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.
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
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)).
- Conditions
- Stroke, Ischemic
- 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 group | Role | What they receive |
|---|---|---|
| Ischemic stroke | 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death
Measured: 10 years
Mortality
Death
Measured: 5 years
Recurrence
Recurrent stroke
Measured: 10 years
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.
- First posted11 Dec 2023
- Study start1 Sep 2000
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 18,374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Zhang, Tongji Hospital
- Investigators
- Xiao Ran, phd, Principal investigator, ranxiao1001@tjh.tjmu.edu.cn
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Stroke: Exploring the Clinical Connection Through Epidemiology and Molecular Medicine
- ClinicalTrials.gov ID
- NCT06165107
- Acronym / sponsor ID
- TJ-IRB20230830
- Conditions
- Stroke, Ischemic
- Keywords
- stroke, Fat, Obesity, Metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,374 participants (actual)
- Lead sponsor
- Qin ZhangUniversity, hospital or other
- Study start
- 1 Sep 2000 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 11 Dec 2023 (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.
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).
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)).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke | – | Other: No interventionWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals under 18 years of age. Pregnant women.
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 |
|---|---|---|
| No interventionNo intervention | Other | Ischemic stroke |
Primary outcome
Mortality
Time frame: 10 years
Death
Mortality
Time frame: 5 years
Death
Recurrence
Time frame: 10 years
Recurrent stroke
Recurrence
Time frame: 5 years
Recurrent stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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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.
Xiao Ran, phd principal investigator
ranxiao1001@tjh.tjmu.edu.cn
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 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; AzTrials last refreshed its copy on 7 Nov 2026.