[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656951":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":56,"studyPopulation":57,"armGroups":58,"interventions":52,"overallOfficials":52,"centralContacts":65,"locations":71,"responsibleParty":87,"collaborators":52,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":52,"enrollmentInfo":100,"targetDuration":103,"studyType":104,"phases":52,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":74,"whyStopped":52,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Xiangya Hospital of Central South University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Distribution of modified Rankin Scale scores at 90 day","Ordinal distribution of modified Rankin Scale scores among participants with intracerebral hemorrhage. The scale ranges from 0 (no symptoms) to 6 (death); higher scores indicate worse functional outcome. The primary analysis uses all seven ordered categories rather than dichotomizing the scale.","90 days after intracerebral hemorrhage onset",[14,17,21,25,29,33,37,40,43,46,49],{"measure":15,"description":16,"timeFrame":12},"Unfavorable functional outcome at 90 days","Proportion of participants with an mRS score of 4-6. This key secondary\u002Fsupportive binary endpoint is used for prognostic-model development and corresponds to the adverse functional outcome used in the protocol's sample-size calculation.",{"measure":18,"description":19,"timeFrame":20},"Distribution of modified Rankin Scale scores during longer-term follow-up","Ordinal distribution of mRS scores from 0 (no symptoms) to 6 (death) at each prespecified follow-up.","6 months and annually from year 1 through year 10 after intracerebral hemorrhage onset",{"measure":22,"description":23,"timeFrame":24},"All-cause mortality","Death from any cause ascertained by follow-up contact, medical records, and available death-registration or health insurance linkage.","From enrollment through 10 years after intracerebral hemorrhage onset",{"measure":26,"description":27,"timeFrame":28},"Recurrent symptomatic intracerebral hemorrhage","A new acute neurologic event with new intracerebral hemorrhage confirmed by computed tomography or magnetic resonance imaging and adjudicated according to the study endpoint definition.","From enrollment through 10 years after the index intracerebral hemorr",{"measure":30,"description":31,"timeFrame":32},"Early hematoma expansion","Increase in intraparenchymal hematoma volume of more than 6 mL or more than 33% from baseline. Participants without an eligible follow-up scan will be reported separately and will not be assumed to have no expansion.","Baseline imaging to the first clinically obtained follow-up computed tomography within 72 hours",{"measure":34,"description":35,"timeFrame":36},"Change in perihematomal edema volume","Absolute and relative change in segmented perihematomal edema volume between baseline and follow-up imaging.","Baseline imaging to follow-up neuroimaging within 72 hours",{"measure":38,"description":39,"timeFrame":12},"Area Under the Receiver Operating Characteristic Curve of the Multimodal Model","Discrimination of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, reported as the area under the receiver operating characteristic curve (AUROC) with a 95% confidence interval.",{"measure":41,"description":42,"timeFrame":12},"Calibration Intercept of the Multimodal Model","Calibration-in-the-large of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, reported as a unitless calibration intercept. An intercept of 0 indicates ideal calibration.",{"measure":44,"description":45,"timeFrame":12},"Calibration Slope of the Multimodal Model","Calibration of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, reported as a unitless calibration slope. A slope of 1 indicates ideal calibration.",{"measure":47,"description":48,"timeFrame":12},"Brier Score of the Multimodal Model","Overall prediction error of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, reported as a unitless Brier score ranging from 0 to 1. Lower values indicate better overall predictive accuracy.",{"measure":50,"description":51,"timeFrame":12},"Decision-Curve Net Benefit of the Multimodal Model","Clinical utility of the prespecified multimodal prediction model for unfavorable functional outcome (modified Rankin Scale score 4-6) at 90 days, assessed by decision-curve analysis and reported as unitless net benefit across prespecified probability thresholds. Net benefit will be compared with treat-all and treat-none strategies.",null,{"allocation":52,"interventionModel":52,"interventionModelDescription":52,"primaryPurpose":52,"observationalModel":54,"timePerspective":55,"maskingInfo":52},"COHORT","PROSPECTIVE","CASA is a multicenter, prospective, observational cohort and patient registry coordinated by Xiangya Hospital, Central South University. Consecutive adults with spontaneous intracerebral hemorrhage confirmed by computed tomography and\u002For magnetic resonance imaging are identified within 30 days after symptom onset. A healthy comparison cohort is recruited from participating health examination programs and communities. The planned sample comprises 10,000 participants with intracerebral hemorrhage and 2,000 healthy controls.\n\nAt baseline, trained investigators obtain demographic characteristics, medical and family history, prior medications, vascular risk factors, smoking, alcohol use, dietary and sleep habits, vital signs, neurological severity scores, functional status, laboratory tests, electrocardiography, vascular examinations, treatments, complications, and discharge information. Original computed tomography, computed tomography angiography, magnetic resonance imaging, magnetic resonance angiography, diffusion-weighted imaging, susceptibility-weighted imaging, and digital subtraction angiography are collected when performed as part of clinical care. Imaging is stored in Digital Imaging and Communications in Medicine format. Biospecimens are processed under standardized operating procedures, assigned coded identifiers, and stored centrally for genomic, transcriptomic, proteomic, metabolomic, lipidomic, epigenomic, and other prespecified analyses, within the scope of the ethics-approved consent.\n\nParticipants with intracerebral hemorrhage are followed at 3 months, 6 months, and annually from year 1 through year 10. Follow-up records functional outcome using the modified Rankin Scale, recurrent symptomatic intracerebral hemorrhage, and vital status. Outcomes are obtained through clinic review, telephone follow-up, family contact, and linkage to available health insurance and death-registration data. Participants not reached after at least three attempts on different dates in different months within a 12-month period are classified as lost to follow-up after additional tracing efforts.\n\nThe primary outcome is the ordinal distribution of modified Rankin Scale scores from 0 (no symptoms) to 6 (death) at 90 days. The key secondary\u002Fsupportive outcome is 90-day unfavorable functional outcome, defined as mRS 4-6; this binary endpoint is also used in the protocol's minimum sample-size calculation for prognostic modelling. Other secondary analyses evaluate later mRS distributions, all-cause mortality, recurrent symptomatic intracerebral hemorrhage, hematoma expansion, perihematomal edema, and biomarker-outcome associations. Prediction models will be developed using clinical, imaging, and molecular data. Sites in Hunan, Jiangxi, and Hubei provinces are planned as the development cohort, and sites in other provinces as a geographically external evaluation cohort. Model performance will include discrimination, calibration, overall accuracy, and clinical utility.\n\nThe registry uses a centralized electronic data capture system, prespecified data definitions, logic and range checks, staff training, source-data review, periodic monitoring, and repeat assessment in a random 3% sample at participating sites. Biospecimen collection, transport, processing, and storage follow harmonized operating procedures with temperature monitoring and chain-of-custody records.\n\nThe study began before public registration. This retrospective registration is based on protocol version 1.0 dated 9 December 2023, initially approved on 25 January 2024 (No. 202401026). The original protocol prespecified mRS follow-up and used mRS 4-6 in its prognostic-model sample-size calculation but did not label one outcome as primary. Before PRS submission, the steering committee formalized the 90-day ordinal mRS distribution as the primary outcome and mRS 4-6 at 90 days as the key secondary\u002Fsupportive outcome. The decision, its date and the absence of outcome-informed changes should be recorded in a signed protocol clarification or statistical analysis plan.","Adults with imaging-confirmed spontaneous intracerebral hemorrhage presenting within 30 days after symptom onset to more than 30 participating hospitals in China are recruited consecutively. Adult healthy controls without neurologic disease are recruited from participating health examination programs and communities. The coordinating center is Xiangya Hospital, Central South University, Changsha, China.",[59,62],{"label":60,"type":52,"description":61,"interventionNames":52},"Spontaneous intracerebral hemorrhage cohort","Approximately 10,000 adults with spontaneous intracerebral hemorrhage confirmed by computed tomography and\u002For magnetic resonance imaging, enrolled within 30 days after symptom onset at participating hospitals. Participants receive usual care determined by treating clinicians and undergo standardized baseline assessment, collection of approved biospecimens, and longitudinal follow-up.",{"label":63,"type":52,"description":64,"interventionNames":52},"Healthy control cohort","Approximately 2,000 adults without a history of intracerebral hemorrhage or other neurologic disease, recruited from participating health examination programs or communities. Controls undergo standardized baseline assessment and collection of approved biospecimens; no study-assigned treatment is provided.",[66],{"name":67,"role":68,"phone":69,"phoneExt":52,"email":70},"Le Zhang, Professor, MD","CONTACT","+86 178 7316 7010","zlzdzlzd@csu.edu.cn",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":52,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Xiangya Hospital, Central South University","RECRUITING","Changsha","Hunan","China","CN",{"type":80,"coordinates":81},"Point",[82,83],112.97087,28.19874,{"lat":83,"lon":82},[86],{"name":67,"role":68,"phone":69,"phoneExt":52,"email":70},{"type":88,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100656951","chinese-multicenter-cohort-study-of-intracerebral-hemorrhage-100656951",false,"NCT07833410","Chinese Multicenter Cohort Study of Intracerebral Hemorrhage","Chinese Multicenter Prospective Cohort Study of Intracerebral Hemorrhage","CMCS-ICH","Inclusion Criteria - Intracerebral Hemorrhage Cohort:\n\n* Age 18 years or older.\n* Intracerebral hemorrhage confirmed by head computed tomography and\u002For magnetic resonance imaging.\n* Hemorrhage located in a deep cerebral region, cerebral lobe, cerebellum, or brainstem.\n* Presentation to a participating hospital within 30 days after symptom onset.\n* Written informed consent and broad consent provided in accordance with the ethics-approved process.\n\nExclusion Criteria - Intracerebral Hemorrhage Cohort:\n\n* Traumatic intracerebral hemorrhage.\n* Secondary intracerebral hemorrhage attributed to an arteriovenous malformation, ruptured aneurysm, moyamoya disease, cavernous malformation, hematologic disorder, hemorrhagic tumor, vasculitis, cerebral venous thrombosis, hemorrhagic transformation of cerebral infarction, or other prespecified secondary cause.\n* Mixed intracerebral hemorrhage involving multiple deep and lobar locations at onset.\n* Severe psychiatric disease that precludes study procedures or follow-up.\n* End-stage hepatic or renal failure.\n* Autoimmune disease judged by the investigator to materially affect study objectives.\n* Active malignant tumor.\n* Pregnancy.\n* Any other condition that the investigator judges makes participation inappropriate.\n\nInclusion Criteria - Healthy Control Cohort:\n\n* Age 18 years or older.\n* Able to provide written informed consent.\n* No known history of intracerebral hemorrhage.\n\nExclusion Criteria - Healthy Control Cohort:\n\n* Malignant tumor.\n* Neurologic disease, particularly any prior intracerebral hemorrhage.\n* Any other condition that the investigator judges makes participation inappropriate.",true,"ALL","18 Years",{"count":101,"type":102},12000,"ESTIMATED","10 Years","OBSERVATIONAL","Spontaneous intracerebral hemorrhage is a severe form of stroke associated with high mortality and long-term disability. The Chinese Multicenter Cohort Study of Intracerebral Hemorrhage (CASA) is a prospective observational patient registry designed to enroll approximately 10,000 adults with imaging-confirmed spontaneous intracerebral hemorrhage and 2,000 adult healthy controls at more than 30 hospitals in China. The study will collect standardized clinical, laboratory, neuroimaging, lifestyle, and treatment data together with ethically approved blood, urine, and other biospecimens. Participants with intracerebral hemorrhage will be followed at 3 months, 6 months, and annually for up to 10 years. The primary objective is to characterize and identify determinants of the full distribution of modified Rankin Scale scores at 90 days. Secondary objectives include evaluating 90-day unfavorable functional outcome defined as mRS 4-6, recurrent intracerebral hemorrhage and mortality, identifying clinical and molecular biomarkers, and developing and externally evaluating multimodal prognostic models. The study does not assign treatment; all clinical care is determined by treating clinicians.",[107],"Intracerebral Hemorrhage",[109,110,111,112,113,114,115,116,117,118],"Spontaneous intracerebral hemorrhage","Hemorrhagic stroke","Prospective cohort","Hematoma expansion","Perihematomal edema","Functional outcome","Biomarker","Genomics","Multi-omics","Neuroimaging","2026-09-19",{"date":121,"type":122},"2026-09-22","ACTUAL",{"date":124,"type":122},"2024-02-01",{"date":126,"type":102},"2039-03-31",{"name":5,"class":6},1]