Clinical trial NCT06906432: Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage
Official title: Multimodal Omics and Imaging Study on the Mechanisms of Brain-heart Injury in Patients With Intracranial Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Youyi Hospital
name: Tianjin Medical University General Hospital
name: First Affiliated Hospital of Fujian Medical University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Gulou Hospital Affiliated to Medical College of Nanjing University
First posted: 2025-04-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, we intend to enroll patients suffering from acute intracranial hemorrhage, who will undergo both conventional therapy and comprehensive multidisciplinary evaluations.

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?\&#34;


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.

Primary outcomes:
measure: Short-term cardiac events
timeFrame: At discharge (assessed up to 5 days)
measure: Long-term cardiac events
timeFrame: 3 months post-discharge
measure: Short-term delayed cerebral ischemia
timeFrame: At discharge (assessed up to 5 days)
measure: Long-term delayed cerebral ishemia
timeFrame: 3 months post-discharge
measure: Short-term brain-heart syndrome
timeFrame: At discharge (assessed up to 5 days)
measure: Long-term brain-heart syndrome
timeFrame: 3 months post-discharge
Secondary outcomes:
measure: Short-term modified Rankin Scale scores
timeFrame: At discharge (assessed up to 5 days)
measure: Long-term modified Rankin Scale scores
timeFrame: 3 months post-discharge
Other outcomes:
measure: Lower extremity deep venous thrombosis
timeFrame: At discharge (assessed up to 5 days)
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medical University
state: Beijing
Study officials:
References: