Sinus ArrhythmiaNCT00314223
Identification of Gene Polymorphism in Patients With Sick Sinus Syndrome in Chinese Population in Taiwan
An observational study of Sinus Arrhythmia, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Background: Sinus node dysfunction is a major cause of bradycardia necessitating pacemaker implantation. Evidences of genetic study supported that some genes involved in the pacemaker current or renin-angiotensin system were related to sinus node dysfunction. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinus Arrhythmia
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2006to Dec 2006
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Heart rate was less than 40/min or long pause more than 3 seconds in series EKG or 24-hour EKG.
- Sinus nodal recovery time exceeds 1600 ms in cardiac electrophysiology study.
Who cannot join
- Severe systemic disease.
- Acute coronary syndrome.
- Bradycardia with reversible cause.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Cheng-Chieh. Lin, MD, 886-4-22052121
About this study
Background: Sinus node dysfunction is a major cause of bradycardia necessitating pacemaker implantation. Evidences of genetic study supported that some genes involved in the pacemaker current or renin-angiotensin system were related to sinus node dysfunction. However, the influence of gene polymorphisms on sinus node dysfunction was not well studied.
Methods: A group of 100 patients with documented sinus node dysfunction and 100 age- and sex- matched healthy control patients will be enrolled into this study. Gene polymorphism study includes the angiotensin-I converting enzyme gene, angiotensin II type 1 receptor gene, HCN1-4, SCN5A, KCNE and other possible gene polymorphisms which are related to sinus node function based on previous reports. Genetic polymorphisms are identified with polymerase chain reaction-based restriction analysis. Comparison of multiple haplotype analysis and single-locus analysis will be analyzed between the cases and controls.
Read more
Estimated Results: Some genetic polymorphisms of these genes which are related to sinus node function or rennin-angiotensin system will show association with sinus node dysfunction. In multilocus haplotype analysis, some genetic haplotype profiles may demonstrate significant difference between cases and controls. In single locus analysis, some genetic polymorphisms may be associated with sinus node dysfunction.
Estimated Conclusion and Clinical Implication: This study will demonstrate the genetic polymorphisms in RAS genes or some other genes associated with sinus node dysfunction. These results will support the roles of these genetic polymorphisms in determining the risk of sinus node dysfunction among the Chinese population in Taiwan.
- Conditions
- Sinus Arrhythmia
- Medical subject headings
- Arrhythmia, Sinus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startFeb 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus ArrhythmiaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jan-Yow Chen, MD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314223
- Sponsor's protocol ID
- DMR94-IRB-167
- Status last verified
- Apr 2006
- First submitted
- 12 Apr 2006
- Last updated
- 13 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Gene Polymorphism in Patients With Sick Sinus Syndrome in Chinese Population in Taiwan
- ClinicalTrials.gov ID
- NCT00314223
- Acronym / sponsor ID
- DMR94-IRB-167
- Conditions
- Sinus Arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Dec 2006
- First posted
- 13 Apr 2006 (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.
Background: Sinus node dysfunction is a major cause of bradycardia necessitating pacemaker implantation. Evidences of genetic study supported that some genes involved in the pacemaker current or renin-angiotensin system were related to sinus node dysfunction. However, the influence of gene polymorphisms on sinus node dysfunction was not well studied.
Methods: A group of 100 patients with documented sinus node dysfunction and 100 age- and sex- matched healthy control patients will be enrolled into this study. Gene polymorphism study includes the angiotensin-I converting enzyme gene, angiotensin II type 1 receptor gene, HCN1-4, SCN5A, KCNE and other possible gene polymorphisms which are related to sinus node function based on previous reports. Genetic polymorphisms are identified with polymerase chain reaction-based restriction analysis. Comparison of multiple haplotype analysis and single-locus analysis will be analyzed between the cases and controls.
Estimated Results: Some genetic polymorphisms of these genes which are related to sinus node function or rennin-angiotensin system will show association with sinus node dysfunction. In multilocus haplotype analysis, some genetic haplotype profiles may demonstrate significant difference between cases and controls. In single locus analysis, some genetic polymorphisms may be associated with sinus node dysfunction.
Estimated Conclusion and Clinical Implication: This study will demonstrate the genetic polymorphisms in RAS genes or some other genes associated with sinus node dysfunction. These results will support the roles of these genetic polymorphisms in determining the risk of sinus node dysfunction among the Chinese population in Taiwan.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Heart rate was less than 40/min or long pause more than 3 seconds in series EKG or 24-hour EKG.
- Sinus nodal recovery time exceeds 1600 ms in cardiac electrophysiology study.
Key exclusion criteria (3 listed)
- Severe systemic disease.
- Acute coronary syndrome.
- Bradycardia with reversible cause.
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 13 Apr 2006.
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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.
Jan-Yow Chen, MD principal investigator
China Medical University 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 Sinus Arrhythmia, run by China Medical University 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 2 inclusion and 3 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 13 Apr 2006. 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?
Contact Jan-Yow Chen, MD (886-4-22052121, janyow@ms77.hinet.net), or a site near the patient. 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 13 Apr 2006.