NCT06165107

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18,374

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2000

Completed
21.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

21.4 years

First QC Date

December 3, 2023

Last Update Submit

May 29, 2025

Conditions

Stroke, Ischemic

Keywords

strokeFatObesityMetabolic syndrome

Outcome Measures

Primary Outcomes (4)

  • Mortality

    Death

    10 years

  • Mortality

    Death

    5 years

  • Recurrence

    Recurrent stroke

    10 years

  • Recurrence

    Recurrent stroke

    5 years

Study Arms (1)

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.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Ischemic stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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)).

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals under 18 years of age. Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Ischemic StrokeStrokePlatelet Glycoprotein IV DeficiencyObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Xiao Ran, phd

    ranxiao1001@tjh.tjmu.edu.cn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 3, 2023

First Posted

December 11, 2023

Study Start

September 1, 2000

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

June 4, 2025

Record last verified: 2025-05

Locations

CN(1)