G6PD Deficiency in Infarction Patients in Shaanxi Province

NCT ID: NCT05026489

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Cerebral Infarction G6PD Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

G6PD gene deficiency

Intervention Type GENETIC

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.

No interventions assigned to this group

Interventions

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G6PD gene deficiency

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

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Simcere Company

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongmei Cao, Professor

Role: PRINCIPAL_INVESTIGATOR

Xi'an Jiaotong University First Affiliated Hospital

Locations

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Xi'an Jiatong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongmei Cao, Professor

Role: CONTACT

008618991232710

Ying Tan, Doctor

Role: CONTACT

008617702961959

Facility Contacts

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Ying Tan

Role: primary

Other Identifiers

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XJTU1AF2021LSK-285

Identifier Type: -

Identifier Source: org_study_id

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