Long QT SyndromeNCT00488254
The Long QT Syndrome in Pregnancy
An observational study of Long QT Syndrome, run by University of British Columbia at 1 site in Canada.
Trial summary
Long QT Syndrome (LQTS) is a disease of young adults and can affect women of child bearing age. Suffers of LQTS are at risk of ventricular dysrhythmias including torsades de pointes and ventricular fibrillation. Pregnancy increases the chance that any mother may have an abnormal heart rhythm or arrhythmia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Long QT Syndrome
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Apr 2008
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women managed at St. Paul's or BC Women's, Vancouver, who have been pregnant in the last 5 years
Who may be able to join
- Pregnant women with diagnoses of Long QT Syndrome, Romano Ward and Jervell - Lange Nielson Syndrome who delivered at BC Women's Hospital or St Paul's Hospital.
Who cannot join
- Non consent to participation in the study
- Age less than 19
- Non English speaker
Trial locations and contacts
1 site in 1 country.
About this study
Long QT Syndrome (LQTS) is a disease of young adults and can affect women of child bearing age. Suffers of LQTS are at risk of ventricular dysrhythmias including torsades de pointes and ventricular fibrillation.
Pregnancy increases the chance that any mother may have an abnormal heart rhythm or arrhythmia. This chance is higher with the LQTS. There are only a few reported cases of women with the LQTS having a baby in the medical literature. This can make it difficult for the doctor caring for a pregnant woman with the long QT syndrome - especially should they need an anesthetic.
We would like to study as many women who have had a baby who have the long QT syndrome to give us a better idea of whether there are any arrhythmias occurring at the time of delivery.
Read the detailed description
This will be a retrospective analysis of all LQTS women managed at St. Paul's or BC Women's who have been pregnant in the last 5 years. These two hospitals both have a provincial role in the care of pregnant women, BC Women's as the designated provincial tertiary maternity care referral centre, and St. Paul's through its provincial PATCH clinic. Using the data from these two centres should capture the majority of LQTS cases in parturients in the province. We will search for these women from the Department of Anesthesia BC Women's consult database, the St. Paul's Cardiac Obstetrical Care database, and BC Women's Health Records using International Classification of Diseases - 10 coding for long QT. Then, after obtaining patient consent, review the charts collecting data using the data entry form. The cases will then be compared and any conclusions into the different anesthetic managements made.
- Conditions
- Long QT Syndrome
- Keywords
- Long QT Syndrome, Romano Ward, Jervell-Lange Nielson Syndrome
- Medical subject headings
- Long QT Syndrome, Jervell-Lange Nielsen Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJun 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long QT SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Roanne Preston, MD, Principal investigator, University of British ColumbiaElizabeth Drake, MD, Study director, University of British ColumbiaJoanne Douglas, MD, Study director, University of British ColumbiaMarla Kiess, MD, Study director, University of British ColumbiaStanley Tung, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488254
- Sponsor's protocol ID
- H06-03385
- Status last verified
- Apr 2011
- First submitted
- 18 Jun 2007
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long QT Syndrome in Pregnancy
- ClinicalTrials.gov ID
- NCT00488254
- Acronym / sponsor ID
- H06-03385
- Conditions
- Long QT Syndrome
- Keywords
- Long QT Syndrome, Romano Ward, Jervell-Lange Nielson Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Jun 2007 (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.
Long QT Syndrome (LQTS) is a disease of young adults and can affect women of child bearing age. Suffers of LQTS are at risk of ventricular dysrhythmias including torsades de pointes and ventricular fibrillation.
Pregnancy increases the chance that any mother may have an abnormal heart rhythm or arrhythmia. This chance is higher with the LQTS. There are only a few reported cases of women with the LQTS having a baby in the medical literature. This can make it difficult for the doctor caring for a pregnant woman with the long QT syndrome - especially should they need an anesthetic.
We would like to study as many women who have had a baby who have the long QT syndrome to give us a better idea of whether there are any arrhythmias occurring at the time of delivery.
Detailed description
This will be a retrospective analysis of all LQTS women managed at St. Paul's or BC Women's who have been pregnant in the last 5 years. These two hospitals both have a provincial role in the care of pregnant women, BC Women's as the designated provincial tertiary maternity care referral centre, and St. Paul's through its provincial PATCH clinic. Using the data from these two centres should capture the majority of LQTS cases in parturients in the province. We will search for these women from the Department of Anesthesia BC Women's consult database, the St. Paul's Cardiac Obstetrical Care database, and BC Women's Health Records using International Classification of Diseases - 10 coding for long QT. Then, after obtaining patient consent, review the charts collecting data using the data entry form. The cases will then be compared and any conclusions into the different anesthetic managements made.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women managed at St. Paul's or BC Women's, Vancouver, who have been pregnant in the last 5 years
Key inclusion criteria (1 listed)
- Pregnant women with diagnoses of Long QT Syndrome, Romano Ward and Jervell - Lange Nielson Syndrome who delivered at BC Women's Hospital or St Paul's Hospital.
Key exclusion criteria (3 listed)
- Non consent to participation in the study
- Age less than 19
- Non English speaker
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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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.
Roanne Preston, MD principal investigator
University of British Columbia
Elizabeth Drake, MD study director
University of British Columbia
Joanne Douglas, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long QT Syndrome, run by University of British Columbia at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 14 Apr 2011.