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Identification of Gene Polymorphism in Patients With Sick Sinus Syndrome in Chinese Population in Taiwan

Sponsor
China Medical University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00314223
Collaborator
(none)
300
Enrollment
1
Location
10
Duration (Months)
30.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Feb 1, 2006
    Study Completion Date :
    Dec 1, 2006

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      0 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      1. Heart rate was less than 40/min or long pause more than 3 seconds in series EKG or 24-hour EKG.

      2. Sinus nodal recovery time exceeds 1600 ms in cardiac electrophysiology study.

      Exclusion Criteria:

      1. Severe systemic disease.

      2. Acute coronary syndrome.

      3. Bradycardia with reversible cause.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 China Medical University Hospital Taichung Taiwan

      Sponsors and Collaborators

      • China Medical University Hospital

      Investigators

      • Principal Investigator: Jan-Yow Chen, MD, China Medical University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00314223
      Other Study ID Numbers:
      • DMR94-IRB-167
      First Posted:
      Apr 13, 2006
      Last Update Posted:
      Apr 13, 2006
      Last Verified:
      Apr 1, 2006
      Additional relevant MeSH terms:
      Arrhythmia, Sinus

      Study Results

      No Results Posted as of Apr 13, 2006