Neural Mechanism of Cerebrocardiac Syndrome Following Traumatic Brain Injury

NCT06958406 | Recruiting

• 1 other identifier: 2024-KY-136（K）
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Traumatic Brain Injury; Cerebrocardiac Syndrome

Keywords

traumatic brain injury; cerebrocardiac syndrome; brain connectomics

Outcome Measures

Primary Outcomes (5)

• Brain network evaluation by MRI

  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.

  Within 3 days after enrollment

• Cardiac evaluation by ECG

  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.

  Within 3 days after enrollment

• Cardiac evaluation by echocardiography

  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.

  Within 3 days after enrollment

• Cardiac evaluation by blood testing-1

  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.

  Within 3 days after enrollment

• Cardiac evaluation by blood testing-2

  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.

  Within 3 days after enrollment

Secondary Outcomes (2)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Traumatic brain injury patients and healthy volunteers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (2)

Shanghai 6th People's Hospital

Shanghai, 200233, China

RECRUITING

Shanghai Sixth People's Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Neurocirculatory Asthenia

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Anxiety Disorders; Mental Disorders

Study Officials

• Hao Chen, M.D., Ph.D.

  Shanghai 6th Peoples' Hospital

  STUDY DIRECTOR

• Lai Wei, M.D.

  Shanghai 6th Peoples' Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Chen, M.D., Ph.D.

CONTACT

8602164369181; hao.chen@shsmu.edu.cn

Lai Wei, M.D.

CONTACT

8602164369181; WL990126@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Chief Physician, Graduate Supervisor

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: May 6, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (2)