NCT05631808

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 6, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 9, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

November 21, 2022

Last Update Submit

May 6, 2023

Conditions

Ischemic Stroke

Keywords

Ischemic strokeEpicardial adipose tissueObesity

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin scale (mRS)

    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 Outcomes (4)

  • Barthel Index (BI)

    90 days after stroke onset.

  • The change of NIHSS score

    7 days after stroke onset.

  • Hemorrhagic transformation

    within 7 days of symptom onset

  • Mortality

    within 7 days of symptom onset

Study Arms (3)

Lowest tertile

Participants with lowest tertile of EAT volume or attenuation among all eligible participants.

Other: Epicardial adipose tissue volume and attenuation

Intermediate tertile

Participants with intermediate tertile of EAT volume or attenuation among all eligible participants.

Other: Epicardial adipose tissue volume and attenuation

Highest tertile

Participants with highest tertile of EAT volume or attenuation among all eligible participants.

Other: Epicardial adipose tissue volume and attenuation

Interventions

Epicardial adipose tissue volume and attenuationOTHER

Epicardial adipose tissue volume and attenuation assessed by CT are the exposure factors in this study.

Highest tertileIntermediate tertileLowest tertile

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeObesity

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guogang Luo, MD, PhD

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guogang Luo, MD, PhD

CONTACT

0086-13991974085lguogang@163.com

Mengmeng Li

CONTACT

0086-178991095002921887723@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

November 30, 2022

Study Start

February 6, 2023

Primary Completion

December 1, 2024

Study Completion

March 1, 2025

Last Updated

May 9, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Locations

CN(1)