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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2006 by China Medical University Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: April 13, 2006
Last Update Posted: April 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
China Medical University Hospital

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.

Sinus Arrhythmia

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by China Medical University Hospital:

Estimated Enrollment: 300
Study Start Date: February 2006
Estimated Study Completion Date: December 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314223

Contact: Jan-Yow Chen, MD 886-4-22052121 janyow@ms77.hinet.net

China Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Cheng-Chieh. Lin, MD    886-4-22052121      
Sponsors and Collaborators
China Medical University Hospital
Principal Investigator: Jan-Yow Chen, MD China Medical University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00314223     History of Changes
Other Study ID Numbers: DMR94-IRB-167
First Submitted: April 12, 2006
First Posted: April 13, 2006
Last Update Posted: April 13, 2006
Last Verified: April 2006

Additional relevant MeSH terms:
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes