Mechanisms And Prognosis of Stroke-Heart Syndrome (MAP-SHS)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Stroke; Myocardial Injury; Arrhythmia; Sudden Cardiac Death; Heart Rate Variability; Acute Coronary Syndromes; Takotsubo Syndrome

• Study Type: Observational
• Enrollment (Estimated): 658

Contacts and Locations

• Study Contact: Name: Chensheng Pan, M.D.; Phone Number: +8618202738845; Email: pancs29@gmail.com
• Study Contact Backup: Name: Zhou Zhu, MD, PhD; Phone Number: +86 18171081029; Email: zhouzhu@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Department of Neurology, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology
      • Contact: Bai; Phone Number: +86 15994298517; Email: tj_clinicaltrial@163.com
      • Contact: Email: pancs29@gmail.com
      • Contact: Guo Li, PhD
      • Contact: Chensheng Pan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months and 1 year after stroke onset.
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.	3 months and 1 year after stroke onset.
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.	3 months and 1 year after stroke onset.

Collaborators and Investigators

• Sponsor: Chensheng Pan
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: Zhou Zhu, MD, PhD, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Tech

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Stroke-heart syndrome
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Cardiomyopathies; Ventricular Dysfunction; Myocardial Ischemia; Heart Arrest; Death, Sudden; Ventricular Dysfunction, Left; Stroke; Syndrome; Death, Sudden, Cardiac; Death; Acute Coronary Syndrome; Takotsubo Cardiomyopathy
• Other Study ID Numbers: TJ-IRB202502010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No