G6PD Deficiency in Infarction Patients in Shaanxi Province

Cerebral Infarction Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026489
• Other study ID #: XJTU1AF2021LSK-285
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Hongmei Cao, Professor
• Phone: 008618991232710
• Email: chm1027[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• G6PD Deficiency
• Glucosephosphate Dehydrogenase Deficiency
• Infarction

Intervention

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

Locations

Country	Name	City	State
China	Xi'an Jiatong University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Simcere Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of G6PD deficiency	Prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province	up to 24 weeks
Secondary	National Institute of Health stroke scale	on a scale of 0-42, the higher the score, the more damage of the nervous system	1 year
Secondary	All-cause mortality rate	All-cause mortality was calculated in % for both groups	1 year