Clinical trial NCT06882577: Heart Evaluation of Acute Ischemic Stroke With Reperfusion Therapy
Official title: Heart Evaluation of Acute Ischemic Stroke With Reperfusion Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: Acute ischemic stroke
heart
Reperfusion Therapy
Lead sponsor: Soochow University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients within 24 h after onset of stroke-related symptoms.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Major Adverse Cardiovascular Events
timeFrame: 1 year
Secondary outcomes:
measure: Rate of Major Adverse Cardiovascular Events
timeFrame: 90 days
measure: Functional Outcome
timeFrame: 90 days
measure: Rate of Ischemic Stroke
timeFrame: 1 year
measure: Rate of Acute Coronary Syndrome
timeFrame: 1 year
measure: Rate of Cardiovascular Mortality
timeFrame: 1 year
measure: Time to First Major Adverse Cardiovascular Event
timeFrame: 3 years
measure: Time to First Ischemic Stroke
timeFrame: 3 years
measure: Rate of Major Adverse Cardiovascular Events
timeFrame: 3 years
measure: Rate of Ischemic Stroke
timeFrame: 3 years
measure: Rate of Acute Coronary Syndrome
timeFrame: 3 years
measure: Rate of Cardiovascular Mortality
timeFrame: 3 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The first affiliated hospital of soochow university
state: Jiangsu
Study officials:
References: