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Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells (ANOPEC 3)

Primary Purpose

Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

blood taking

About this trial

This is an interventional prevention trial for Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHRU de BesançonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thoracic or abdominal aortic aneurysm

Arm Description

Outcomes

Primary Outcome Measures

progenitor cells CD34+ blood levels

Secondary Outcome Measures

Full Information

NCT ID

NCT02919709

First Posted

September 27, 2016

Last Updated

July 17, 2018

Sponsor

Centre Hospitalier Universitaire de Besancon

1. Study Identification

Unique Protocol Identification Number

NCT02919709

Brief Title

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

Acronym

ANOPEC 3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

thoracic or abdominal aortic aneurysm

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

blood taking

Primary Outcome Measure Information:

Title

progenitor cells CD34+ blood levels

Time Frame

At diagnosis of aneurysm

Title

progenitor cells CD34+ blood levels

Time Frame

6 month after disgnosis

Title

progenitor cells CD34+ blood levels

Time Frame

12 month after diagnosis

Title

progenitor cells CD34+ blood levels

Time Frame

18 month after diagnosis

Title

progenitor cells CD34+ blood levels

Time Frame

24 month after diagnosis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea PERROTTI, MD

aperrotti@chu-besancon.fr

Facility Information:

Facility Name

CHRU de Besançon

City

Besançon

ZIP/Postal Code

25000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andréa PERROTTI, MD

aperrotti@chu-besancon.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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