Sarah Marchina, Lydia D Foster, Sharon D Yeatts, Pooja Khatri, Kimberlee Bernstein, Aaron Perlmutter, Elizabeth C Heistand, Eric E Smith, Mike Sharma, Joseph P Broderick, Vasileios-Arsenios Lioutas, Joan Marti-Fabregas, Magdy Selim, Ashkan Shoamanesh
{"title":"SATURN MRI：他汀类药物用于脑出血患者MRI辅助研究的研究方案。","authors":"Sarah Marchina, Lydia D Foster, Sharon D Yeatts, Pooja Khatri, Kimberlee Bernstein, Aaron Perlmutter, Elizabeth C Heistand, Eric E Smith, Mike Sharma, Joseph P Broderick, Vasileios-Arsenios Lioutas, Joan Marti-Fabregas, Magdy Selim, Ashkan Shoamanesh","doi":"10.1186/s13063-025-09024-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The benefit-risk of statins in patients with lobar intracerebral hemorrhage (ICH) is under investigation in the StATins Use in intRacerebral hemorrhage patieNts (SATURN) trial. The relationship between statin use in ICH survivors, MRI markers of cerebral small vessel disease (CSVD), and outcomes such as recurrent ICH or major adverse cardiovascular or cerebrovascular events (MACCE) is unclear. The ancillary study, SATURN-MRI, intends to evaluate the interrelationship between statin use, the progression of MRI markers of CSVD, and cognitive and functional outcomes. Additionally, SATURN-MRI aims to assess whether baseline MRI markers of CSVD interact with statin continuation for the outcomes of recurrent ICH or MACCE in patients with lobar ICH.</p><p><strong>Methods: </strong>A target of 894 SATURN participants will undergo a baseline MRI within 7 days of randomization and a repeat MRI at the end of the 24-month follow-up period. Any SATURN subject without contraindication to MRI has the option to participate in SATURN MRI. MRIs will be reviewed by blinded central raters to assess for the presence and burden of markers of CSVD and their progression. The primary outcome is new cerebral microbleeds and/or sulci with cortical superficial siderosis identified on T2*-weighted (GRE, SWI or SWAN) images between baseline and end-study MRI. Additional outcomes include the progression of white matter hyperintensity and incidence of covert infarcts.</p><p><strong>Discussion: </strong>The results will provide insights about the interrelationship between the effects of statins, progression of MRI markers of CSVD, and functional and cognitive outcomes. They might lead to the validation of MRI markers as tools to assist with individualized decision-making regarding the effects of statins continuation/discontinuation in patients with lobar ICH.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03936361. SATURN Trial was originally registered on May 1, 2019 and modified on February 28, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"323"},"PeriodicalIF":2.0000,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398981/pdf/","citationCount":"0","resultStr":"{\"title\":\"SATURN MRI: study protocol for the statin use in intracerebral hemorrhage patients MRI ancillary study.\",\"authors\":\"Sarah Marchina, Lydia D Foster, Sharon D Yeatts, Pooja Khatri, Kimberlee Bernstein, Aaron Perlmutter, Elizabeth C Heistand, Eric E Smith, Mike Sharma, Joseph P Broderick, Vasileios-Arsenios Lioutas, Joan Marti-Fabregas, Magdy Selim, Ashkan Shoamanesh\",\"doi\":\"10.1186/s13063-025-09024-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The benefit-risk of statins in patients with lobar intracerebral hemorrhage (ICH) is under investigation in the StATins Use in intRacerebral hemorrhage patieNts (SATURN) trial. The relationship between statin use in ICH survivors, MRI markers of cerebral small vessel disease (CSVD), and outcomes such as recurrent ICH or major adverse cardiovascular or cerebrovascular events (MACCE) is unclear. The ancillary study, SATURN-MRI, intends to evaluate the interrelationship between statin use, the progression of MRI markers of CSVD, and cognitive and functional outcomes. Additionally, SATURN-MRI aims to assess whether baseline MRI markers of CSVD interact with statin continuation for the outcomes of recurrent ICH or MACCE in patients with lobar ICH.</p><p><strong>Methods: </strong>A target of 894 SATURN participants will undergo a baseline MRI within 7 days of randomization and a repeat MRI at the end of the 24-month follow-up period. Any SATURN subject without contraindication to MRI has the option to participate in SATURN MRI. MRIs will be reviewed by blinded central raters to assess for the presence and burden of markers of CSVD and their progression. The primary outcome is new cerebral microbleeds and/or sulci with cortical superficial siderosis identified on T2*-weighted (GRE, SWI or SWAN) images between baseline and end-study MRI. Additional outcomes include the progression of white matter hyperintensity and incidence of covert infarcts.</p><p><strong>Discussion: </strong>The results will provide insights about the interrelationship between the effects of statins, progression of MRI markers of CSVD, and functional and cognitive outcomes. They might lead to the validation of MRI markers as tools to assist with individualized decision-making regarding the effects of statins continuation/discontinuation in patients with lobar ICH.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03936361. SATURN Trial was originally registered on May 1, 2019 and modified on February 28, 2022.</p>\",\"PeriodicalId\":23333,\"journal\":{\"name\":\"Trials\",\"volume\":\"26 1\",\"pages\":\"323\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-08-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398981/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s13063-025-09024-0\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-025-09024-0","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
SATURN MRI: study protocol for the statin use in intracerebral hemorrhage patients MRI ancillary study.
Background: The benefit-risk of statins in patients with lobar intracerebral hemorrhage (ICH) is under investigation in the StATins Use in intRacerebral hemorrhage patieNts (SATURN) trial. The relationship between statin use in ICH survivors, MRI markers of cerebral small vessel disease (CSVD), and outcomes such as recurrent ICH or major adverse cardiovascular or cerebrovascular events (MACCE) is unclear. The ancillary study, SATURN-MRI, intends to evaluate the interrelationship between statin use, the progression of MRI markers of CSVD, and cognitive and functional outcomes. Additionally, SATURN-MRI aims to assess whether baseline MRI markers of CSVD interact with statin continuation for the outcomes of recurrent ICH or MACCE in patients with lobar ICH.
Methods: A target of 894 SATURN participants will undergo a baseline MRI within 7 days of randomization and a repeat MRI at the end of the 24-month follow-up period. Any SATURN subject without contraindication to MRI has the option to participate in SATURN MRI. MRIs will be reviewed by blinded central raters to assess for the presence and burden of markers of CSVD and their progression. The primary outcome is new cerebral microbleeds and/or sulci with cortical superficial siderosis identified on T2*-weighted (GRE, SWI or SWAN) images between baseline and end-study MRI. Additional outcomes include the progression of white matter hyperintensity and incidence of covert infarcts.
Discussion: The results will provide insights about the interrelationship between the effects of statins, progression of MRI markers of CSVD, and functional and cognitive outcomes. They might lead to the validation of MRI markers as tools to assist with individualized decision-making regarding the effects of statins continuation/discontinuation in patients with lobar ICH.
Trial registration: ClinicalTrials.gov NCT03936361. SATURN Trial was originally registered on May 1, 2019 and modified on February 28, 2022.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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