G6PD Deficiency in Infarction Patients in Shaanxi Province (GPS-IP)

April 28, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hongmei Cao, Professor
  • Phone Number: 008618991232710
  • Email: chm1027@163.com

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of G6PD deficiency
Time Frame: up to 24 weeks
Prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institute of Health stroke scale
Time Frame: 1 year
on a scale of 0-42, the higher the score, the more damage of the nervous system
1 year
All-cause mortality rate
Time Frame: 1 year
All-cause mortality was calculated in % for both groups
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Simcere Company

Investigators

  • Principal Investigator: Hongmei Cao, Professor, Xi'an Jiaotong University First Affiliated Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2021LSK-285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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