Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage

NCT06906432 | Recruiting

• 1 other identifier: BHI2024
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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: 1. Electrocardiogram (ECG); 2. Cardiac biomarkers (e.g., troponin); 3. Echocardiography; 4. 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: 1. Head CT/MRI; 2. 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: 1. Head CT/MRI; 2. 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: 1. Electrocardiogram (ECG); 2. Cardiac enzyme tests (e.g., troponin, CK-MB); 3. Echocardiography; 4. Brain imaging (CT/MRI); 5. 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: 1. Electrocardiogram (ECG); 2. Cardiac enzyme tests (e.g., troponin, CK-MB); 3. Echocardiography; 4. Brain imaging (CT/MRI); 5. Biomarkers (e.g., BNP).

  3 months post-discharge

Secondary Outcomes (2)

• Short-term modified Rankin Scale scores

  At discharge (assessed up to 5 days)

• Long-term modified Rankin Scale scores

  3 months post-discharge

Other Outcomes (1)

• Lower extremity deep venous thrombosis

  At discharge (assessed up to 5 days)

Study Arms (1)

patients with intracranial hemorrhage

patients with subarachnoid hemorrhage or intracerebral hemorrhage

Diagnostic Test: Multi-disciplinary assessment

Interventions

Multi-disciplinary assessment DIAGNOSTIC_TEST

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

patients with intracranial hemorrhage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• 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

Study Sites (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and cerebrospinal fluid (CSF)

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Neurocirculatory Asthenia; Heart Failure; Atrial Fibrillation; Myocardial Ischemia; Myocardial Infarction; Arrhythmias, Cardiac; Hydrocephalus; Vasospasm, Intracranial; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anxiety Disorders; Mental Disorders; Heart Diseases; Infarction; Ischemia; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: April 2, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2036
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)