Heart Evaluation of Acute Ischemic Stroke With Reperfusion Therapy (HEART)

May 12, 2025 updated by: Jianqiang Ni, Soochow University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

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 Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Acute ischemic stroke patients within 24 h after onset of stroke-related symptoms.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart Evaluation of Acute ischemic stroke with Reperfusion Therapy
Acute ischemic stroke within 24 h after onset of stroke-related symptoms.
Other: observational only- no intervention
observational only- no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcome
Time Frame: 90 days
Percentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled.
90 days
Rate of Ischemic Stroke
Time Frame: 1 year
fatal and nonfatal ischemic stroke.
1 year
Rate of Acute Coronary Syndrome
Time Frame: 1 year
fatal and nonfatal myocardial infarction and unstable angina
1 year
Rate of Cardiovascular Mortality
Time Frame: 1 year
any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
1 year
Rate of Major Adverse Cardiovascular Events
Time Frame: 90 days
ardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
90 days
Time to First Major Adverse Cardiovascular Event
Time Frame: 3 years
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
3 years
Time to First Ischemic Stroke
Time Frame: 3 years
from the date of enrollment until the date of first documented ischemic stroke, assessed up to 3 years
3 years
Rate of Major Adverse Cardiovascular Events
Time Frame: 3 years
cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina
3 years
Rate of Ischemic Stroke
Time Frame: 3 years
fatal and nonfatal ischemic stroke
3 years
Rate of Acute Coronary Syndrome
Time Frame: 3 years
fatal and nonfatal myocardial infarction and unstable angina
3 years
Rate of Cardiovascular Mortality
Time Frame: 3 years
any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death
3 years

Collaborators and Investigators

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

Sponsor

Soochow University

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)

March 31, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 16, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025PJ160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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