GPS-IP: G6PD Deficiency in Infarction Patients in Shaanxi Province

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05026489

Collaborator

Simcere Company (Other)

1,000

Enrollment

Location

Anticipated Duration (Months)

38.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Infarction G6PD Deficiency	Genetic: G6PD gene deficiency

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prevalence of G6PD Deficiency in Cerebral Infarction Patients and the Correlation With Prognosis in Shaanxi Province

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
G6PD 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.	Genetic: G6PD gene deficiency we will use tetrazolazole-blue quantitative method to detect whether the patient suffer from G6PD deficiency.
Normal The G6PD activity ranged from 6.8 to 20.5 NBT and the G6PD activity is normal.

Arm

Intervention/Treatment

G6PD 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.

Genetic: G6PD gene deficiency

we will use tetrazolazole-blue quantitative method to detect whether the patient suffer from G6PD deficiency.

Normal

The G6PD activity ranged from 6.8 to 20.5 NBT and the G6PD activity is normal.

Outcome Measures

Primary Outcome Measures

Prevalence of G6PD deficiency [up to 24 weeks]
Prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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