A Research of Application of the New Model of Standardized Secondary Prevention of Stroke

NCT05757635 | Unknown

• 1 other identifier: Archimedes
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

To promote the application of the standardized secondary prevention of stroke in primary hospitals,and further reduce the recurrence rate, disability rate, and socioeconomic burden in China, the investigators aim to popularize the standard secondary stroke prevention strategy through artificial intelligence technology, and thus to establish an information management system for standard treatment of stroke.

Conditions

Acute Ischemic Stroke

Keywords

ischemic stroke; standard secondary prevention; artificial intelligence technology

Outcome Measures

Primary Outcomes (1)

• The recurrence rate of acute ischemic stroke

  The recurrence rate of acute ischemic stroke

  3 months

Secondary Outcomes (8)

• The improvement of National Institutes of Health Stroke Scale（NIHSS） score

  3 months

• The improvement of Modified Rankin Scale（mRS）score

  3 months，6 months ，12 months

• The improvement of Barthel index score

  3 months，6 months ，12 months

• The ratio of good prognosis

  3 months，12 months

• The recurrence rate of acute ischemic stroke

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke

You may qualify if:

• First clinical onset or previous cerebral infarction without serious sequela (mRS is 0-2 points)
• Age ≥ 18 years old
• Patients or family members own and use smart phones
• Informed consent signed by the patient or his/her legal representative

You may not qualify if:

• Cranial CT confirmed intracranial hemorrhagic diseases (cerebral hemorrhage, subarachnoid hemorrhage) or malignant space occupying lesions
• Transient ischemic attack, or stroke mimic
• Cerebral embolism or suspected cerebral embolism, or other clear anticoagulant indications (such as DVT)
• Severe disturbance of consciousness: GCS≤8
• Dysphagia; or gastrointestinal disease or gastrointestinal surgery may affect gastrointestinal absorption
• After the onset of thrombolysis, stent surgery, or will carry out arteriovenous thrombolysis, interventional or stent surgery patients
• Angioplasty or other operations that need to suspend antiplatelet drugs may be performed in the last 3 months
• Patients with severe heart, lung and kidney dysfunction (creatinine \> 2.0 mg/dL or 177 /μ mol/L), severe liver damage (alanine aminotransferase/aspartate transaminas，ALT/AST\>1.5×ULN), malignant tumor, etc., with life expectancy less than 3 months
• Patients with hemorrhagic tendency, laboratory examination: international normalized ratio （INR）\> 1.5 or activated partial thromboplastin time（APTT） \> 2 times or platelet （PLT ）\< 100×10\^9 / L
• Patients with previous allergy or intolerance to clopidogrel and aspirin
• Pregnant or lactating women
• Patients who could not be followed up as required during the study period
• Without pariticipation in other intervention clinical studies in the last three months

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• CSPC-NBP Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 7, 2023
• Study Start: March 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 7, 2023

Record last verified: 2022-12