Lesion-Network Mapping Analysis With Brain Connectomics to Reveal the Neural Mechanisms of Cerebrocardiac Syndrome Following Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Brain network evaluation by MRI
研究概览
简要总结
Cerebrocardiac syndrome (CCS), including myocardial injury, arrhythmia or heart failure is one of serious complications of traumatic brain injury (TBI), mostly occurs within seven days after TBI, which directly aggravates the brain damage and affects the prognosis of TBI patients. Accumulative evidences suggest that autonomic nervous system disorder is a key initiation point for CCS, but how TBI affects the specific action patterns is not yet clear. Therefore, elucidating the neural mechanisms of TBI-induced CCS, maintaining the central sympathetic-parasympathetic balance through novel interventions such as noninvasive brain stimulation, may fundamentally block the downstream peripheral mechanism, thus achieving effective prevention and treatment for CCS. Based on the current emerging research in brain connectomics and lesion-symptom mapping, we speculate that cerebral contusions can cause structural or functional disconnection of key nodes in the central autonomic nervous system regulatory network, thereby mediating the occurrence of TBI-induced CCS.
In this study, magnetic resonance imaging (MRI) or functional MRI (fMRI) examinations were performed in patients with mild or moderate TBI with aim to explore the association between structural and functional disconnection caused by cerebral contusion and TBI-induced CCS, and to screen out the neural anatomical structures to predict CCS following TBI, providing therapy targets for prevention and treatment of CCS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with isolated closed head trauma
- •Age 18-80 years old
- •Admitted to hospital within 24 hours of injury
- •Mild or moderate TBI (Glasgow Coma Scale score of 9-15)
- •Signed consent form
排除标准
- •Severe TBI (Glasgow Coma Scale score of 3-8)
- •A history of stroke, TBI, intracranial tumor or surgery in the past 1 year
- •A history of coronary heart disease, structural heart disease and other primary heart diseases or suspected cardiac symptoms prior to injury
- •Causes of abnormal cardiac biomarkers such as renal insufficiency, severe anemia, sepsis, cardiotoxic drugs and so on
- •Not suitable for MRI examinations, such as pregnant women and those with metal implants in the body
- •Undergo surgery prior to MRI examinations or cardiac testing
研究组 & 干预措施
TBI-CCS
Patients with TBI-induced CCS, including myocardial injury, arrhythmia or heart failure.
Non TBI-CCS
Patients with non TBI-induced CCS.
Normal control
Normal healthy people.
结局指标
主要结局
Brain network evaluation by MRI
时间窗: Within 3 days after enrollment
MRI data of all participants are acquired within 3 days after enrollment, and the MRI scans include one or more of the following contents： 1. 3D T1-weighted images, which were acquired with a magnetization prepared rapid-acquisition gradient-echo sequence. 2. The resting state-fMRI data, acquired with an interleaved T2-weighted axial gradient-echo echoplanar imaging sequence. 3. DTI datasets, acquired using a fully-sampled spin-echo EPI sequence.
Cardiac evaluation by ECG
时间窗: Within 3 days after enrollment
ECG data of all participants are acquired within 3 days after enrollment, and include resting and ambulatory ECG to detect arrhythmias, heart rate variability or myocardial ischemia. Specifically, arrhythmias include atrial fibrillation (irregular R-R intervals, absent P waves, fibrillatory waves), ventricular tachycardia (QRS \>120 ms, rapid rate, often no discernible P waves), heart blocks (1st degree: PR interval \>200 ms; 2nd degree: progressive PR prolongation until a QRS drops; 3rd degree: complete AV dissociation and atrial rate \> ventricular rate) and premature contractions (early beats with wide or narrow QRS). Heart rate variability is analyzed via R-R interval variability over time (24-hour Holter), and the indicators include Time-Domain (SDNN and RMSSD) and Frequency-Domain (LF/HF ratio). Myocardial ischemia indicators include ST segment depression ≥0.5 mm in ≥2 contiguous leads, ST elevation ≥1 mm in ≥2 contiguous leads, and inversion or hyperacute T waves.
Cardiac evaluation by echocardiography
时间窗: Within 3 days after enrollment
Echocardiography data of all participants are acquired within 3 days after enrollment, in order to assess heart pumping function. Specifically, the key parameters assessed include ventricular function (ejection fraction: % of blood ejected per beat) and cardiac output quantification. The decline in the above indicators suggests heart ischemia or heart failure.
Cardiac evaluation by blood testing-1
时间窗: Within 3 days after enrollment
Blood testing data of all participants are acquired within 3 days after enrollment and include several key cardiac biomarkers: myoglobin (normal: 14.3-65.8 μg/L), cardiac troponin I (cTnI, normal: 0-0.03 μg/L), cardiac troponin T (cTnT, normal: 0-0.1 μg/L), B-type natriuretic peptide (BNP, normal: 0-0.1 μg/L) and NT-proBNP (normal: \<0.3 μg/L). Specifically, elevated myoglobin is useful for early detection of myocardial infarction (MI); elevated cTnI and cTnT, especially with a rising/falling pattern, are gold standard for diagnosing MI; elevated BNP and NT-proBNP suggest heart failure (HF), especially BNP \>0.4 μg/L indicates severe HF.
Cardiac evaluation by blood testing-2
时间窗: Within 3 days after enrollment
Blood testing data of all participants are acquired within 3 days after enrollment and include the following cardiac biomarkers: creatine kinase (CK, normal: 21-190 U/L ), CK-MB (normal: 0-25 U/L) and lactate dehydrogenase (LDH, normal: 114-240 U/L). Specifically, elevated CK and CK-MB suggest cardiac muscle injury; elevated LDH are useful for early detection of MI.
次要结局
- Clinical prognosis assessed by GOS score(One month, three and six months after trauma)
- Neurological function assessed by mRS score(One month, three and six months after trauma)
研究者
Hao Chen, MD, PhD
Associate Professor, Chief Physician, Graduate Supervisor
Shanghai 6th People's Hospital