Understanding heart issues after brain injuries
Lesion-Network Mapping Analysis With Brain Connectomics to Reveal the Neural Mechanisms of Cerebrocardiac Syndrome Following Traumatic Brain Injury
This study is trying to understand how brain injuries can cause heart problems and see if there are ways to help patients with these issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai 6th People's Hospital Academic / other |
| Locations | 2 sites (Shanghai and 1 other locations) |
| Trial ID | NCT06958406 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the neural mechanisms behind cerebrocardiac syndrome (CCS) that can occur following traumatic brain injury (TBI). It aims to explore how TBI affects the autonomic nervous system and contributes to heart complications such as myocardial injury and arrhythmias. By utilizing emerging research in brain connectomics, the study seeks to identify specific brain patterns that may lead to CCS and evaluate potential noninvasive interventions to maintain autonomic balance. The goal is to improve prevention and treatment strategies for patients experiencing CCS after TBI.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 who have experienced isolated closed head trauma and have a mild to moderate TBI.
Not a fit: Patients with severe TBI or pre-existing heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prevention and treatment options for heart complications following traumatic brain injuries.
How similar studies have performed: While the specific approach of this study is novel, there is accumulating evidence suggesting that understanding the autonomic nervous system's role in TBI could lead to significant advancements in treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Shanghai and 1 other locations
- Shanghai 6th People's Hospital — Shanghai, China (Recruiting)
- Shanghai Sixth People's Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Lai Wei, M.D. — Shanghai 6th Peoples' Hospital
- Study coordinator: Hao Chen, M.D., Ph.D.
- Email: hao.chen@shsmu.edu.cn
- Phone: 8602164369181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.