Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage

NCT ID: NCT06906432

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2036-12-01

Brief Summary

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?"

Conditions

Subarachnoid Hemorrhage, Aneurysmal; Cerebrocardiac Syndrome; Mass Spectrometry; Heart Failure; Atrial Fibrillation; Ischemic Heart Disease; Heart Infarction; Arrhythmias, Cardiac; Delayed Cerebral Ischemia; Hydrocephalus; Vasospasm, Cerebral; Intracerebral Hemorrhage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with intracranial hemorrhage

patients with subarachnoid hemorrhage or intracerebral hemorrhage

Multi-disciplinary assessment

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Multi-disciplinary assessment

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Patients aged 18 years or older at the time of enrollment.

2. Acute intracranial hemorrhage confirmed by neuroimaging (CT, MRI，CTA, MRA, or DSA) within 48 hours of symptom onset.

3. Ability to provide informed consent or have a legally authorized representative willing to consent on their behalf.

Exclusion Criteria

1. Patients who refuse to participate in the study or cannot provide informed consent.

2. Patients with a history of significant cardiovascular disease, including myocardial infarction, heart failure, or arrhythmias, unless stable and well-controlled.

3. Patients who have undergone cardiac bypass surgery, stent placement, or other cardiovascular interventions within the past 6 months.

4. Patients with active brain tumors, ischemic stroke within 3 months or a history of previous brain injury that could confound the study findings.

5. Patients with active malignant disease, severe inflammatory or infectious disease, or those who have undergone surgery for any reason within the past 3 months.

6. Patients with any condition that, in the opinion of the investigator, would make it unsafe or impractical to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Youyi Hospital

UNKNOWN

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Gulou Hospital Affiliated to Medical College of Nanjing University

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Yong Cao

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yong Cao, M.D.

Role: primary

caoyong@bjtth.org

861067096510 ext. 100070

Other Identifiers

BHI2024

Identifier Type: -

Identifier Source: org_study_id