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Recruiting NCT06954103

Mechanisms And Prognosis of Stroke-Heart Syndrome

Observational Stroke Myocardial Injury Heart Failure Acute Coronary Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke, Myocardial Injury, Heart Failure, Acute Coronary Syndromes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The incidence of stroke-heart syndrome following acute stroke, which encompasses both acute ischemic stroke and acute intracerebral hemorrhage, is notably high and is strongly associated with increased mortality and poor outcomes in stroke patients. However, the underlying mechanisms remain unclear, and there are currently no effective prevention or treatment strategies. This study aims to elucidate the neuro-humoral mechanisms of stroke-heart syndrome through multimodal imaging and multi-omics blood analysis. Additionally, it seeks to observe the progression of stroke-heart syndrome and its impact on functional outcomes, cognitive abilities, and emotional issues post-stroke. The research is expected to uncover novel blood biomarkers and brain network mechanisms associated with stroke-heart syndrome, providing potential targets and theoretical foundations for pharmacological treatments or physical interventions. Furthermore, it aims to establish a risk early-warning system for major cardiovascular complications post-stroke, enabling early identification, early intervention, and integrated brain-heart management to improve clinical outcomes for stroke patients.

Primary outcome measures

  • blood high-sensitivity cardiac troponin level [Time frame: within 48 hours and at 72 hours after stroke onset]
  • left ventricular ejection fraction [Time frame: within 1 week after stroke onset]
  • blood N-terminal pro-brain natriuretic peptide (NT-proBNP) level [Time frame: within 1 week after stroke onset]
  • functional outcome [Time frame: 3 months and 1 year after stroke onset.]
  • death [Time frame: 1 month, 3 months and 1 year after stroke onset]
Secondary outcome measures (3)
  • post-stroke cognitive impairment [Time frame: 3 months and 1 year after stroke onset.]
  • post-stroke depression [Time frame: 3 months and 1 year after stroke onset.]
  • post-stroke anxiety [Time frame: 3 months and 1 year after stroke onset.]

Eligibility criteria

Inclusion criteria

  • Patients admitted within 48 hours of onset, confirmed by CT/MRI as having a stroke (including acute ischemic stroke and hemorrhagic stroke).
  • Moderate-to-severe stroke with NIHSS ≥ 5.

Exclusion criteria

  • Previous focal brain injury (such as stroke, brain surgery, traumatic brain injury, etc.).
  • Brain dysfunction caused by other major neurological disorders than stroke (such as brain tumors, epilepsy, Parkinson's disease, etc.).
  • Transient ischemic attack (TIA) and subarachnoid hemorrhage (SAH).
  • History of cardiac diseases (such as coronary heart disease, heart failure, severe arrhythmias, congenital heart disease, cardiac surgery, valvular heart disease, or undiagnosed significant cardiac symptoms).
  • Concomitant systemic diseases such as renal failure (eGFR < 30), autoimmune disorders, severe infections, etc.
  • History of dementia, depression, or other psychiatric disorders.
  • Poor compliance and inability to cooperate with follow-up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Neurology, Tongji hospital, Tongji medical college, Huazhong University of S — Wuhan

Identifiers

NCT: NCT06954103 · TJ-IRB202502010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗