Circulating Endothelial Compartment During Normal and Pathological Aging (VIMOPEIL)

This study has been completed.
Sponsor:
Collaborators:
Fondation pour la Recherche Médicale
Assistance Publique Hopitaux De Marseille
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01038700
First received: December 22, 2009
Last updated: September 30, 2015
Last verified: September 2015
  Purpose
This part of the project aims to describe changes in markers of vascular competence (Endothelial Microparticles Platelet (EMP), Circulating endothelial cells (CEC) and Circulating endothelial progenitors (EPC)) at different ages of lifespan both in physiological state and in response to hypoxia-induced vascular stress.

Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact du Vieillissement (VI) Sur le Compartiment Circulant et Sur la Mobilisation (MO) Des progéniteurs endothéliaux (PE) Par ischémie Locale (IL) : étude Pilote

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Analyse of CEC, EMP and EPC at different ages of lifespan both in physiological state and in response to an hypoxia- induced vascular stress [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transcriptome analysis on EPC isolated from cord blood and peripheral blood from young and old adults [ Time Frame: end ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
whole blood

Enrollment: 84
Study Start Date: December 2008
Study Completion Date: September 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers
Criteria

Inclusion Criteria:

  • Healthy volunteers of 20-30 and 60-70 years old
  • Non smokers male
  • Biological test in normal values : lipids, glucose, TGO, TGT, alkaline phosphatases, gamma-GT, bilirubin, creatinine, ionogram, Ca++, albumin, proteins, WBC, platelets count, coagulation tests (APTT, PT, Fibrinogen).
  • Negative HIV1 and 2, HBV (Hbs antigen) and HCV serology.
  • Normal ECG 12 derivations, arterial pressure and cardiac frequency.

Exclusion Criteria:

  • Evaluative disease in the past 10 days
  • Hemorrhagic disorders
  • Treatments with antiplatelets agents, oral or injectable anticoagulant
  • Statins, glitazones, EPO, G-CSF
  • Frequent faintness
  • Blood donation in the 3 months preceding the study
  • People in period of exclusion on the National File of the people who lend themselves to biomedical research
  • Refusal or linguistic or psychic incapacity to sign the enlightened consent
  • Biological parameters apart from the usual values of the healthy subject (Hb<10 g/dL, TGO/TGT > 2 times higher limit of normal values)
  • Prone not being able to subject to the constraints protocol (for example, not cooperating, incompetent to go to the visits of follow-up and probably incompetent to finish the study).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01038700

Locations
France
Hegp- Cic
Paris, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation pour la Recherche Médicale
Assistance Publique Hopitaux De Marseille
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: David SMADJA, PH Assistance Publique - Hôpitaux de Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yannick VACHER, Department Clinical Research of devloppement
ClinicalTrials.gov Identifier: NCT01038700     History of Changes
Other Study ID Numbers: P070801 
Study First Received: December 22, 2009
Last Updated: September 30, 2015
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Circulating endothelial compartment
microparticles
endothelial progenitors cells
circulating endothelial cells
transcriptome
aging
Healthy volunteers

ClinicalTrials.gov processed this record on July 28, 2016