Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital

About this trial

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?\"

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

In this study, we intend to enroll patients suffering from acute intracranial hemorrhage, who will undergo both conventional therapy and comprehensive multidisciplinary evaluations.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Multi-disciplinary assessment

    Diagnostic test

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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: patients with intracranial hemorrhage1 intervention

Trial outcomes

Primary outcomes

1

Short-term cardiac events

Participants who suffer from sudden dysfunction or structural abnormalities of the heart (e.g., arrhythmias, myocardial infarct, sudden death) confirmed through: 1. Electrocardiogram (ECG); 2. Cardiac biomarkers (e.g., troponin); 3. Echocardiography; 4. Holter monitoring.

Time frame
At discharge (assessed up to 5 days)
2

Long-term cardiac events

Participants who suffer from sudden dysfunction or structural abnormalities of the heart (e.g., arrhythmias, myocardial infarct, sudden death) confirmed through: 1. Electrocardiogram (ECG); 2. Cardiac biomarkers (e.g., troponin); 3. Echocardiography; 4. Holter monitoring.

Time frame
3 months post-discharge
3

Short-term delayed cerebral ischemia

Participants who suffer from secondary reduction in cerebral blood flow due to mechanisms such as vasospasm, microthrombosis, or hemodynamic disturbances, confirmed through: 1. Head CT/MRI; 2. Transcranial doppler sonography (TCD).

Time frame
At discharge (assessed up to 5 days)
4

Long-term delayed cerebral ishemia

Participants who suffer from secondary reduction in cerebral blood flow due to mechanisms such as vasospasm, microthrombosis, or hemodynamic disturbances, confirmed through: 1. Head CT/MRI; 2. Transcranial doppler sonography (TCD).

Time frame
3 months post-discharge

Secondary outcomes

1

Short-term modified Rankin Scale scores

The modified Rankin Scale (mRS) scores of participants evaluated by specialists. The mRS scores range form 0 to 6, with higher scores indicating worse outcomes.

Time frame
At discharge (assessed up to 5 days)
2

Long-term modified Rankin Scale scores

The modified Rankin Scale (mRS) scores of participants evaluated by specialists. The mRS scores range form 0 to 6, with higher scores indicating worse outcomes.

Time frame
3 months post-discharge

Other outcomes

1

Lower extremity deep venous thrombosis

Participants who suffer from lower extremity deep venous thrombosis confirmed by lower vein ultrasound.

Time frame
At discharge (assessed up to 5 days)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Beijing Youyi Hospital

Collaborator

Tianjin Medical University General Hospital

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator

Gulou Hospital Affiliated to Medical College of Nanjing University

Collaborator