Cardiac Ion ChannelopathyNCT01120886
Post-mortem Genetic Testing
An observational study of Cardiac Ion Channelopathy, run by Thayyil, Sudhin at 2 sites in United Kingdom.
Trial summary
This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births. Read more about this study
- Who is it for?
- Ages 24 to 42 weeks
- Conditions the study is for
- Cardiac Ion Channelopathy
- How many people
- 100 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2011to Mar 2013
- 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 24 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Unexplained still births
Who may be able to join
- Unexplained still births,
- No cause of death after detailed autopsy
Who cannot join
- Lack of parental consent
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Great Ormond Street Hospital
London
Southampton University Hospital
Southampton
About this study
Official title: Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births
This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.
- Conditions
- Cardiac Ion Channelopathy
- Keywords
- Ion channelopathy,, Still birth, Sudden death
- Medical subject headings
- Stillbirth, Death, Sudden
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiac ion channelopathy mutation
Measured: 6 months
Secondary outcomes (1)
Incidence of cardiac ion channelopathy in 1st degree relatives of index case
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Ion ChannelopathyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thayyil, Sudhin
- Responsible party
- Principal investigator, Sudhin Thayyil, Thayyil, Sudhin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120886
- Sponsor's protocol ID
- 48699
- Status last verified
- Apr 2013
- First submitted
- 7 May 2010
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Munroe PB, Addison S, Abrams DJ, Sebire NJ, Cartwright J, Donaldson I, Cohen MM, Mein C, Tinker A, Harmer SC, Aziz Q, Terry A, Struebig M, Warren HR, Vadgama B, Fowler DJ, Peebles D, Taylor AM, Lally PJ, Thayyil S. Postmortem Genetic Testing for Cardiac Ion Channelopathies in Stillbirths. Circ Genom Precis Med. 2018 Jan;11(1):e001817. doi: 10.1161/CIRCGEN.117.001817. Epub 2018 Jan 11.
PubMed 29874177
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births
- ClinicalTrials.gov ID
- NCT01120886
- Acronym / sponsor ID
- 48699
- Conditions
- Cardiac Ion Channelopathy
- Keywords
- Ion channelopathy,, Still birth, Sudden death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thayyil, Sudhin
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 May 2010 (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 is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Unexplained still births
Key inclusion criteria (2 listed)
- Unexplained still births,
- No cause of death after detailed autopsy
Key exclusion criteria (1 listed)
- Lack of parental consent
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
Incidence of cardiac ion channelopathy mutation
Time frame: 6 months
1 secondary outcome
Incidence of cardiac ion channelopathy in 1st degree relatives of index case
Time frame: 12 months
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 22 Apr 2013.
- Derived from this study: PubMed 29874177Munroe PB, Addison S, Abrams DJ, Sebire NJ, Cartwright J, Donaldson I, Cohen MM, Mein C, Tinker A, Harmer SC, Aziz Q, Terry A, Struebig M, Warren HR, Vadgama B, Fowler DJ, Peebles D, Taylor AM, Lally PJ, Thayyil S. Postmortem Genetic Testing for Cardiac Ion Channelopathies in Stillbirths. Circ Genom Precis Med. 2018 Jan;11(1):e001817. doi: 10.1161/CIRCGEN.117.001817. Epub 2018 Jan 11.
- Institute for Women's HealthLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Ion Channelopathy, run by Thayyil, Sudhin at 2 sites in United Kingdom.
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 2 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: finished, as of the sponsor's last update on 22 Apr 2013. 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 United Kingdom. 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.
What does the primary outcome measure?
Incidence of cardiac ion channelopathy mutation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01120886, which also lists 1 linked publication.
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 22 Apr 2013.