Acute Ischemic StrokeHEARTNCT06882577
Heart Evaluation of Acute Ischemic Stroke With Reperfusion Therapy
An observational study of Acute Ischemic Stroke, run by Soochow University at 1 site in China.
Trial summary
Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy (HEART) is a single-center observational registry evaluating the heart of patients hospitalized for acute ischemic stroke with reperfusion therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Mar 2029
- How long will I take part?
- 12 Months
- 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: Acute ischemic stroke patients within 24 h after onset of stroke-related symptoms.
Who may be able to join
- Written informed consent by patient
- Age ≥ 18 years
- Acute ischemic stroke (with matching brain lesion on MR imaging)
- Enrolment within 24 h after onset of stroke-related symptoms.
Who cannot join
- Pregnancy and / or breast-feeding.
- Participation in an interventional study.
- Patients refuse to participate in the research.
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
The first affiliated hospital of soochow university
Suzhou, Jiangsu, 215000
Jianqiang Ni, MD, PhD, +8617640052675, buildingdoc@163.com
About this study
Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy (HEART) is a single-center observational registry evaluating the heart of patients hospitalized for acute ischemic stroke with reperfusion therapy.
This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.
Read the detailed description
There is growing evidence pointing to close interactions between acute ischemic stroke (AIS) and heart diseases. Heart diseases may lead to AIS (heart-to-brain interactions), with many cardiac conditions have been proposed as potential sources of cerebral embolism, and studies have also shown that AIS can induce cardiac injury (brain-to-heart interactions), namely Stroke-Heart Syndrome. In addition, due to the commonly shared risk factors, AIS patients had a significantly higher frequency of coexisting prior known or unknown coronary heart disease (brain-and-heart interactions). These heart problems not only add complexity to the etiological diagnosis but also account for a great proportionate mortality in AIS patients with reperfusion therapy, which is the most effective treatment method for AIS. The interconnected and coexisting properties of AIS and heart diseases requires a comprehensive scheme to evaluate, prevent, and treat patients.
Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy (HEART) is a single-center observational registry evaluating the heart of patients hospitalized for acute ischemic stroke with reperfusion therapy.
This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.
The clinical, laboratory and imaging information will be collected at the baseline. During an estimated 3-year follow-up, the diagnostic or monitoring procedures, treatment, functional status and new vascular events will be recorded by web-based patients' self-reports, investigators' regular telephone visits.
- Conditions
- Acute Ischemic Stroke
- Being tested
- observational only- no intervention
- Keywords
- Acute ischemic stroke, heart, Reperfusion Therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational only- no interventionOther
observational only- no intervention
| Study group | Role | What they receive |
|---|---|---|
| Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy | Acute ischemic stroke within 24 h after onset of stroke-related symptoms. Receives: Other: observational only- no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Cardiovascular Events
cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
Measured: 1 year
Secondary outcomes (11)
Rate of Major Adverse Cardiovascular Events
ardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
Measured: 90 days
Functional Outcome
Percentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled.
Measured: 90 days
Rate of Ischemic Stroke
fatal and nonfatal ischemic stroke.
Measured: 1 year
Rate of Acute Coronary Syndrome
fatal and nonfatal myocardial infarction and unstable angina
Measured: 1 year
Rate of Cardiovascular Mortality
any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
Measured: 1 year
Time to First Major Adverse Cardiovascular Event
from the date of enrollment until the date of first documented cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction or unstable angina, whichever comes first, assessed up to 3 years
Measured: 3 years
Time to First Ischemic Stroke
from the date of enrollment until the date of first documented ischemic stroke, assessed up to 3 years
Measured: 3 years
Rate of Major Adverse Cardiovascular Events
cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
Measured: 3 years
Rate of Ischemic Stroke
fatal and nonfatal ischemic stroke
Measured: 3 years
Rate of Acute Coronary Syndrome
fatal and nonfatal myocardial infarction and unstable angina
Measured: 3 years
Rate of Cardiovascular Mortality
any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start31 Mar 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianqiang Ni, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882577
- Sponsor's protocol ID
- 2025PJ160
- Acronym
- HEART
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Evaluation of Acute Ischemic Stroke With Reperfusion Therapy
- ClinicalTrials.gov ID
- NCT06882577
- Acronym / sponsor ID
- HEART / 2025PJ160
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, heart, Reperfusion Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Soochow UniversityUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 18 Mar 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.
Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy (HEART) is a single-center observational registry evaluating the heart of patients hospitalized for acute ischemic stroke with reperfusion therapy.
This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.
Detailed description
There is growing evidence pointing to close interactions between acute ischemic stroke (AIS) and heart diseases. Heart diseases may lead to AIS (heart-to-brain interactions), with many cardiac conditions have been proposed as potential sources of cerebral embolism, and studies have also shown that AIS can induce cardiac injury (brain-to-heart interactions), namely Stroke-Heart Syndrome. In addition, due to the commonly shared risk factors, AIS patients had a significantly higher frequency of coexisting prior known or unknown coronary heart disease (brain-and-heart interactions). These heart problems not only add complexity to the etiological diagnosis but also account for a great proportionate mortality in AIS patients with reperfusion therapy, which is the most effective treatment method for AIS. The interconnected and coexisting properties of AIS and heart diseases requires a comprehensive scheme to evaluate, prevent, and treat patients.
Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy (HEART) is a single-center observational registry evaluating the heart of patients hospitalized for acute ischemic stroke with reperfusion therapy.
This registry aims to establish quantified risk stratification and prognostic models, as well as suggest effective diagnostic and therapeutic strategies.
The clinical, laboratory and imaging information will be collected at the baseline. During an estimated 3-year follow-up, the diagnostic or monitoring procedures, treatment, functional status and new vascular events will be recorded by web-based patients' self-reports, investigators' regular telephone visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy | – | Other: observational only- no interventionAcute ischemic stroke within 24 h after onset of stroke-related symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients within 24 h after onset of stroke-related symptoms.
Key inclusion criteria (4 listed)
- Written informed consent by patient
- Age ≥ 18 years
- Acute ischemic stroke (with matching brain lesion on MR imaging)
- Enrolment within 24 h after onset of stroke-related symptoms.
Key exclusion criteria (3 listed)
- Pregnancy and / or breast-feeding.
- Participation in an interventional study.
- Patients refuse to participate in the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational only- no interventionobservational only- no intervention | Other | Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy |
Primary outcome
Rate of Major Adverse Cardiovascular Events
Time frame: 1 year
cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
11 secondary outcomes
Rate of Major Adverse Cardiovascular Events
Time frame: 90 days
Functional Outcome
Time frame: 90 days
Rate of Ischemic Stroke
Time frame: 1 year
Rate of Acute Coronary Syndrome
Time frame: 1 year
Rate of Cardiovascular Mortality
Time frame: 1 year
Time to First Major Adverse Cardiovascular Event
Time frame: 3 years
Time to First Ischemic Stroke
Time frame: 3 years
Rate of Major Adverse Cardiovascular Events
Time frame: 3 years
Rate of Ischemic Stroke
Time frame: 3 years
Rate of Acute Coronary Syndrome
Time frame: 3 years
Rate of Cardiovascular Mortality
Time frame: 3 years
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 13 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Acute Ischemic Stroke, run by Soochow University 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 4 inclusion and 3 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 13 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 Jianqiang Ni, MD, PhD (+8617640052675, buildingdoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Major Adverse Cardiovascular Events (time frame: 1 year). 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 13 May 2025.