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

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ClinicalTrials.gov Identifier: NCT00314223
Recruitment Status : Unknown
Verified April 2006 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : April 13, 2006
Last Update Posted : April 13, 2006
Information provided by:
China Medical University Hospital

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
Sinus Arrhythmia

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : February 2006
Estimated Study Completion Date : December 2006

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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.

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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

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

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