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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06906432
Enrollment
1000
Registered
2025-04-02
Start date
2024-08-01
Completion date
2036-12-01
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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?"

Interventions

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

Sponsors

Beijing Youyi Hospital
CollaboratorUNKNOWN
Tianjin Medical University General Hospital
CollaboratorOTHER
First Affiliated Hospital of Fujian Medical University
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
CollaboratorOTHER
Gulou Hospital Affiliated to Medical College of Nanjing University
CollaboratorUNKNOWN
Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Long-term brain-heart syndrome3 months post-dischargeParticipants 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).
Short-term delayed cerebral ischemiaAt 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: 1. Head CT/MRI; 2. Transcranial doppler sonography (TCD).
Long-term delayed cerebral ishemia3 months post-dischargeParticipants 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).
Short-term brain-heart syndromeAt 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: 1. Electrocardiogram (ECG); 2. Cardiac enzyme tests (e.g., troponin, CK-MB); 3. Echocardiography; 4. Brain imaging (CT/MRI); 5. Biomarkers (e.g., BNP).
Short-term cardiac eventsAt 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: 1. Electrocardiogram (ECG); 2. Cardiac biomarkers (e.g., troponin); 3. Echocardiography; 4. Holter monitoring.
Long-term cardiac events3 months post-dischargeParticipants 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.

Secondary

MeasureTime frameDescription
Short-term modified Rankin Scale scoresAt 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.
Long-term modified Rankin Scale scores3 months post-dischargeThe 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

MeasureTime frameDescription
Lower extremity deep venous thrombosisAt discharge (assessed up to 5 days)Participants who suffer from lower extremity deep venous thrombosis confirmed by lower vein ultrasound.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026