StrokeMAP-SHSNCT06954103
Mechanisms And Prognosis of Stroke-Heart Syndrome
An observational study of Stroke and Myocardial Injury, run by Chensheng Pan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Myocardial Injury, Heart Failure
- How many people
- 658 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected from the neurology outpatient clinic, emergency department, and intensive care unit.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Bai, +86 15994298517, tj_clinicaltrial@163.com
pancs29@gmail.com
About this study
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
- Keywords
- Stroke-heart syndrome
- Medical subject headings
- Stroke, Heart Failure, Acute Coronary Syndrome, Arrhythmias, Cardiac, Death, Sudden, Cardiac, Takotsubo Cardiomyopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
blood high-sensitivity cardiac troponin level
a marker of acute myocardial injury
Measured: 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
Measured: within 1 week after stroke onset
blood N-terminal pro-brain natriuretic peptide (NT-proBNP) level
a marker of ventricular dysfunction and heart failure
Measured: 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.
Measured: 3 months and 1 year after stroke onset.
death
Measured: 1 month, 3 months and 1 year after stroke onset
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 months and 1 year after stroke onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 658 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chensheng Pan
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Chensheng Pan, Tongji Hospital
- Investigators
- Zhou Zhu, MD, PhD, Principal investigator, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Tech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954103
- Sponsor's protocol ID
- TJ-IRB202502010
- Acronym
- MAP-SHS
- Status last verified
- Feb 2025
- First submitted
- 15 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms And Prognosis of Stroke-Heart Syndrome
- ClinicalTrials.gov ID
- NCT06954103
- Acronym / sponsor ID
- MAP-SHS / TJ-IRB202502010
- Conditions
- Stroke, Myocardial Injury, Heart Failure, Acute Coronary Syndromes, Arrhythmia, Sudden Cardiac Death
- Keywords
- Stroke-heart syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 658 participants (estimated)
- Lead sponsor
- Chensheng PanUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from the neurology outpatient clinic, emergency department, and intensive care unit.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood high-sensitivity cardiac troponin level
Time frame: within 48 hours and at 72 hours after stroke onset
a marker of acute myocardial injury
left ventricular ejection fraction
Time frame: within 1 week after stroke onset
measured by transthoracic echocardiography; a marker of ventricular dysfunction and heart failure
blood N-terminal pro-brain natriuretic peptide (NT-proBNP) level
Time frame: within 1 week after stroke onset
a marker of ventricular dysfunction and heart failure
functional outcome
Time frame: 3 months and 1 year after stroke onset.
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.
death
Time frame: 1 month, 3 months and 1 year after stroke onset
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhou Zhu, MD, PhD principal investigator
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Tech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Myocardial Injury, run by Chensheng Pan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chensheng Pan, M.D. (+8618202738845, pancs29@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood high-sensitivity cardiac troponin level (time frame: within 48 hours and at 72 hours after stroke onset). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.