ClinicalTrials.gov
ClinicalTrials.gov Menu

Circulating Endothelial Compartment During Normal and Pathological Aging (VIMOPEIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01038700
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : October 1, 2015
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

Brief Summary:
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 or disease
Healthy

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 84 participants
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
Study Start Date : December 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2010



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Transcriptome analysis on EPC isolated from cord blood and peripheral blood from young and old adults [ Time Frame: end ]

Biospecimen Retention:   Samples Without DNA
whole blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Senior)
Sexes 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

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