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Stroke, IschemicNCT06165107

The Association Between Obesity-Related Indicators and Adverse Outcomes in Ischemic Stroke Patients

An observational study of Stroke, Ischemic, run by Qin Zhang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study encompasses two cohorts: a retrospective cohort derived from a genuine clinical environment and a national multicenter prospective cohort for secondary analysis. Initially, a retrospective cohort study was conducted to investigate the impact of metabolic syndrome on the prognosis of stroke patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Ischemic
How many people
18,374 participants
Where
1 siteChina
Study dates
1 Sep 2000to 31 Jan 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study encompasses two cohorts: a retrospective cohort derived from a genuine clinical environment and a national multicenter prospective cohort. Initially, a retrospective cohort study was conducted to investigate the impact of metabolic syndrome on the prognosis of stroke patients. Following this, a prospective cohort study was conducted to examine the relationships among metabolic syndrome, potential causative molecules, and adverse outcomes in stroke patients, as previously reported(Annals of Neurology 2011, 70(2):265-273; Lipids in Health and Disease 2024, 23(1)).

Who may be able to join

  • Patients experiencing their first-ever stroke. Cases of spontaneous intracerebral hemorrhage (ICH) or ischemic stroke (IS). Patients who underwent head computed tomography and/or cranial magnetic resonance imaging within 24 hours of symptom onset.
  • Diagnosis of metabolic syndrome (MetS) according to the criteria established by the Chinese Diabetes Society (CDS) in 2004.

Who cannot join

  • Individuals under 18 years of age. Pregnant women.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Obesity and Stroke: Exploring the Clinical Connection Through Epidemiology and Molecular Medicine

This study encompasses two cohorts: a retrospective cohort derived from a genuine clinical environment and a national multicenter prospective cohort for secondary analysis. Initially, a retrospective cohort study was conducted to investigate the impact of metabolic syndrome on the prognosis of stroke patients. Following this, a prospective cohort study was conducted to examine the relationships among metabolic syndrome, potential causative molecules, and adverse outcomes in stroke patients, as previously reported(Annals of Neurology 2011, 70(2):265-273; Lipids in Health and Disease 2024, 23(1)). Additionally, the study explored potential mediating effects among these factors. The study population comprised patients experiencing acute first-ever ischemic stroke, with diagnostic criteria established according to the International Classification of Diseases, Ninth Revision. All subjects presented conclusive neuroimaging evidence, including head computed tomography and/or magnetic resonance imaging, which was reviewed by two or more experienced neuroradiologists. Adverse outcomes were characterized as compliant endpoint events, including mortality and recurrences. The primary outcome was adverse outcomes, while the secondary outcome was recurrence-free survival (RFS).

Read the detailed description

Clinical data for the derivation cohort were acquired from three medical facilities: Tongji Hospital Sino-French New City Branch in Caidian District, Tongji Hospital Qiaokou Branch in Hankou District, and Tongji Hospital Optics Valley Branch in Wuhan East Lake High-Tech Development Zone. The clinical data were sourced from the electronic medical records of Tongji Hospital, the largest healthcare facility in the Hubei region of China. Its comprehensive electronic medical record system comprises over 60 million medical records spanning from 1980 to the present. We retrospectively gathered information on patients admitted for acute first-ever ischaemic stroke between January 2018 and January 2022. The following individuals were excluded from the study: 1) Those under 18 years of age; and 2) Pregnant women.

The variables gathered included the primary test parameters of patients within 24 hours of admission, encompassing age, gender, smoking and alcohol consumption status, arterial blood pressure, fat-related indicators, comorbidities, and the primary treatments administered within the initial 24 hours.

A national multicentre prospective cohort was utilized as the validation cohort for the previous prospective study, wherein comprehensive details regarding inclusion/exclusion criteria and study implementation have been previously documented (Annals of Neurology 2011, 70(2):265-273; Lipids in Health and Disease 2024, 23(1)). The primary institutions involved in this project include: five tertiary cardiovascular institutions in China: Fuwai Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College (Beijing); The First Affiliated Hospital of Xi'an Jiaotong University (Xi'an); Tongji Hospital, Huazhong University of Science and Technology (Wuhan); Tianjin Cardiovascular Institute (Tianjin); and Daping Hospital, Army Medical University (Chongqing). Data were collected from participants in a prospective cohort study carried out from November 2000 to November 2001 at five research centers in Wuhan, Xi'an, Beijing, Tianjin, and Chongqing in China.

This prospective cohort comprised 1268 patients experiencing their first-ever stroke, with a median follow-up duration of 5 years (range, 4-5.5 years). Individuals with concurrent chronic kidney disease or chronic respiratory ailments were excluded from the study. Blood samples were collected from these patient's post-acute stroke phase (within 1 month to 1 year after onset). Upon collection, the samples were promptly placed in pre-cooled centrifuge tubes and centrifuged under controlled temperatures to separate clear plasma from cellular precipitates. Subsequently, the samples were stored in an ultra-low temperature freezer at -80 degrees Celsius. The plasma KLK1 levels were quantified using a double antibody sandwich biotin affinity enzyme-linked immunosorbent assay kit. Secondary analyses were conducted using the clinical data, with detailed descriptions of the sample collection and assay protocols outlined in previous publications(Annals of Neurology 2011, 70(2):265-273; Lipids in Health and Disease 2024, 23(1)).

Being tested
No intervention
Keywords
stroke, Fat, Obesity, Metabolic syndrome
Medical subject headings
Ischemic Stroke, Stroke, Platelet Glycoprotein IV Deficiency, Obesity, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT06165107
Study groupRoleWhat they receive
Ischemic strokeWe retrospectively gathered information on patients admitted for acute first-ever ischaemic stroke between January 2018 and January 2022. The following individuals were excluded from the study: 1) Those under 18 years of age; and 2) Pregnant women. The variables gathered included the primary test parameters of patients within 24 hours of admission, encompassing age, gender, smoking and alcohol consumption status, arterial blood pressure, fat-related indicators, comorbidities, and the primary treatments administered within the initial 24 hours.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Death

    Measured: 10 years

  2. Mortality

    Death

    Measured: 5 years

  3. Recurrence

    Recurrent stroke

    Measured: 10 years

  4. Recurrence

    Recurrent stroke

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start1 Sep 2000
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

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
Retrospective
Enrolment
18,374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06165107
Sponsor's protocol ID
TJ-IRB20230830
Status last verified
May 2025
First submitted
3 Dec 2023
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Ischemic, run by Qin Zhang 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jun 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 10 years). The study lists 4 primary outcomes in all. 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 4 Jun 2025.

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