Ischemic StrokeNCT01040182
Polymorphism of Estrogen Genes in Stroke
An observational study of Ischemic Stroke, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Nov 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 300 incident ischemic stroke patients will be recruited in the program project.
Who may be able to join
- incident ischemic stroke patients diagnosed by CT or MRI.
Who cannot join
- non ischemic stroke patients
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
WanFang Hospital
Taipei
Hung-Yi Chiou, Ph.D., 886-2-27361661 ext. 6512, hychiou@tmu.edu.tw
Chin-I Chen, M.D.
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke patients
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ischemic stroke patients | Not described | |
| healthy subjects without cerebrovascular disease | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hung-Yi Chiou, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040182
- Sponsor's protocol ID
- NSC 97-2321-B-038-002
- Status last verified
- Dec 2010
- First submitted
- 27 Dec 2009
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphism of Estrogen Genes in Stroke
- ClinicalTrials.gov ID
- NCT01040182
- Acronym / sponsor ID
- NSC 97-2321-B-038-002
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 29 Dec 2009 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ischemic stroke patients | – | – |
| healthy subjects without cerebrovascular disease | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 300 incident ischemic stroke patients will be recruited in the program project.
Key inclusion criteria (1 listed)
- incident ischemic stroke patients diagnosed by CT or MRI.
Key exclusion criteria (1 listed)
- non ischemic stroke patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
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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.
Hung-Yi Chiou principal investigator
Taipei Medical University WanFang 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 Ischemic Stroke, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 3 Dec 2010. 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 Taiwan. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 3 Dec 2010.