Mechanisms And Prognosis of Stroke-Heart Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChensheng Pan

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

Subjects will be selected from the neurology outpatient clinic, emergency department, and intensive care unit.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

blood high-sensitivity cardiac troponin level

a marker of acute myocardial injury

Time frame
within 48 hours and at 72 hours after stroke onset
2

left ventricular ejection fraction

measured by transthoracic echocardiography; a marker of ventricular dysfunction and heart failure

Time frame
within 1 week after stroke onset
3

blood N-terminal pro-brain natriuretic peptide (NT-proBNP) level

a marker of ventricular dysfunction and heart failure

Time frame
within 1 week after stroke onset
4

functional outcome

measured by modified Rankin scale (mRS), a 7-level ordinal scale (scores 0-6) used to assess global disability after stroke. Higher scores indicate worse functional outcome.

Time frame
3 months and 1 year after stroke onset.

Secondary outcomes

1

post-stroke cognitive impairment

measured by Montreal Cognitive Assessement (MoCA), a widely used screening tool designed to detect mild cognitive impairment and dementia. MoCA score range: 0-30, higher scores indicate better cognitive function.

Time frame
3 months and 1 year after stroke onset.
2

post-stroke depression

measured by Hamilton depression rating scale (HAMD), a widely used clinician-administered tool for assessing the severity of depression. HAMD score range: 0-52. Higher scores indicate higher depression severity.

Time frame
3 months and 1 year after stroke onset.
3

post-stroke anxiety

measured by Hamilton anxiety rating scale (HAMA), a clinician-administered tool to assess the severity of anxiety symptoms. HAMA score range: 0-56. Higher scores indicate higher anxiety severity.

Time frame
3 months and 1 year after stroke onset.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chensheng Pan

Lead sponsor

Tongji Hospital

Sponsor institution

National Natural Science Foundation of China

Collaborator