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Heart Evaluation of Acute Ischemic Stroke With Reperfusion Therapy

Heart Evaluation of Acute Ischemic Stroke With Reperfusion Therapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06882577
Acronym
HEART
Enrollment
400
Registered
2025-03-18
Start date
2025-03-31
Completion date
2029-03-31
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke, heart, Reperfusion Therapy

Brief 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. 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.

Interventions

observational only- no intervention

Sponsors

Soochow University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Written informed consent by patient 2. Age ≥ 18 years 3. Acute ischemic stroke (with matching brain lesion on MR imaging) 4. Enrolment within 24 h after onset of stroke-related symptoms.

Exclusion criteria

1. Pregnancy and / or breast-feeding. 2. Participation in an interventional study. 3. Patients refuse to participate in the research.

Design outcomes

Primary

MeasureTime frameDescription
Rate of Major Adverse Cardiovascular Events1 yearcardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina

Secondary

MeasureTime frameDescription
Rate of Ischemic Stroke1 yearfatal and nonfatal ischemic stroke.
Rate of Acute Coronary Syndrome1 yearfatal and nonfatal myocardial infarction and unstable angina
Rate of Cardiovascular Mortality1 yearany mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
Functional Outcome90 daysPercentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled.
Time to First Major Adverse Cardiovascular Event3 yearsfrom 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
Time to First Ischemic Stroke3 yearsfrom the date of enrollment until the date of first documented ischemic stroke, assessed up to 3 years
Rate of Major Adverse Cardiovascular Events90 daysardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina

Countries

China

Contacts

Primary ContactJianqiang Ni, MD, PhD
buildingdoc@163.com+8617640052675

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026