G6PD Deficiency in Infarction Patients in Shaanxi Province

NCT05026489 | Unknown

• 1 other identifier: XJTU1AF2021LSK-285
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Infarction; G6PD Deficiency

Keywords

Cerebral Infarction; G6PD Deficiency; Hemorrhagic transformation; Antiplatelet therapy; Antioxidant therapy

Outcome Measures

Primary Outcomes (1)

• Prevalence of G6PD deficiency

  Prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province

  up to 24 weeks

Secondary Outcomes (2)

• National Institute of Health stroke scale

  1 year

• All-cause mortality rate

  1 year

Study Arms (2)

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

Normal

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

Interventions

G6PD gene deficiency GENETIC

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

G6PD Deficiency

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with acute cerebral infarction hospitalized in 30 secondary hospitals in Shaanxi province, including the First Affiliated Hospital of Xi 'an Jiaotong University.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Simcere Company: collaborator

Study Sites (1)

Xi'an Jiatong University

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Cerebral Infarction; Glucosephosphate Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hongmei Cao, Professor

  Xi'an Jiaotong University First Affiliated Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongmei Cao, Professor

CONTACT

008618991232710; chm1027@163.com

Ying Tan, Doctor

CONTACT

008617702961959; 1988-tanying@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 30, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 29, 2022

Record last verified: 2021-08

Locations

CN (1)