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Clinical Trials/NCT06882577
NCT06882577RecruitingNot Applicable

Heart Evaluation of Acute Ischemic Stroke With Reperfusion Therapy

Soochow University1 site in 1 country400 target enrollmentStarted: March 31, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
Rate of Major Adverse Cardiovascular Events

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • Rate of Ischemic Stroke(3 years)
  • Rate of Cardiovascular Mortality(3 years)
  • Rate of Major Adverse Cardiovascular Events(3 years)
  • Functional Outcome(90 days)
  • Rate of Acute Coronary Syndrome(3 years)
  • Time to First Major Adverse Cardiovascular Event(3 years)
  • Time to First Ischemic Stroke(3 years)

Investigators

Sponsor
Soochow University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jianqiang Ni

Clinical Professor

The First Affiliated Hospital of Soochow University

Study Sites (1)

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