Are certain forms of the P2Y2 gene associated with the risk of stroke in northern Han Chinese people?
| ISRCTN | ISRCTN11439124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11439124 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 15/10/2018
- Registration date
- 24/10/2018
- Last edited
- 13/12/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
People in northern China are at an increased risk of ischemic stroke (damage to the brain caused by narrowing of blood vessels in the brain). This study aimed to investigate if gene forms linked to increased risk of stroke are more common in Han Chinese people in this region.
Who can participate?
People aged 45-80 years who had had an ischemic stroke and healthy volunteers matched in terms of age, gender, ethnic group and area of residence with the stroke group.
What does the study involve?
One sample of blood was taken from a vein (usually in the arm).
What are the possible benefits and risks of participating?
There was the potential for discomfort when the blood was taken. There are no potential benefits of taking part.
Where is the study run from?
The First Affiliated Hospital of China Medical University.
When is the study starting and how long is it expected to run for?
The samples were collected from September 2010 to May 2011 and the data analysed from March 2012 to April 2012.
Who is funding the study?
This study was supported by a grant from the National Natural Science Foundation of China, No. 81070913.
Who is the main contact?
Zhi-yi He
Hezhiyi0301@sina.com
Contact information
Public
No.155, Nanjing North Street, Heping District
Shenyang
110000
China
| Phone | 13998250891 |
|---|---|
| cmu_jane@sina.com |
Study information
| Study design | Observational case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| Scientific title | G-Protein Coupled Purinergic Receptor P2Y2 (P2RY2) gene rs4944832 polymorphism increases the risk of ischemic stroke in the northern Han Chinese population |
| Study objectives | The G-C-G haplotype of P2RY2 is a susceptibility haplotype for ischemic stroke. In addition, the GG genotype of rs4944832 may be associated with the development of small-artery occlusion in the northern Han Chinese population. |
| Ethics approval(s) | 1. Ethics Committee of the First Affiliated Hospital of China Medical University, 20/02/2012, 2012-38-1 2. Ethics Committee of the First Affiliated Hospital of Liaoning Medical University, 01/03/2013, 2013-03-1 |
| Health condition(s) or problem(s) studied | Ischemic stroke |
| Intervention | In this study, clinical data and peripheral blood specimens were collected from ischemic stroke patients and controls. The ischemic stroke participants were recruited from the First Affiliated Hospital of China Medical University and the First Affiliated Hospital of Liaoning Medical University. The controls were recruited from the Health Check Center at the First Affiliated Hospital of China Medical University. Ischemic stroke patients were divided into two subgroups according to the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) classification: large-artery atherosclerosis (n = 178) and small-artery occlusion (n = 200) strokes. All subjects were genotyped using SNaPshot® Multiplex (Thermo Fisher Scientific) for three single-nucleotide polymorphisms in the P2RY2 gene (rs4944831, rs1783596 and rs4944832) in peripheral venous blood. |
| Intervention type | Genetic |
| Primary outcome measure | The genotype frequencies of the three P2RY2 SNPs (rs4944831, rs1783596, and rs4944832) in ischemic stroke patients and controls. |
| Secondary outcome measures | 1. Allele frequencies of the three P2RY2 SNPs (rs4944831, rs1783596, and rs4944832) in ischemic stroke patients and controls. 2. Inferred haplotypes of these three P2RY2 SNPs (rs4944831, rs1783596, and rs4944832). |
| Overall study start date | 01/05/2010 |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 722 |
| Key inclusion criteria | Inclusion criteria for the ischemic stroke group: 1. According to the TOAST classification, patients in the ischemic stroke group were diagnosed depending on clinical features and neuroimaging criteria that included the sudden onset of a global or focal neurological deficit, with corresponding brain infarction as seen on computed tomography (CT) imaging or magnetic resonance imaging (MRI) (Adams et al., 1993). Examinations of cerebral blood vessels, such as computed tomography angiography and magnetic resonance angiography, were performed when necessary. Inclusion criteria for the control group: 1. Unrelated healthy controls with no clinical or radiological evidence of stroke or cerebrovascular diseases. 2. Some healthy controls had vascular risk factors such as hypertension, diabetes, smoking, drinking, and hypercholesterolemia. |
| Key exclusion criteria | Exclusion criteria for the ischemic stroke group: 1. Cancer 2. Hemorrhagic stroke 3. Transient ischemic attack 4. Severe cardiac, hepatic, or renal diseases Exclusion criteria for control subjects: 1. Cancer 2. Autoimmune disease 3. Chronic inflammation 4. Renal insufficiency 5. Liver insufficiency 6. Hematopathy |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 30/05/2011 |
Locations
Countries of recruitment
- China
Study participating centres
Shenyang
110000
China
Jinzhou
121000
China
Sponsor information
Hospital/treatment centre
No.155, Nanjing North Street, Heping District
Shenyang
110000
China
| Phone | 86-024-961200 |
|---|---|
| ydyyyzxx@126.com | |
"ROR" |
https://ror.org/04wjghj95 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 17/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2019 | Yes | No |
Editorial Notes
DK 13/12/2018: Publication reference added.
