Follow up of Patients With Aortic Aneurysm by Dosage of C... | NCT02919709

Studies
Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells

NCT02919709

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Unknown status

Last Update Posted

Jul 18, 2018Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment

Interventions

blood taking

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Nov 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Sep 27, 2016

First Submission Date that Met QC Criteria

Sep 27, 2016

First Posted Date

Sep 29, 2016Estimated

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

Jul 17, 2018

Last Update Posted Date

Jul 18, 2018Actual

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

The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
thoracic or abdominal aortic aneurysm	Experimental		Biological: blood taking

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood taking	Biological		thoracic or abdominal aortic aneurysm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progenitor cells CD34+ blood levels		At diagnosis of aneurysm
progenitor cells CD34+ blood levels		6 month after disgnosis
progenitor cells CD34+ blood levels		12 month after diagnosis
progenitor cells CD34+ blood levels		18 month after diagnosis
progenitor cells CD34+ blood levels		24 month after diagnosis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 18 or more.
Patients diagnosed with a thoracic or abdominal aortic aneurysm with no indication for surgical treatment (diameters > 30 mm but < 50 mm).
Patients accepting to sign a specific informed consent.

Exclusion Criteria:

Unstable coronary artery disease.
Congenital heart disease.
Any evolving infectious syndrome or viral infection (HIV, HBV or HCV).
Any chronic inflammatory or autoimmune disease.
Prior administration of G-CSF; EPO; GM-CSF.
Liver failure.
Prior oncologic disease or ongoing cancer with a life expectancy < 1 year.
Dementia.
Pregnancy.
Patients aged < 18.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea PERROTTI, MD	Contact			aperrotti@chu-besancon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Besançon	Recruiting	Besançon		25000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided