Circulating Endothelial Progenitor Cells and Aortic Aneurysm | NCT01918982

Studies
Circulating Endothelial Progenitor Cells and Aortic Aneurysm

NCT01918982

Sponsor

Hopital Jean Minjoz

Status

Unknown status

Last Update Posted

Aug 8, 2013Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

- Aortic Aneurysm

Interventions

Not provided

Countries

Not provided

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Feb 2016Estimated

Completion Date

May 2016Estimated

First Submitted Date

Aug 6, 2013

First Submission Date that Met QC Criteria

Aug 7, 2013

First Posted Date

Aug 8, 2013Estimated

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

Aug 7, 2013

Last Update Posted Date

Aug 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.

Detailed Description

Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level. 40 patients followed for known aortic aneurysm >30mm and <50mm will be followed up every 6 months during 2 years. Each 6 months they will have a consultation by their physiologist with an echo or a CT-scan. At the same time, a 10ML blood sample will be taken to assess the circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
Aortic aneurysm		Patients with aortic aneurysm >30mm and < 50mm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood concentration	Patients are followed for 2 years	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aortic aneurysm size >30mm and > 50mm

Exclusion Criteria:

Infectious disease
Inflammatory disease
Liver insuffisency
Cancer evolutive
Pregnant women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with aortic aneurysm

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sidney Chocron	Contact	+33381533121		sidney.chocron@univ-fcomte.fr

Overall Officials

Name	Affiliation	Role
Sidney Chocron, MD, PhD	Université de Franche-comté. France	Principal Investigator
Andrea Perrotti, MD	Université de Franche-Comté. France	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21481600	Background	Parietti E, Pallandre JR, Deschaseaux F, Aupecle B, Durst C, Kantelip JP, Chocron S, Davani S. Presence of circulating endothelial progenitor cells and levels of stromal-derived factor-1alpha are associated with ascending aorta aneurysm size. Eur J Cardiothorac Surg. 2011 Jul;40(1):e6-12. doi: 10.1016/j.ejcts.2011.02.065. Epub 2011 Apr 9.

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases