Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06882577

Heart Evaluation of Acute Ischemic Stroke With Reperfusion Therapy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The first affiliated hospital of soochow university

Suzhou, Jiangsu, 215000, China

Location status: Recruiting

Location contact

Jianqiang Ni, MD, PhD

CONTACT

[email protected]

+8617640052675

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

observational only- no intervention

Other

observational only- no intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. Rate of Ischemic Stroke

    Time frame: 1 year

    fatal and nonfatal ischemic stroke.

  4. Rate of Acute Coronary Syndrome

    Time frame: 1 year

    fatal and nonfatal myocardial infarction and unstable angina

  5. Rate of Cardiovascular Mortality

    Time frame: 1 year

    any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death

  6. 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

  7. 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

  8. 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

  9. Rate of Ischemic Stroke

    Time frame: 3 years

    fatal and nonfatal ischemic stroke

  10. Rate of Acute Coronary Syndrome

    Time frame: 3 years

    fatal and nonfatal myocardial infarction and unstable angina

  11. Rate of Cardiovascular Mortality

    Time frame: 3 years

    any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death

Study contacts

Contact information is provided by the study sponsor or research team.

Jianqiang Ni, MD, PhD

CONTACT

[email protected]

+8617640052675

Sponsors and collaborators

Lead sponsor

Soochow University

Other

Registry information

Acronym: HEART

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Mar 18, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.