Bundle-Branch BlockNCT00173342
Congenital or Idiopathic Complete Right Bundle Branch Block: Physiological Significance and Molecular Characterization
An observational study of Bundle-Branch Block, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Bundle-Branch Block
- How many people
- 50 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jun 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ECG showed right bundle branch block
Who cannot join
- can't tolerate Treadmill ECG study
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Department of Pediatrics, National Taiwan University Hospital
Taipei, 100
Mei-Hwan Wu, MD, PhD, 886-2-23123456 ext. 5126, mhwu@ha.mc.ntu.edu.tw
Shuenn-Nan Chiu, MD, 886-2-23123456 ext. 5126, michael@ha.mc.ntu.edu.tw
- Recruiting
Pediatric Department, National Taiwan University Hospital
Taipei, 100
Shuenn-Nan Chiu, MD, 886-2-23123456 ext. 5126, michael@ha.mc.ntu.edu.tw
Mei-Hwan Wu, MD, PhD, 886-2-23123456 ext. 5126, mhwu@ha.mc.ntu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Bundle-Branch Block
- Keywords
- Right bundle branch block, Electrocardiography, Ion channel
- Medical subject headings
- Bundle-Branch Block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bundle-Branch BlockStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Mei-Hwan Wu, MD, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173342
- Sponsor's protocol ID
- 9461700620
- Status last verified
- Jun 2005
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital or Idiopathic Complete Right Bundle Branch Block: Physiological Significance and Molecular Characterization
- ClinicalTrials.gov ID
- NCT00173342
- Acronym / sponsor ID
- 9461700620
- Conditions
- Bundle-Branch Block
- Keywords
- Right bundle branch block, Electrocardiography, Ion channel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ECG showed right bundle branch block
Key exclusion criteria (1 listed)
- can't tolerate Treadmill ECG study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Hwan Wu, MD, PhD study chair
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bundle-Branch Block, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Hwan Wu, MD, PhD (886-2-23123456 ext. 5126, mhwu@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2005.