Ischemic StrokeEATVASNCT05631808
Epicardial Adipose Tissue Volume and Attenuation in Acute Ischemic Stroke
An observational study of Ischemic Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Epicardial adipose tissue volume and attenuation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Guogang Luo, MD, PhD, 0086-13991974085, lguogang@163.com
About this study
Official title: 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.
- Conditions
- Ischemic Stroke
- Being tested
- Epicardial adipose tissue volume and attenuation
- Keywords
- Ischemic stroke, Epicardial adipose tissue, Obesity
- Medical subject headings
- Ischemic Stroke, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial adipose tissue volume and attenuationOther
Epicardial adipose tissue volume and attenuation assessed by CT are the exposure factors in this study.
| Study group | Role | What they receive |
|---|---|---|
| Lowest tertile | Participants with lowest tertile of EAT volume or attenuation among all eligible participants. Receives: Other: Epicardial adipose tissue volume and attenuation | |
| Intermediate tertile | Participants with intermediate tertile of EAT volume or attenuation among all eligible participants. Receives: Other: Epicardial adipose tissue volume and attenuation | |
| Highest tertile | Participants with highest tertile of EAT volume or attenuation among all eligible participants. Receives: Other: Epicardial adipose tissue volume and attenuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after stroke onset.
Secondary outcomes (4)
Barthel Index (BI)
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.
Measured: 90 days after stroke onset.
The change of NIHSS score
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.
Measured: 7 days after stroke onset.
Hemorrhagic transformation
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.
Measured: within 7 days of symptom onset
Mortality
We evaluate early mortality due to any cause within 7 days of symptom onset.
Measured: within 7 days of symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start6 Feb 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guogang Luo, MD, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631808
- Sponsor's protocol ID
- XJTU1AF2022LSK-348
- Acronym
- EATVAS
- Status last verified
- Apr 2023
- First submitted
- 21 Nov 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epicardial Adipose Tissue Volume and Attenuation on Clinical Outcomes After Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05631808
- Acronym / sponsor ID
- EATVAS / XJTU1AF2022LSK-348
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic stroke, Epicardial adipose tissue, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lowest tertile | – | Other: Epicardial adipose tissue volume and attenuationParticipants with lowest tertile of EAT volume or attenuation among all eligible participants. |
| Intermediate tertile | – | Other: Epicardial adipose tissue volume and attenuationParticipants with intermediate tertile of EAT volume or attenuation among all eligible participants. |
| Highest tertile | – | Other: Epicardial adipose tissue volume and attenuationParticipants with highest tertile of EAT volume or attenuation among all eligible participants. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epicardial adipose tissue volume and attenuationEpicardial adipose tissue volume and attenuation assessed by CT are the exposure factors in this study. | Other | Highest tertile, Intermediate tertile, Lowest tertile |
Primary outcome
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.
4 secondary outcomes
Barthel Index (BI)
Time frame: 90 days after stroke onset.
The change of NIHSS score
Time frame: 7 days after stroke onset.
Hemorrhagic transformation
Time frame: within 7 days of symptom onset
Mortality
Time frame: within 7 days of symptom onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guogang Luo, MD, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guogang Luo, MD, PhD (0086-13991974085, lguogang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin scale (mRS) (time frame: 90 days after stroke onset.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.