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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | September 12, 2005 | ||||||||
| Start Date ICMJE | June 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Congenital or Idiopathic Complete Right Bundle Branch Block: Physiological Significance and Molecular Characterization | ||||||||
| Official Title ICMJE | Congenital or Idiopathic Complete Right Bundle Branch Block: Physiological Significance and Molecular Characterization | ||||||||
| Brief Summary | This study is to determine 1) the incidence of altered right bundle conduction, including CRBBB, IRBBB or rsR’ pattern in the Taipei city based on the school survey databank from 1999 to 2002, 2) the associated cardiac lesions, 3) clinical presentations relevant to the altered right bundle conduction, 4) the association with QTc prolongation and dispersion and HRV from a 5-minutes recording. Finally, molecular characterization for those with CRBBB or Brugada pattern EKG, especially those with positive family history will be studied. |
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| Detailed Description | The EKG pattern and medical records from the school survey from 1999 to 2002 in Taipei city will be reviewed, and the basic data of those with CRBBB, IRBBB and rsR’ pattern will be recorded. Interview will be made and the echocardiographic measurements will be performed to identify associated cardiac defects. EKG parameters and QT, QTc, QT dispersion, QTc dispersion and HRV parameters will be obtained from a semi-automated system. Time domain and frequency domain measures will be calculated and expressed as SDNN, triangular index, SDNN index, total power, low frequency power and high frequency power. Mutational analysis and DNA sequencing will be conducted in those with CRBBB or Brugada pattern EKG, especially those with positive family history. Based on these data, the clinical significance of altered bundle branch conduction identified from a school survey may be defined. For those with isolated CRBBB or IRBBB, the adjunctive value of HRV and QT parameters will determined the high risk group, and 24 hour Holter recording and Treadmill exercise test will then perform in these patients to define association with ventricular arrhythmia. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Screening, Cross-Sectional, Defined Population, Prospective Study | ||||||||
| Condition ICMJE | Bundle-Branch Block | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 8 Years to 25 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00173342 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 9461700620 | ||||||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||||||
| Verification Date | June 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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