Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage

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

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?"

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Atrial Fibrillation; Arrhythmias, Cardiac; Ischemic Heart Disease; Subarachnoid Hemorrhage, Aneurysmal; Delayed Cerebral Ischemia; Intracerebral Hemorrhage; Hydrocephalus; Vasospasm, Cerebral; Heart Infarction; Mass Spectrometry; Cerebrocardiac Syndrome
• Intervention / Treatment: Diagnostic test: Multi-disciplinary assessment

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital Affiliated to Capital Medical University
      • Contact: Yong Cao, M.D.; Phone Number: 100070 861067096510; Email: caoyong@bjtth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with intracranial hemorrhage; patients with subarachnoid hemorrhage or intracerebral hemorrhage	Diagnostic test: Multi-disciplinary assessment; Multi-disciplinary assessment including blood tests, CSF test, electrocardiograms, ultrasound, imaging, etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Electrocardiogram (ECG);; Cardiac biomarkers (e.g., troponin);; Echocardiography;; Holter monitoring.	At discharge (assessed up to 5 days)
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: Electrocardiogram (ECG);; Cardiac biomarkers (e.g., troponin);; Echocardiography;; Holter monitoring.	3 months post-discharge
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: Head CT/MRI;; Transcranial doppler sonography (TCD).	At discharge (assessed up to 5 days)
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: Head CT/MRI;; Transcranial doppler sonography (TCD).	3 months post-discharge
Short-term brain-heart syndrome	Participants who suffer from cardiac dyafunction triggered by cerebral hemorrhage. Clinical manifestations include ECG abnormalities (ST-T changes, prolonged QT interval, arrhythmias), elevated cardiac enzymes (e.g., troponin), cardiac insufficiency (e.g., heart failure, pulmonary edema), chest pain mimicking myocardial ischemia and myocardial infarct. Some patients may develop life-threatening arrhythmias (e.g., ventricular fibrillation). Diagnostic evaluations involve: Electrocardiogram (ECG);; Cardiac enzyme tests (e.g., troponin, CK-MB);; Echocardiography;; Brain imaging (CT/MRI);; Biomarkers (e.g., BNP).	At discharge (assessed up to 5 days)
Long-term brain-heart syndrome	Participants who suffer from cardiac dyafunction triggered by cerebral hemorrhage. Clinical manifestations include ECG abnormalities (ST-T changes, prolonged QT interval, arrhythmias), elevated cardiac enzymes (e.g., troponin), cardiac insufficiency (e.g., heart failure, pulmonary edema), chest pain mimicking myocardial ischemia and myocardial infarct. Some patients may develop life-threatening arrhythmias (e.g., ventricular fibrillation). Diagnostic evaluations involve: Electrocardiogram (ECG);; Cardiac enzyme tests (e.g., troponin, CK-MB);; Echocardiography;; Brain imaging (CT/MRI);; Biomarkers (e.g., BNP).	3 months post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At discharge (assessed up to 5 days)
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.	3 months post-discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lower extremity deep venous thrombosis	Participants who suffer from lower extremity deep venous thrombosis confirmed by lower vein ultrasound.	At discharge (assessed up to 5 days)

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University; First Affiliated Hospital of Fujian Medical University; Tianjin Medical University General Hospital; Beijing Youyi Hospital; Gulou Hospital Affiliated to Medical College of Nanjing University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Wounds and Injuries; Pathologic Processes; Heart Diseases; Brain Infarction; Infarction; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Ischemia; Stroke; Thoracic Injuries; Anxiety Disorders; Cerebral Infarction; Atrial Fibrillation; Coronary Artery Disease; Myocardial Ischemia; Hemorrhage; Cerebral Hemorrhage; Subarachnoid Hemorrhage; Brain Ischemia; Arrhythmias, Cardiac; Hydrocephalus; Intracranial Hemorrhages; Vasospasm, Intracranial; Heart Injuries; Neurocirculatory Asthenia
• Other Study ID Numbers: BHI2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No