AzTrials
AzTrials

Subarachnoid Hemorrhage, AneurysmalNCT06906432

Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage

An observational study of Subarachnoid Hemorrhage, Aneurysmal and Cerebrocardiac Syndrome, run by Beijing Tiantan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Multi-disciplinary assessment
How many people
1,000 participants
Where
1 siteChina
Study dates
1 Aug 2024to 1 Dec 2036
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Beijing Tiantan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100070

    Yong Cao, M.D., 861067096510 ext. 100070, caoyong@bjtth.org

    Recruiting

Other trials in China

About this study

Official title: 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.

Read more

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?\"
Being tested
Multi-disciplinary assessment
Medical subject headings
Subarachnoid Hemorrhage, Neurocirculatory Asthenia, Heart Failure, Atrial Fibrillation, Myocardial Ischemia, Myocardial Infarction, Arrhythmias, Cardiac, Hydrocephalus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-disciplinary assessmentDiagnostic test

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

Study groups in NCT06906432
Study groupRoleWhat they receive
patients with intracranial hemorrhagepatients with subarachnoid hemorrhage or intracerebral hemorrhage
Receives: Diagnostic Test: Multi-disciplinary assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At discharge (assessed up to 5 days)

  2. 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.

    Measured: 3 months post-discharge

  3. 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).

    Measured: At discharge (assessed up to 5 days)

  4. 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).

    Measured: 3 months post-discharge

  5. 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).

    Measured: At discharge (assessed up to 5 days)

  6. 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).

    Measured: 3 months post-discharge

Secondary outcomes (2)

  1. 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.

    Measured: At discharge (assessed up to 5 days)

  2. 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.

    Measured: 3 months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start1 Aug 2024
  3. Primary completion1 Dec 2034 (estimated)
  4. Study completion1 Dec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06906432
Sponsor's protocol ID
BHI2024
Status last verified
Mar 2025
First submitted
11 Feb 2025
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage, Aneurysmal and Cerebrocardiac Syndrome, run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short-term cardiac events (time frame: At discharge (assessed up to 5 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06906432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in