NCT01734356

Brief Summary

The recent developments of research on iPS (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with genetic and cellular characteristics of the donors. These cells represent a biological material more readily available to identify the pathophysiological mechanisms involved in the diseases of BrS or ERS patients, which will lead to the identification of genetic markers.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

3 years

First QC Date

November 22, 2012

Last Update Submit

November 6, 2014

Conditions

Inherited Arrhythmias and Valvulopathies

Keywords

iPSfibroblastarrhythmiasvalvulopathieselectrophysiologygenetics

Outcome Measures

Primary Outcomes (1)

  • Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient

Secondary Outcomes (1)

  • Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy

Study Arms (3)

inherited arrhythmias

OTHER

6 patient with inherited arrhythmias

Other: Skin biopsies

valvulopathies

OTHER

6 patient with valvulopathies

Other: Skin biopsies

controle

OTHER

8 healthy people for these pathologies

Other: Skin biopsies

Interventions

Skin biopsiesOTHER
controleinherited arrhythmiasvalvulopathies

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient with a family history of inherited arrhythmia or valvulopathy
  • Age : 22-60 yo.
  • patient no confine to bed
  • Male or female
  • Written consent
  • Patient affiliated to the French social security

You may not qualify if:

  • Pregnant woman
  • Patient under 22 yo or adults under guardianship
  • Indication against local anesthesia
  • Anticoagulant treatment
  • Absence or positivity of HIV, HBV, HCV serology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent PROBST

    Nantes UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2012

First Posted

November 27, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 7, 2014

Record last verified: 2014-11

Locations

FR(1)