Post-mortem Genetic Testing

Cardiac Ion Channelopathy Clinical Trial

Official title:

Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120886
• Other study ID #: 48699
• Status: Completed
• Phase: N/A
• First received: May 7, 2010
• Last updated: April 19, 2013
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Thayyil, Sudhin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 42 Weeks

Eligibility

Inclusion Criteria:

• Unexplained still births,

• No cause of death after detailed autopsy

Exclusion Criteria:

• Lack of parental consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Ion Channelopathy
• Channelopathies

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital	London
United Kingdom	Southampton University Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Thayyil, Sudhin

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiac ion channelopathy mutation		6 months	No
Secondary	Incidence of cardiac ion channelopathy in 1st degree relatives of index case		12 months	No