Epicardial Adipose Tissue Volume and Attenuation in Acute Ischemic Stroke (EATVAS)

May 6, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

Effect of Epicardial Adipose Tissue Volume and Attenuation on Clinical Outcomes After Acute Ischemic Stroke

Excessive accumulation or abnormal distribution of adipose tissue is a recognized risk factor for ischemic stroke. However, the impact of overweight or obesity on clinical outcomes of ischemic stroke is uncertain. The proposition of obesity paradox in stroke patients makes secondary prevention ambiguous for patients with ischemic stroke and overweight or obesity. Body mass index (BMI) or abdominal visceral fat area was used to measure obesity in previous studies. Epicardial adipose tissue (EAT) is a unique visceral fat, which has higher expression of proinflammatory genes than subcutaneous fat and abdominal visceral fat. And inflammation is closely related to the prognosis of ischemic stroke. In this study, the investigators assume EAT volume or attenuation evaluated by chest computed tomography (CT) scan might affect the prognosis of patients with acute ischemic stroke (AIS). Patients with the first acute ischemic stroke will be stratified into tertile groups based on EAT volume or attenuation. The primary endpoint measure is the proportion of patients with a favorable recovery of nerve function deficiency assessed by Modified Rankin Scale （mRS≤2） at 90 days after the onset of symptoms. Secondary endpoints include the following: the percentage of functional recovery measured by the Barthel Index (BI) at day 90 after stroke onset, the propotion of clinical improvement (with an improvement of ≥ 4 points on the National Institute of Health Stroke Scale score or the resolution of the neurologic deficit) or neurological deterioration (with a decline by ≥ 4 points in the total National Institute of Health Stroke Scale score) at day 7 after stroke onset, incidence of hemorrhagic transformation and mortality within 7 days of symptom onset.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

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

  • Name: Guogang Luo, MD, PhD
  • Phone Number: 0086-13991974085
  • Email: lguogang@163.com

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong 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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study intends to recruit 200 patients with the first acute ischemic stroke. They undergo chest CT scanning during hospitalization to evaluate epicardial adipose tissue volume and attenuation.

Description

Inclusion Criteria:

  • Patient is between 18 and 80 years of old;
  • Acute ischemic stroke（AIS）is diagnosed by brain imaging, and this is the first ischemic stroke event;
  • Patient is admitted to hospital within 72 hours after stroke onset;
  • Modified Rankin scale score (mRS) ≤2 before onset;
  • Patient undergoes chest CT scanning during hospitalization;
  • Provision of written informed consent.

Exclusion Criteria:

  • Pregnant or nursing women;
  • Complicated with cerebral hemorrhage showed by cranial CT on admission;
  • Patient had brain tumor, intracranial aneurysm, arteriovenous malformation, or cerebral hemorrhage or underwent brain surgery in the past;
  • Severe cardiac, liver, pulmonary, or kidney disease, malignancy, severe coagulation dysfunction, and systemic organ dysfunction;
  • Failure to accomplish 7-day and 3-month follow up.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lowest tertile
Participants with lowest tertile of EAT volume or attenuation among all eligible participants.
Other: Epicardial adipose tissue volume and attenuation
Epicardial adipose tissue volume and attenuation assessed by CT are the exposure factors in this study.
Intermediate tertile
Participants with intermediate tertile of EAT volume or attenuation among all eligible participants.
Other: Epicardial adipose tissue volume and attenuation
Epicardial adipose tissue volume and attenuation assessed by CT are the exposure factors in this study.
Highest tertile
Participants with highest tertile of EAT volume or attenuation among all eligible participants.
Other: Epicardial adipose tissue volume and attenuation
Epicardial adipose tissue volume and attenuation assessed by CT are the exposure factors in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin scale (mRS)
Time Frame: 90 days after stroke onset.
Assess patients' prognosis by the score of modified Rankin Scale. In the mRS, the lowest score is 0, the highest score is 6, and higher scores mean worse outcome. A score of 0 indicates the patients have no symptoms at all, and a score of 6 indicates the patients are dead. In this study, we evaluate patient's outcomes by the following criteria. A favorable outcome is defined as an mRS score of 0 to 2, an excellent outcome is defined as an mRS score of 0 to 1, whereas a poor outcome is defined as mRS>2.
90 days after stroke onset.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index (BI)
Time Frame: 90 days after stroke onset.
The percentage of functional recovery from baseline to 90 days after stroke onset, is measured by the Barthel Index (BI). BI score from 0-100, higher scores mean better outcome. We measure how many patients achieve 95 for the BI.
90 days after stroke onset.
The change of NIHSS score
Time Frame: 7 days after stroke onset.
The percentage of functional recovery or deterioration from baseline to 7 days after stroke onset, is measured by the National Institute of Health Stroke Scale, short for NIHSS. NIHSS score from 0-42, higher scores mean worse outcome. We define early functional improvement as an improvement of ≥ 4 points on the NIHSS or the resolution of the neurologic deficit, and early neurological deterioration as a decline by ≥ 4 points in the total NIHSS score within 7 days of symptom onset.
7 days after stroke onset.
Hemorrhagic transformation
Time Frame: within 7 days of symptom onset
Hemorrhagic transformation is considered present when follow-up MRI or CT scans reveal findings consistent with a newly developed extravasation of blood. Symptomatic intracranial hemorrhage is defined as extravascular blood in the brain confirmed by neuroimaging and is associated with neurological deterioration of ≥ 4 points on the NIHSS.
within 7 days of symptom onset
Mortality
Time Frame: within 7 days of symptom onset
We evaluate early mortality due to any cause within 7 days of symptom onset.
within 7 days of symptom onset

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Guogang Luo, MD, PhD, First Affiliated Hospital Xi'an Jiaotong 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)

February 6, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2022LSK-348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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