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

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT05410457
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

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.

Study Timeline

• Study Start: 2022-05-24
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-06-05
• Study First Posted: 2022-06-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2027-06-24
• Study Completion: 2027-06-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the changes of prognosis of stroke patients under different treatment strategies	3 months, 6 months, 12 months or 24 months	assessed by The Modified Rankin Score (mRS) of stroke patients \[mild to wores ranging from 0 to 5, 6 represents death\].
To assess the early neurological changes of ischemic stroke	7 days or 14 days	change from baseline National Institute of Health stroke scalescore (NIHSS) \[higher scores mean worse conditions\]7 days or 14 days

Secondary Outcome Measures

Name	Time	Method
To assess the incidence of recurrent stroke under different treatment strategies	7 days-24 months	record and analyze the incidence of recurrent stroke from 7 days-24 months
To assess the correlation of RNA/DNA and age factor in acute ischemic stroke	3 months	DNA and RNA extracted from peripheral blood samples
To assess the therapeutical effects of Edaravone dexborneol on inflammation and prognosis after acute ischemic stroke	3 months	The Modified Rankin Score score (mRS) of stroke patients \[mild to wores ranging from 0 to 5, 6 represents death\].
To assess the types and incidence of adverse events of ischemic stroke patients	3 days-24 months	adverse reactions (hemorrhage, embolus shedding, gastrointestinal ulcer) and stroke-related complications under different treatment strategies

Trial Locations

Locations (1)

Nanjing First Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China