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NCT Number: NCT06906432

Mechanisms of Brain-Heart Injury of Post-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?"

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Key information

Conditions

Subarachnoid Hemorrhage, Aneurysmal Anxiety Disorders Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrocardiac Syndrome Cerebrovascular Disorders Delayed Cerebral Ischemia Heart Diseases Heart Failure Heart Infarction Hemorrhage Hydrocephalus Infarction Intracerebral Hemorrhage Intracranial Hemorrhages Ischemia Ischemic Heart Disease Mass Spectrometry Mental Disorders Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Neurocirculatory Asthenia Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases Vasospasm, Cerebral Vasospasm, Intracranial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Yong Cao, M.D.

CONTACT

[email protected]

861067096510 ext. 100070

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Multi-disciplinary assessment

Diagnostic Test

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

Primary outcomes

  1. Short-term cardiac events

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

    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.

  2. Long-term cardiac events

    Time frame: 3 months post-discharge

    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. Short-term delayed cerebral ischemia

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

    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).

  4. Long-term delayed cerebral ishemia

    Time frame: 3 months post-discharge

    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).

  5. Short-term brain-heart syndrome

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

    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).

  6. Long-term brain-heart syndrome

    Time frame: 3 months post-discharge

    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).

Secondary outcomes

  1. Short-term modified Rankin Scale scores

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

    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.

  2. Long-term modified Rankin Scale scores

    Time frame: 3 months post-discharge

    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.

Other outcomes

  1. Lower extremity deep venous thrombosis

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

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

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2034
Study completion
2036
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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