Clinical trial NCT05026489: G6PD Deficiency in Infarction Patients in Shaanxi Province
Official title: Prevalence of G6PD Deficiency in Cerebral Infarction Patients and the Correlation With Prognosis in Shaanxi Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Infarction
G6PD Deficiency
Keywords: Cerebral Infarction
G6PD Deficiency
Hemorrhagic transformation
Antiplatelet therapy
Antioxidant therapy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Simcere Company
First posted: 2021-08-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of G6PD deficiency
timeFrame: up to 24 weeks
Secondary outcomes:
measure: National Institute of Health stroke scale
timeFrame: 1 year
measure: All-cause mortality rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an Jiatong University
state: Shaanxi
Study officials:
affiliation: Xi'an Jiaotong University First Affiliated Hospital
name: Hongmei Cao, Professor
role: PRINCIPAL_INVESTIGATOR
References: