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

April 23, 2025 updated by: Chensheng Pan
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
658

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Department of Neurology, Tongji hospital, Tongji medical college, Huazhong University of Science and Technology
        • Contact:
        • Contact:
        • Contact:
          • Guo Li, PhD
        • Contact:
          • Chensheng Pan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
blood high-sensitivity cardiac troponin level
Time Frame: within 48 hours and at 72 hours after stroke onset
a marker of acute myocardial injury
within 48 hours and at 72 hours after stroke onset
left ventricular ejection fraction
Time Frame: within 1 week after stroke onset
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
Time Frame: within 1 week after stroke onset
a marker of ventricular dysfunction and heart failure
within 1 week after stroke onset
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.
3 months and 1 year after stroke onset.
death
Time Frame: 1 month, 3 months and 1 year after stroke onset
1 month, 3 months and 1 year after stroke onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
post-stroke cognitive impairment
Time Frame: 3 months and 1 year after stroke onset.
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
Time Frame: 3 months and 1 year after stroke onset.
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
Time Frame: 3 months and 1 year after stroke onset.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chensheng Pan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Natural Science Foundation of China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhou Zhu, MD, PhD, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Tech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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