Mechanisms And Prognosis of Stroke-Heart Syndrome

NCT06954103 | Recruiting

• 1 other identifier: TJ-IRB202502010
• Study Type: observational
• Target: 658
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Myocardial Injury; Heart Failure; Acute Coronary Syndromes; Arrhythmia; Sudden Cardiac Death; Takotsubo Syndrome; Heart Rate Variability

Keywords

Stroke-heart syndrome

Outcome Measures

Primary Outcomes (5)

• blood high-sensitivity cardiac troponin level

  a marker of acute myocardial injury

  within 48 hours and at 72 hours after stroke onset

• left ventricular ejection fraction

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

  within 1 week after stroke onset

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

  a marker of ventricular dysfunction and heart failure

  within 1 week after stroke onset

• 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.

  3 months and 1 year after stroke onset.

• death

  1 month, 3 months and 1 year after stroke onset

Secondary Outcomes (3)

• post-stroke cognitive impairment

  3 months and 1 year after stroke onset.

• post-stroke depression

  3 months and 1 year after stroke onset.

• post-stroke anxiety

  3 months and 1 year after stroke onset.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chensheng Pan: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Department of Neurology, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma extracted from peripheral blood

MeSH Terms

Conditions

Stroke; Heart Failure; Acute Coronary Syndrome; Arrhythmias, Cardiac; Death, Sudden, Cardiac; Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Cardiomyopathies; Ventricular Dysfunction, Left; Ventricular Dysfunction

Study Officials

• Zhou Zhu, MD, PhD

  Tongji Hospital, Tongji Medical College, Huazhong University of Science and Tech

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chensheng Pan, M.D.

CONTACT

+8618202738845; pancs29@gmail.com

Zhou Zhu, MD, PhD

CONTACT

+86 18171081029; zhouzhu@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 1, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)