Sick Sinus SyndromeNCT01310920
The Role of Angiotensinogen Gene Polymorphism in the Pathogenesis of Non-familial Sick Sinus Syndrome
An observational study of Sick Sinus Syndrome, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Evidence has been documented for the close relationship between the arrhythmia pathogenesis and the gene expression in renin-angiotensin system. However, it remains unclear for involvement of RAS in the pathogenesis of non-familial sick sinus syndrome. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sick Sinus Syndrome
- What is being tested?
- observation
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to not given
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The case group includes 200 patients and the control group includes 200 patients.
Who may be able to join
- sick sinus syndrome
Who cannot join
- 1.Severe systemic disease.
- 2.Acute coronary syndrome.
- 3.bradycardia with reversible cause.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Dawan, Taiwan, 404
Jan-Yow Chen, M.D., +886-4-22062121 ext. 2311, janyow@ms77.hinet.net
Jan-Yow Chen, MD
About this study
Evidence has been documented for the close relationship between the arrhythmia pathogenesis and the gene expression in renin-angiotensin system. However, it remains unclear for involvement of RAS in the pathogenesis of non-familial sick sinus syndrome. The researchers thus investigated the possible relationship between non-familial sick sinus syndrome and the polymorphism and haplotype of the AGT promoter.
- Conditions
- Sick Sinus Syndrome
- Being tested
- observation
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
genotyping
| Study group | Role | What they receive |
|---|---|---|
| sick sinus syndrome | Not described Receives: Other: observation | |
| control | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sick Sinus SyndromeStudies 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
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jan-Yow Chen, M.D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310920
- Sponsor's protocol ID
- DMR99-IRB-316
- Status last verified
- Mar 2011
- First submitted
- 6 Mar 2011
- Last updated
- 9 Mar 2011
- Results posted
- No
Publications
Mangrum JM, DiMarco JP. The evaluation and management of bradycardia. N Engl J Med. 2000 Mar 9;342(10):703-9. doi: 10.1056/NEJM200003093421006. No abstract available.
PubMed 10706901
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Angiotensinogen Gene Polymorphism in the Pathogenesis of Non-familial Sick Sinus Syndrome
- ClinicalTrials.gov ID
- NCT01310920
- Acronym / sponsor ID
- DMR99-IRB-316
- Conditions
- Sick Sinus Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- First posted
- 9 Mar 2011 (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.
Evidence has been documented for the close relationship between the arrhythmia pathogenesis and the gene expression in renin-angiotensin system. However, it remains unclear for involvement of RAS in the pathogenesis of non-familial sick sinus syndrome. The researchers thus investigated the possible relationship between non-familial sick sinus syndrome and the polymorphism and haplotype of the AGT promoter.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sick sinus syndrome | – | Other: observation |
| control | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The case group includes 200 patients and the control group includes 200 patients.
Key inclusion criteria (1 listed)
- sick sinus syndrome
Key exclusion criteria (3 listed)
- 1.Severe systemic disease.
- 2.Acute coronary syndrome.
- 3.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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationgenotyping | Other | sick sinus syndrome |
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 9 Mar 2011.
- Background: PubMed 10706901Mangrum JM, DiMarco JP. The evaluation and management of bradycardia. N Engl J Med. 2000 Mar 9;342(10):703-9. doi: 10.1056/NEJM200003093421006. No abstract available.
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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, M.D. 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 Sick Sinus Syndrome, 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 1 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 9 Mar 2011. 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 (+886-4-22062121 ext. 2311, 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?
On the ClinicalTrials.gov record for NCT01310920, which also lists 1 linked publication.
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 9 Mar 2011.