NCT01918969

Brief Summary

Circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. However reference values have not yet been determined. This study is aimed to determine reference values of CD34+144+CD14- et CD34+VEGF-R2+CD14- in healthy men and women blood donors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 8, 2013

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

August 6, 2013

Last Update Submit

August 7, 2013

Conditions

Aortic Aneurysm

Keywords

Endothelial progenitor cellsHealthy blood donors

Outcome Measures

Primary Outcomes (1)

  • Concentration of circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14-

    3 months

Secondary Outcomes (1)

  • Ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells

    3 months

Study Arms (1)

Blood donors

Blood donors with no exclusion criteria i.e with a very low probability to have an aortic aneurysm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy blood donors

You may qualify if:

  • Blood donors

You may not qualify if:

  • age over 65
  • Arterial hypertension (treated or not)
  • Vascular disease
  • smoker or former smoker who stopped smoking for less than a year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25030, France

Location

Related Publications (1)

  • 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.

    PMID: 21481600BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Andrea Perrotti, MD

    University of Franche-Comte; France

    PRINCIPAL INVESTIGATOR

  • Pascal Morel, MD, PhD

    Etablissement Français du Sang

    PRINCIPAL INVESTIGATOR

  • Siamak Davani, MD, PhD

    University of Franche-Comte. france

    STUDY CHAIR

Central Study Contacts

Sidney Chocron, MD, PhD

CONTACT

+33381533121sidney.chocron@univ-fcomte.fr

Sidney Chocron, MD,PhD

CONTACT

+33381533121sidney.chocron@univ-fcomte.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 8, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

August 8, 2013

Record last verified: 2013-08

Locations

FR(1)