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

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. 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

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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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 identifier (NCT number): NCT00314223

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Contact: Jan-Yow Chen, MD 886-4-22052121

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

Layout table for additonal information Identifier: NCT00314223    
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:
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Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes