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RecruitingNCT05410457Updated Apr 9, 2026

Different Treatment Strategies on Prognosis of Acute Ischemic Stroke(AISDTS)

An observational study in Ischemic Stroke, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study summary

AISDTS is a prospective registry study, in which clinical information, examination and imaging data of patients with acute ischemic stroke receiving different treatment strategies were collected, grouped and statistically analyzed, and corresponding clinical prediction models were constructed to explore the role of clinical biological indicators in the occurrence and development of stroke.

Read the detailed description
  1. To study which variable or variables (various clinical biological indicators) affect the prognosis of ischemic stroke patients;
  2. To study the differences in variables (various clinical evaluations, biological indicators, etc.) among patients receiving different treatment strategies (including thrombolysis group, thrombectomy group, stent group, chronic occlusion reperfusion group and regular treatment group);
  3. To study hemoglobin, mean erythrocyte volume, white blood cell count, neutrophil count, lymphocyte count, monocyte count, IL-2, IL-4, IL-6, IL-10, IFNγ, TNFα, C-reactive protein, serum iron and iron-related proteins (ferritin, transferrin, fibromodulin, ceruloplasmin), uric acid, amino acid, lipoprotein, homocysteine, vitamin D and other clinical indicators that correlated with acute ischemic stroke patients and different treatment groups were compared;
  4. To study the relationship between blood pressure changes at multiple time points from admission to discharge and clinical manifestations and prognosis of stroke patients, and to make comparison between groups;
  5. To study the relationship between ischemic stroke and other variables (clinical assessment, biological, genetic and neuroimaging) in different pathological types;
  6. To study the correlation between neuroimaging indicators and clinical evaluation, biomolecular, genetic and other variables;
  7. DNA and RNA were extracted from peripheral blood samples of patients with acute stroke for genetic related studies to explore the genetic susceptibility of young stroke and unexplained stroke;
  8. To study the role of one-stop multimodal-MRI in the assessment and diagnosis of patients with acute ischemic stroke;
  9. To study the adverse reactions (hemorrhage, embolus shedding, gastrointestinal ulcer) and stroke-related complications under different treatment strategies (including thrombolysis group, thrombectomy group, stent group, chronic occlusion reperfusion group and regular treatment group);
  10. To study the effect of Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) on inflammation and the prognosis in ischemic stroke patients.
02

Conditions studied

  • Ischemic Stroke

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Keywords

  • ischemic stroke
  • clincial indicators
  • thrombolysis
  • thrombectomy
  • neuroimaging
  • genetics
  • one-stop multimodal-MRI
  • stroke related complications
03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 300 across 777 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients admitted to hospital for ischemic stroke were enrolled.

Inclusion criteria

  • A) ≥18 years of age; B) hospital admission for ischemic stroke; C) Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  • A) patients with incomplete clinical information; B) hospitalization observation time less than 24 hours; C) recent trauma, severe inflammation, severe liver and kidney dysfunction, progressive malignance and other serious diseases; D) baseline mRS score>2; E) informed consent is not signed.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • thrombolysis group

    Inclusion criteria: a) age ≥18 years; B) hospital admission for acute ischemic stroke; C) the time from onset to admission ≤ 4.5 hours; D) received intravenous thrombolysis; E) signed informed consent.

  • thrombectomy group

    Inclusion criteria: a) age ≥18 years; B) hospital admission for acute ischemic stroke; C) the time from onset to admission ≤ 24 hours; D) vascular assessment by CTA or multimodal MRI; E) received thrombectomy; F) signed informed consent.

  • stent group

    Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) vascular assessment by CTA or multimodal MRI; D) received stent implantation ; E) Signed informed consent.

  • regular treatment group

    Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) received regular medical treatment; D) signed informed consent.

  • young stroke group

    Inclusion criteria: a) age between 18 and 50 years of age (45/55Y); B) hospital admission due to ischemic stroke; C) received CT or MRI imaging assessment; D) signed informed consent.

  • unexplained stroke group

    Inclusion criteria: a) age ≥18 years; B) hospital admission due to ischemic stroke; C) Received CT or MRI imaging assessment; D)TOAST was classified as unknown cause type (including two or more causes and no cause was found by auxiliary examination); E) signed informed consent.

06

What researchers measure

Primary outcomes

  1. To assess the changes of prognosis of stroke patients under different treatment strategies

    assessed by The Modified Rankin Score (mRS) of stroke patients \[mild to wores ranging from 0 to 5, 6 represents death\].

    Time frame: 3 months, 6 months, 12 months or 24 months

  2. To assess the early neurological changes of ischemic stroke

    change from baseline National Institute of Health stroke scalescore (NIHSS) \[higher scores mean worse conditions\]7 days or 14 days

    Time frame: 7 days or 14 days

Secondary outcomes

  1. To assess the incidence of recurrent stroke under different treatment strategies

    record and analyze the incidence of recurrent stroke from 7 days-24 months

    Time frame: 7 days-24 months

  2. To assess the types and incidence of adverse events of ischemic stroke patients

    adverse reactions (hemorrhage, embolus shedding, gastrointestinal ulcer) and stroke-related complications under different treatment strategies

    Time frame: 3 days-24 months

  3. To assess the correlation of RNA/DNA and age factor in acute ischemic stroke

    DNA and RNA extracted from peripheral blood samples

    Time frame: 3 months

  4. To assess the therapeutical effects of Edaravone dexborneol on inflammation and prognosis after acute ischemic stroke

    The Modified Rankin Score score (mRS) of stroke patients \[mild to wores ranging from 0 to 5, 6 represents death\].

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Nanjing First Hospital, Nanjing Medical University
    Nanjing, Jiangsu 210006, China
    Recruiting
08

References and documents

Publications

  • Li Z, Sun C, Zhang Q, Ji L, Zhang Y, Li S, Gu M, Gao J, Huang Z, Wang M, Zhou J, Zhu L, Jiang T, Zhou Q, Deng Q. Impact of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor on Immune-Inflammatory Responses in the Acute Phase of Ischemic Stroke. J Inflamm Res. 2026 Apr 30;19:590179. doi: 10.2147/JIR.S590179. eCollection 2026. PubMed 42089099 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05410457
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Sponsor
First posted
Jun 8, 2022
Start date
May 24, 2022
Primary completion
Jun 24, 2027 (estimated)
Completion
Jun 24, 2027 (estimated)
Last update
Apr 9, 2026

Study contacts

Qiwen Deng, M.D.
Contact
qiw_deng@163.com
+86025-87726218

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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