G6PD Deficiency in Infarction Patients in Shaanxi Province

• Conditions: Cerebral Infarction; G6PD Deficiency
• Interventions: Genetic: G6PD gene deficiency

• Registration Number: NCT05026489
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

Cerebral infarction brings heavy burden to patients and families with high morbidity, mortality, disability and recurrence rate. Anti-platelet aggregation therapy plays important role for secondary prevention of cerebral infarction. G6PD deficiency is a rare genetic disorder, patients with this disorder could suffer hemolysis after eating broad beans. Professor Zeng Jinsheng et al found that the hemolysis risk of G6PD deficiency patients was significantly increased when aspirin was applied in Guangdong Province. However, the prevalence of G6PD deficiency in northern China remains unknown, as well as the safety of antiplatelet therapy. To this end, 1000 patients with acute cerebral infarction will be continuously included in 30 second-level and above hospitals in 10 prefectures and cities of Shaanxi Province for observation and follow-up for 12 months, to explore the prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province, and to analyze the relationship between G6PD deficiency and the clinical characteristics and prognosis of cerebral infarction. To clarify the efficacy and safety of antiplatelet therapy for G6PD patients with cerebral infarction is of great significance for guiding the individualized treatment of cerebral infarction.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-27
• Study First Posted: 2021-08-30
• Study Start: 2021-11-01
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• meets the diagnostic criteria of acute cerebral infarction established by Neurology Society of Chinese Medical Association, and confirmed by cranial Magnetic Resonance Imaging；
• Time from onset to enrollment ≤14 days;
• Volunteer to participate in the study and sign the informed consent.

Exclusion Criteria

• Silent cerebral infarction with no symptoms and signs;
• Complicated with post-infarction hemorrhage;
• Cerebral hernia and other complications caused by massive cerebral infarction may lead to death in acute phase;
• Cardiogenic cerebral embolism caused by atrial fibrillation;
• Cerebral infarction caused by tumor, vasculitis and other special reasons;
• Complicated with serious systemic diseases, including liver and kidney insufficiency, respiratory failure, heart failure, infection, etc

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
G6PD Deficiency	G6PD gene deficiency	In the laboratory of the First Affiliated Hospital of Xi 'an Jiaotong University, tetrazolazole-blue quantitative method will be used to detect G6PD. According to the normal range of the tetrazole-blue quantitative method (6.8-20.5NBT), adults with G6PD activity \< 6.8NBT were positive, and G6PD deficiency is confirmed.

Primary Outcome Measures

Name	Time	Method
Prevalence of G6PD deficiency	up to 24 weeks	Prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province

Secondary Outcome Measures

Name	Time	Method
National Institute of Health stroke scale	1 year	on a scale of 0-42, the higher the score, the more damage of the nervous system
All-cause mortality rate	1 year	All-cause mortality was calculated in % for both groups

Trial Locations

Locations (1)

Xi'an Jiatong University; 🇨🇳 Xi'an, Shaanxi, China