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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410457
• Other study ID #: AISDTS
• Status: Recruiting
• Start date: May 24, 2022
• Est. completion date: June 24, 2027

Study information

• Verified date: June 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Qiwen Deng, M.D.
• Phone: +86025-87726218
• Email: qiw_deng[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 24, 2027
• Est. primary completion date: June 24, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	3 months, 6 months, 12 months or 24 months
Primary	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	7 days or 14 days
Secondary	To assess the incidence of recurrent stroke under different treatment strategies	record and analyze the incidence of recurrent stroke from 7 days-24 months	7 days-24 months
Secondary	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	3 days-24 months
Secondary	To assess the correlation of RNA/DNA and age factor in acute ischemic stroke	DNA and RNA extracted from peripheral blood samples	3 months
Secondary	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].	3 months