Clinical trial NCT05631808: Epicardial Adipose Tissue Volume and Attenuation in Acute Ischemic Stroke
Official title: Effect of Epicardial Adipose Tissue Volume and Attenuation on Clinical Outcomes After Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: Ischemic stroke
Epicardial adipose tissue
Obesity
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Modified Rankin scale (mRS)
timeFrame: 90 days after stroke onset.
Secondary outcomes:
measure: Barthel Index (BI)
timeFrame: 90 days after stroke onset.
measure: The change of NIHSS score
timeFrame: 7 days after stroke onset.
measure: Hemorrhagic transformation
timeFrame: within 7 days of symptom onset
measure: Mortality
timeFrame: within 7 days of symptom onset
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guogang Luo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: