注於微血管疾病的心臟護理領域先驅企業 CorFlow Therapeutics AG (CorFlow) 今日宣布,該公司的技術已獲得美國食品藥物管理局(FDA)的研究性器材豁免(IDE)核准,這表示關鍵性臨床試驗可在美國各醫院啟動。CorFlow目前正準備為這些臨床試驗中心配備CorFlow系統,展開相關培訓,並開始招募接受心臟病治療的病患。 這項名為MOCA-II的IDE關鍵性試驗旨在前瞻性驗證專有CorFlow CoFl系統在原發性經皮冠狀動脈介入治療(PCI)過程中診斷微血管阻塞(MVO)存在與否的準確性。主要終點是將CoFI診斷結果與心臟磁振造影(MRI)掃描的診斷參考標準進行對比。該試驗已獲准在美國和歐洲的知名研究機構招募200多名ST段上升型心肌梗塞(STEMI)病患。 在2024年成功完成MOCA-I首次人體試驗後,MOCA-II研究成為將這一獨特技術推向全球介入心臟病學家的關鍵一步,協助其快速診斷心臟病發作病患的MVO問題。這進而可望為大量MVO病患帶來新的治療方法和護理路徑——目前這類病患的臨床不良結局發生率較高。CorFlow技術不僅旨在診斷MVO,還能做為局部藥物遞送系統,用於輸送診斷劑和治療劑,相關研究正在獨立進行中。 美國政府疾病控制與預防中心的資料顯示,美國每30秒就有一人突發心臟病,每年報告病例約80萬例。歐洲的發病率和患病率也處於類似高位。超過一半的STEMI心臟病發作病患被證實存在MVO,且既往研究顯示,MVO的存在是導致不良事件的主要因素。目前,在歐美地區,尚無獲准可在急性冠狀動脈介入治療期間診斷MVO的技術,也沒有專門針對MVO的獲准治療器材。心臟病發作及相關心臟疾病仍是全球導致死亡和身心障礙的主要原因之一。 CorFlow執行長Paul Mead表示:「介入心臟病學和心臟病發作護理領域的突破可追溯至100多年前,這是醫療護理進步的重大成功案例之一,但該領域的先驅和傑出人士都認同,這項工作尚未完成。大多數急性STEMI倖存者存在MVO問題,而目前這些病患的預後差得驚人。我們旨在揭露這一問題,並證明人們能夠為此採取行動。這一里程碑讓我們向兌現改善這些病患護理的承諾又邁進了一步——我們深知在這方面我們能做得更好。」 MOCA-II試驗由心臟病發作護理領域的世界知名專家主導,分別是美國俄亥俄州辛辛那提市基督醫院的Timothy Henry博士,以及瑞士盧加諾市提契諾心臟中心研究所的Marco Valgimigli教授。兩人在心血管研究領域共發表了超過1000篇經同儕審查的論文。 Tim Henry博士表示:「身為一名從事STEMI病患治療和研究數十年的介入心臟病學家,我對這項關鍵性試驗的啟動感到振奮不已——相關技術可望對病患的預後產生重大影響。我堅信,在原發性PCI過程中,在護理現場高度確信哪些病患存在MVO,能立即改變我們對病患的治療方式。」Valgimigli教授補充說道:「我是MOCA-I首次人體試驗的重要參與者,如今看到第二代技術可用於關鍵性試驗,我感到非常激動,並期待能進一步協助對MVO的即時科學理解。儘管醫學界對於如何治療這類病患存在不同觀點,但毫無疑問,準確診斷是我們需要邁出的第一步。我樂觀地認為,CorFlow技術獲准供同行介入心臟病學家日常使用後,將有助於推動該領域的發展。」 關於CorFlow Therapeutics:公司總部位於瑞士巴爾,在義大利和美國設有子公司。CorFlow由國際創投公司共同投資,最近一輪融資是2024年9月宣布的B輪融資。CorFlow立志成為診斷和治療解決方案領域的領導者,以恢復存在關鍵需求的人體任何部位的健康微血管血流。在瑞士創新署(Innosuisse)的資助下,CorFlow與伯恩大學、蘇黎世聯邦理工學院和蘇黎世大學醫院的科學家密切合作,持續探索這項獨特專利技術的應用場景。 免責聲明:本公告之原文版本乃官方授權版本。譯文僅供方便瞭解之用,煩請參照原文,原文版本乃唯一具法律效力之版本。

Business Upturn
07-07-2025
- Business Upturn
CorFlow Therapeutics Announces FDA Approval of the MOCA-II IDE Pivotal Trial to Validate a Novel Heart Attack Care Technology
Business Wire India CorFlow Therapeutics AG (CorFlow), a pioneering company in the field of cardiac care targeting microvascular disease, today announced that the U.S. Food & Drug Administration (FDA) has approved the company's technology for investigational device exemption (IDE), which allows the pivotal clinical trial to begin at U.S. hospitals. CorFlow will now prepare these clinical trial sites to receive CorFlow systems, undergo training and begin enrolling patients being treated for heart attacks. The IDE Pivotal Trial, MOCA-II, is intended to prospectively validate the diagnostic accuracy of the proprietary CorFlow CoFl system in determining the presence or absence of microvsacular obstruction (MVO) during a primary PCI procedure. The primary endpoint compares the CoFI diagnostic reading to a reference standard of diagnosis by a cardiac MRI scan. The trial is approved to enroll over 200 STEMI patients at prestigious research institutions in both the United States and Europe. Having successfully completed the first-in-human MOCA-I trial in 2024, the MOCA-II study is the next critical step to bringing this unique technology into the hands of interventional cardiologists globally for the rapid diagnosis of MVO in heart attack patients. This in turn can enable new treatments and care pathways to the large MVO patient population with high rates of adverse clinical outcomes today. The CorFlow technology is designed to both diagnose MVO, plus serve as a localized drug delivery system for diagnostic and therapeutic agents, which is being researched independently. According to the US government Centers for Disease Control and Prevention, someone has a heart attack every 30 seconds in the USA, with about 800,000 cases reported annually in the country. Incidence and prevalence are similarly high in Europe. More than half of STEMI heart attack patients are shown to have MVO, and previous research has demonstrated that the presence of MVO is a major driver of adverse events. Currently, there are no technologies approved to diagnose MVO during an acute coronary intervention, and there are no approved therapeutic devices that specifically address MVO in the United States or Europe. Heart attacks and related heart disease remains a leading cause of death and disability worldwide. Paul Mead, CEO of CorFlow, said, 'The long history of interventional cardiology and heart attack care breakthroughs – going back over 100 years – is one of the great success stories of medical care progress, but the pioneers and luminaries of the field all agree that the work is unfinished. The majority of acute STEMI survivors have MVO, and current outcomes for these patients are shockingly poor. We aim to bring this issue to light and show you can do something about it. This milestone brings us all one step closer to delivering on the promise to improving care for these people where we know we can do better.' MOCA-II is being led by world-renowned experts in heart attack care, Dr. Timothy Henry at The Christ Hospital in Cincinnati, Ohio (United States) and Professor Marco Valgimigli at Cardiocentro Ticino Institute, Lugano (Switzerland), who collectively have been published in over 1,000 peer-reviewed manuscripts in cardiovascular research. Dr. Tim Henry said, 'As an interventional cardiologist involved for decades in managing and researching STEMI patients, I am excited to get going on this pivotal trial with technology that could make such a significant impact to the outcome of our patients. I believe strongly that knowing with high confidence who has MVO at the point of care during a primary PCI procedure can make an immediate difference in how we manage our patients.' Professor Valgimigli added, 'Having played a significant part in MOCA-I first in human trial, I am thrilled to see the second-generation technology now available for the pivotal trial and am looking forward to contributing further to the scientific understanding of MVO in real time. While the medical community has diverse opinions on how to treat these patients, there is no question that proper diagnosis is the first step we need. I am optimistic that getting the CorFlow technology approved for everyday use by our peer interventional cardiologists can help move the field forward.' About CorFlow Therapeutics: Headquartered in Baar, Switzerland, with subsidiary operations in both Italy and the United States. The company is venture capital funded with an international VC firm syndicate, most recently with a Series B financing round announced in September 2024. CorFlow aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. Working in close partnership with scientists from the University of Bern, ETH Zurich and the University Hospital Zurich, in a collaboration funded by the Swiss Innovation Agency (Innosuisse), CorFlow continues to explore applications for the unique patented technology. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire India. Business Upturn take no editorial responsibility for the same. Ahmedabad Plane Crash


Business Wire
07-07-2025
- Business Wire
CorFlow Therapeutics Announces FDA Approval of the MOCA-II IDE Pivotal Trial to Validate a Novel Heart Attack Care Technology
BAAR, Switzerland--(BUSINESS WIRE)-- CorFlow Therapeutics AG (CorFlow), a pioneering company in the field of cardiac care targeting microvascular disease, today announced that the U.S. Food & Drug Administration (FDA) has approved the company's technology for investigational device exemption (IDE), which allows the pivotal clinical trial to begin at U.S. hospitals. CorFlow will now prepare these clinical trial sites to receive CorFlow systems, undergo training and begin enrolling patients being treated for heart attacks. CorFlow Therapeutics Announces FDA Approval of the MOCA-II IDE Pivotal Trial to Validate a Novel Heart Attack Care Technology Share The IDE Pivotal Trial, MOCA-II, is intended to prospectively validate the diagnostic accuracy of the proprietary CorFlow CoFl system in determining the presence or absence of microvsacular obstruction (MVO) during a primary PCI procedure. The primary endpoint compares the CoFI diagnostic reading to a reference standard of diagnosis by a cardiac MRI scan. The trial is approved to enroll over 200 STEMI patients at prestigious research institutions in both the United States and Europe. Having successfully completed the first-in-human MOCA-I trial in 2024, the MOCA-II study is the next critical step to bringing this unique technology into the hands of interventional cardiologists globally for the rapid diagnosis of MVO in heart attack patients. This in turn can enable new treatments and care pathways to the large MVO patient population with high rates of adverse clinical outcomes today. The CorFlow technology is designed to both diagnose MVO, plus serve as a localized drug delivery system for diagnostic and therapeutic agents, which is being researched independently. According to the US government Centers for Disease Control and Prevention, someone has a heart attack every 30 seconds in the USA, with about 800,000 cases reported annually in the country. Incidence and prevalence are similarly high in Europe. More than half of STEMI heart attack patients are shown to have MVO, and previous research has demonstrated that the presence of MVO is a major driver of adverse events. Currently, there are no technologies approved to diagnose MVO during an acute coronary intervention, and there are no approved therapeutic devices that specifically address MVO in the United States or Europe. Heart attacks and related heart disease remains a leading cause of death and disability worldwide. Paul Mead, CEO of CorFlow, said, 'The long history of interventional cardiology and heart attack care breakthroughs – going back over 100 years – is one of the great success stories of medical care progress, but the pioneers and luminaries of the field all agree that the work is unfinished. The majority of acute STEMI survivors have MVO, and current outcomes for these patients are shockingly poor. We aim to bring this issue to light and show you can do something about it. This milestone brings us all one step closer to delivering on the promise to improving care for these people where we know we can do better.' MOCA-II is being led by world-renowned experts in heart attack care, Dr. Timothy Henry at The Christ Hospital in Cincinnati, Ohio (United States) and Professor Marco Valgimigli at Cardiocentro Ticino Institute, Lugano (Switzerland), who collectively have been published in over 1,000 peer-reviewed manuscripts in cardiovascular research. Dr. Tim Henry said, 'As an interventional cardiologist involved for decades in managing and researching STEMI patients, I am excited to get going on this pivotal trial with technology that could make such a significant impact to the outcome of our patients. I believe strongly that knowing with high confidence who has MVO at the point of care during a primary PCI procedure can make an immediate difference in how we manage our patients.' Professor Valgimigli added, 'Having played a significant part in MOCA-I first in human trial, I am thrilled to see the second-generation technology now available for the pivotal trial and am looking forward to contributing further to the scientific understanding of MVO in real time. While the medical community has diverse opinions on how to treat these patients, there is no question that proper diagnosis is the first step we need. I am optimistic that getting the CorFlow technology approved for everyday use by our peer interventional cardiologists can help move the field forward.' About CorFlow Therapeutics: Headquartered in Baar, Switzerland, with subsidiary operations in both Italy and the United States. The company is venture capital funded with an international VC firm syndicate, most recently with a Series B financing round announced in September 2024. CorFlow aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists. Working in close partnership with scientists from the University of Bern, ETH Zurich and the University Hospital Zurich, in a collaboration funded by the Swiss Innovation Agency (Innosuisse), CorFlow continues to explore applications for the unique patented technology.