ClinicalTrials.gg
RecruitingNCT06906432Updated Apr 2, 2025

Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage

An observational study in Subarachnoid Hemorrhage, Aneurysmal, Cerebrocardiac Syndrome and Mass Spectrometry, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by Beijing Tiantan Hospital · Observational

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study 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?\"
02

Conditions studied

  • 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
03

In context

Subarachnoid Hemorrhage

510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 120 across 226 observational studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 or have a legally authorized representative willing to consent on their behalf.

Exclusion criteria

Exclusion Criteria:

  1. Patients who refuse to participate in the study or cannot provide .
  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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • patients with intracranial hemorrhage

    patients with subarachnoid hemorrhage or intracerebral hemorrhage

    Diagnostic Test: Multi-disciplinary assessment

Interventions

  • Diagnostic testMulti-disciplinary assessment

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

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What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 3 months post-discharge

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 3 months post-discharge

Other outcomes

  1. Lower extremity deep venous thrombosis

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Dec 2034, 124 months after the start.

Of 116 non-industry observational studies under Subarachnoid Hemorrhage, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 127. This study's planned 124 months is above that.

Counting every sponsor, half of 119 studies reached it within 40 months; a quarter within 19 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2025
First posted
Apr 2, 2025
StartActual
Aug 1, 2024
Primary completionEst.
Dec 1, 2034
CompletionEst.
Dec 1, 2036
Last update
Apr 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06906432
Collaborators
Beijing Youyi Hospital, Tianjin Medical University General Hospital, First Affiliated Hospital of Fujian Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Gulou Hospital Affiliated to Medical College of Nanjing University
Responsible party
Dr. Yong Cao (Dr., Beijing Tiantan Hospital) — Principal investigator
First posted
Apr 2, 2025
Start date
Aug 1, 2024
Primary completion
Dec 1, 2034 (estimated)
Completion
Dec 1, 2036 (estimated)
Last update
Apr 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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