Cerebral InfarctionGPS-IPNCT05026489
G6PD Deficiency in Infarction Patients in Shaanxi Province
An observational study of Cerebral Infarction and G6PD Deficiency, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Infarction, G6PD Deficiency
- What is being tested?
- G6PD gene deficiency
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xi'an Jiatong University
Xi'an, Shaanxi
Ying Tan, 1988-tanying@163.com
About this study
Official title: 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.
- Conditions
- Cerebral Infarction, G6PD Deficiency
- Being tested
- G6PD gene deficiency
- Keywords
- Cerebral Infarction, G6PD Deficiency, Hemorrhagic transformation, Antiplatelet therapy, Antioxidant therapy
- Medical subject headings
- Cerebral Infarction, Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G6PD gene deficiencyGenetic
we will use tetrazolazole-blue quantitative method to detect whether the patient suffer from G6PD deficiency.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: G6PD gene deficiency | |
| Normal | The G6PD activity ranged from 6.8 to 20.5 NBT and the G6PD activity is normal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of G6PD deficiency
Prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province
Measured: up to 24 weeks
Secondary outcomes (2)
National Institute of Health stroke scale
on a scale of 0-42, the higher the score, the more damage of the nervous system
Measured: 1 year
All-cause mortality rate
All-cause mortality was calculated in % for both groups
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Simcere Company
- Responsible party
- Sponsor
- Investigators
- Hongmei Cao, Professor, Principal investigator, Xi'an Jiaotong University First Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026489
- Sponsor's protocol ID
- XJTU1AF2021LSK-285
- Acronym
- GPS-IP
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of G6PD Deficiency in Cerebral Infarction Patients and the Correlation With Prognosis in Shaanxi Province
- ClinicalTrials.gov ID
- NCT05026489
- Acronym / sponsor ID
- GPS-IP / XJTU1AF2021LSK-285
- Conditions
- Cerebral Infarction, G6PD Deficiency
- Keywords
- Cerebral Infarction, G6PD Deficiency, Hemorrhagic transformation, Antiplatelet therapy, Antioxidant therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Simcere Company
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G6PD Deficiency | – | Genetic: G6PD gene deficiencyIn 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. |
| Normal | – | –The G6PD activity ranged from 6.8 to 20.5 NBT and the G6PD activity is normal. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G6PD gene deficiencywe will use tetrazolazole-blue quantitative method to detect whether the patient suffer from G6PD deficiency. | Genetic | G6PD Deficiency |
Primary outcome
Prevalence of G6PD deficiency
Time frame: up to 24 weeks
Prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province
2 secondary outcomes
National Institute of Health stroke scale
Time frame: 1 year
All-cause mortality rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongmei Cao, Professor principal investigator
Xi'an Jiaotong University First Affiliated Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Infarction and G6PD Deficiency, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongmei Cao, Professor (008618991232710, chm1027@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of G6PD deficiency (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.