Polymorphism of Estrogen Genes in Stroke
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | December 27, 2009 | ||||
| Last Updated Date | December 1, 2010 | ||||
| Start Date ICMJE | December 2009 | ||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01040182 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Polymorphism of Estrogen Genes in Stroke | ||||
| Official Title ICMJE | Polymorphism of Estrogen Genes in Stroke | ||||
| Brief Summary | The purpose of this study is to explore the association between the genetic polymorphisms of estrogen-related genes, including estrogen synthesis, metabolizing, and receptor genes, and ischemic stroke. Furthermore, independent and joint effects of traditional risk factors and estrogen related genes on risk of stroke in young adults will also be examined in this study. |
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| Detailed Description | Cerebrovascular diseases are the third leading cause of death in Taiwan in 2007. It is also the most important reason for disability among elderly adults. Sex hormones are well reported to be associated with cardiovascular disease risk. Several studies showed that estrogens have been shown to have beneficial effects on the cardiovascular system via favorable effects on anti-inflammatory effects. Genetic polymorphisms of estrogen related genes are speculated to influence estrogen level and will count for human susceptible to risk of stroke in young adults. In addition, several studies showed that the decrease in estrogen-induced vascular inflammatory markers including adhesion molecules and chemokines might be the mechanism for vascular protection. Recently, a novel and unique mechanisms for 17β-Estradiol (E2) anti-inflammatory activity which is E2 prevents inflammatory gene transcription induced by inflammatory agents by inhibiting NF-κB intracellular transport was found. Therefore, we proposed a study to explore the association between the genetic polymorphisms of estrogen-related genes, including estrogen synthesis, metabolizing, receptor genes, and NF-κB and ischemic stroke in young adults. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Buffy coat and plasma will be retained. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | A total of 300 incident ischemic stroke patients will be recruited in the program project. |
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| Condition ICMJE | Ischemic Stroke | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | November 2010 | ||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01040182 | ||||
| Other Study ID Numbers ICMJE | NSC 97-2321-B-038-002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hung-Yi Chiou, Ph.D./PI, National Science Council | ||||
| Study Sponsor ICMJE | Taipei Medical University WanFang Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Taipei Medical University WanFang Hospital | ||||
| Verification Date | December 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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