Chinese Multicenter Prospective Cohort Study of Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Distribution of modified Rankin Scale scores at 90 day
研究概览
简要总结
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.
详细描述
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/or 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.
At 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.
Participants 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.
The primary outcome is the ordinal distribution of modified Rankin Scale scores from 0 (no symptoms) to 6 (death) at 90 days. The key secondary/supportive 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.
The 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intracerebral Hemorrhage Cohort:
- •Age 18 years or older.
- •Intracerebral hemorrhage confirmed by head computed tomography and/or magnetic resonance imaging.
- •Hemorrhage located in a deep cerebral region, cerebral lobe, cerebellum, or brainstem.
- •Presentation to a participating hospital within 30 days after symptom onset.
- •Written informed consent and broad consent provided in accordance with the ethics-approved process.
排除标准
- •Intracerebral Hemorrhage Cohort:
- •Traumatic intracerebral hemorrhage.
- •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.
- •Mixed intracerebral hemorrhage involving multiple deep and lobar locations at onset.
- •Severe psychiatric disease that precludes study procedures or follow-up.
- •End-stage hepatic or renal failure.
- •Autoimmune disease judged by the investigator to materially affect study objectives.
- •Active malignant tumor.
- •Pregnancy.
- •Any other condition that the investigator judges makes participation inappropriate.
- •Inclusion Criteria - Healthy Control Cohort:
- •Age 18 years or older.
- •Able to provide written informed consent.
- •No known history of intracerebral hemorrhage.
- •Exclusion Criteria - Healthy Control Cohort:
- •Malignant tumor.
- •Neurologic disease, particularly any prior intracerebral hemorrhage.
- •Any other condition that the investigator judges makes participation inappropriate.
研究组 & 干预措施
Spontaneous intracerebral hemorrhage cohort
Approximately 10,000 adults with spontaneous intracerebral hemorrhage confirmed by computed tomography and/or 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.
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.
结局指标
主要结局
Distribution of modified Rankin Scale scores at 90 day
时间窗: 90 days after intracerebral hemorrhage onset
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.
次要结局
- Unfavorable functional outcome at 90 days(90 days after intracerebral hemorrhage onset)
- Distribution of modified Rankin Scale scores during longer-term follow-up(6 months and annually from year 1 through year 10 after intracerebral hemorrhage onset)
- All-cause mortality(From enrollment through 10 years after intracerebral hemorrhage onset)
- Recurrent symptomatic intracerebral hemorrhage(From enrollment through 10 years after the index intracerebral hemorr)
- Early hematoma expansion(Baseline imaging to the first clinically obtained follow-up computed tomography within 72 hours)
- Change in perihematomal edema volume(Baseline imaging to follow-up neuroimaging within 72 hours)
- Area Under the Receiver Operating Characteristic Curve of the Multimodal Model(90 days after intracerebral hemorrhage onset)
- Calibration Intercept of the Multimodal Model(90 days after intracerebral hemorrhage onset)
- Calibration Slope of the Multimodal Model(90 days after intracerebral hemorrhage onset)
- Brier Score of the Multimodal Model(90 days after intracerebral hemorrhage onset)
- Decision-Curve Net Benefit of the Multimodal Model(90 days after intracerebral hemorrhage onset)