Clinical trial NCT06954103: Mechanisms And Prognosis of Stroke-Heart Syndrome
Official title: Mechanisms And Prognosis of Stroke-Heart Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Myocardial Injury
Heart Failure
Acute Coronary Syndromes
Arrhythmia
Sudden Cardiac Death
Takotsubo Syndrome
Heart Rate Variability
Keywords: Stroke-heart syndrome
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2025-05-01
Enrollment: 658
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be selected from the neurology outpatient clinic, emergency department, and intensive care unit.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Previous focal brain injury (such as stroke, brain surgery, traumatic brain injury, etc.).
2. Brain dysfunction caused by other major neurological disorders than stroke (such as brain tumors, epilepsy, Parkinson's disease, etc.).
3. Transient ischemic attack (TIA) and subarachnoid hemorrhage (SAH).
4. 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).
5. Concomitant systemic diseases such as renal failure (eGFR \< 30), autoimmune disorders, severe infections, etc.
6. History of dementia, depression, or other psychiatric disorders.
7. Poor compliance and inability to cooperate with follow-up.

Primary outcomes:
measure: blood high-sensitivity cardiac troponin level
timeFrame: within 48 hours and at 72 hours after stroke onset
measure: left ventricular ejection fraction
timeFrame: within 1 week after stroke onset
measure: blood N-terminal pro-brain natriuretic peptide (NT-proBNP) level
timeFrame: within 1 week after stroke onset
measure: functional outcome
timeFrame: 3 months and 1 year after stroke onset.
measure: death
timeFrame: 1 month, 3 months and 1 year after stroke onset
Secondary outcomes:
measure: post-stroke cognitive impairment
timeFrame: 3 months and 1 year after stroke onset.
measure: post-stroke depression
timeFrame: 3 months and 1 year after stroke onset.
measure: post-stroke anxiety
timeFrame: 3 months and 1 year after stroke onset.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Neurology, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Tech
name: Zhou Zhu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: