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Recruiting NCT06906432

Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage

— Observational Subarachnoid Hemorrhage, Aneurysmal Cerebrocardiac Syndrome Mass Spectrometry Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multi-disciplinary assessment.
Who it may be relevant to
Registry conditions: Subarachnoid Hemorrhage, Aneurysmal, Cerebrocardiac Syndrome, Mass Spectrometry, Heart Failure. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Multimodal Omics and Imaging Study on the Mechanisms of Brain-heart Injury in Patients With Intracranial Hemorrhage

Overview

Intracranial hemorrhage is a condition characterized by high mortality rates and suboptimal functional outcomes. It precipitates both direct brain injury and subsequent secondary injuries, including delayed cerebral ischemia, brain edema, and hydrocephalus. Complications such as cardiac injury may also arise, categorizing them within the cerebrocardiac syndrome (CCS). The clinical spectrum of CCS encompasses acute myocardial injury, acute coronary syndrome, left ventricular systolic and diastolic dysfunction, cardiac arrhythmias, and sudden cardiac death, all of which are associated with increased mortality and deterioration in patient status. The precise pathophysiological mechanisms underlying both cerebral and cardiac injuries remain enigmatic, and the implications for diagnosis and therapeutic strategies are yet to be fully explored. In this study, we propose to enroll patients with intracranial hemorrhage who will undergo conventional treatment and comprehensive multidisciplinary evaluations. Our observational research is grounded in a multimodal omics and imaging approach, aimed at investigating both local and systemic injuries subsequent to intracranial hemorrhage. This comprehensive strategy is intended to facilitate precise diagnosis, risk stratification, and clinical decision-making, while also shedding light on the pathophysiological mechanisms involved. The primary objectives of this research are to address the following key questions: * \[Question 1\] What are the pathophysiological mechanisms underlying cardiac injury in patients with intracranial hemorrhage? * \[Question 2\] What are the pathophysiological mechanisms responsible for early and delayed brain injuries following intracranial hemorrhage?\"

Interventions

  • Diagnostic test Multi-disciplinary assessment
    Multi-disciplinary assessment including blood tests, CSF test, electrocardiograms, ultrasound, imaging, etc

Primary outcome measures

  • Short-term cardiac events [Time frame: At discharge (assessed up to 5 days)]
  • Long-term cardiac events [Time frame: 3 months post-discharge]
  • Short-term delayed cerebral ischemia [Time frame: At discharge (assessed up to 5 days)]
  • Long-term delayed cerebral ishemia [Time frame: 3 months post-discharge]
  • Short-term brain-heart syndrome [Time frame: At discharge (assessed up to 5 days)]
  • Long-term brain-heart syndrome [Time frame: 3 months post-discharge]
Secondary outcome measures (2)
  • Short-term modified Rankin Scale scores [Time frame: At discharge (assessed up to 5 days)]
  • Long-term modified Rankin Scale scores [Time frame: 3 months post-discharge]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 years or older at the time of enrollment.
  • Acute intracranial hemorrhage confirmed by neuroimaging (CT, MRI，CTA, MRA, or DSA) within 48 hours of symptom onset.
  • Ability to provide informed consent or have a legally authorized representative willing to consent on their behalf.

Exclusion criteria

  • Patients who refuse to participate in the study or cannot provide informed consent.
  • Patients with a history of significant cardiovascular disease, including myocardial infarction, heart failure, or arrhythmias, unless stable and well-controlled.
  • Patients who have undergone cardiac bypass surgery, stent placement, or other cardiovascular interventions within the past 6 months.
  • Patients with active brain tumors, ischemic stroke within 3 months or a history of previous brain injury that could confound the study findings.
  • Patients with active malignant disease, severe inflammatory or infectious disease, or those who have undergone surgery for any reason within the past 3 months.
  • Patients with any condition that, in the opinion of the investigator, would make it unsafe or impractical to participate in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital Affiliated to Capital Medical University — Beijing

Identifiers

NCT: NCT06906432 · BHI2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗