Molecular Mechanism Identification in Inherited Arrhythmi... | NCT01734356

Studies
Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells

NCT01734356

Sponsor

Nantes University Hospital

Status

Terminated

Last Update Posted

Nov 7, 2014Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Inherited Arrhythmias and Valvulopathies

Interventions

Skin biopsies

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Nov 22, 2012

First Submission Date that Met QC Criteria

Nov 22, 2012

First Posted Date

Nov 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2014

Last Update Posted Date

Nov 7, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Skin biopsies	Other		controle inherited arrhythmias valvulopathies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient

Secondary Outcomes

Measure	Description	Time Frame
Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vincent PROBST	Nantes UH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital		Nantes			France

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided