ECLAXIR:Search for an Association Between CX3CR1 V249I Polymorphism, Preeclampsia and Endothelial Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190177
First received: September 12, 2005
Last updated: October 17, 2013
Last verified: September 2005
  Purpose

The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele who express less CX3CR1 shoud be protected against this risk. The main objective of the study is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The secondary aims are the search of an association with the most severe forms of preeclampsia and endothelial injury.


Condition
Preeclampsia

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:


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

Estimated Enrollment: 370
Study Start Date: March 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

It is a case-control multicenter study 185 caucasian pregnant women with preeclampsia and 185 paired controls without preeclampsia will be included.

The frequency of the V249I polymorphism in african black population will be determined by studying 200 subjects (100 cases and 100 controls).

The V249I polymorphism will be identified by PCR followed by enzyme digestion. Endothelial injury will be identified using three assays : von Willebrand factor, soluble VCAM-1 and thrombomodulin plasma levels.

CX3CR1 involvement in preeclampsia would have potential diagnostic and therapeutic consequences.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • cases: pregnant woman, evolutive pregnancy, preeclampsia, caucasian, consenting to the study

Exclusion Criteria:

  • Cases:

multiple pregnancy, proteinuria > 300 mg/24h before 21th gestation week.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00190177

Locations
France
Hôpital Louis Mourier AP-HP
Colombes, France, 92701
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Laurent Mandelbrot, MD-PhD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190177     History of Changes
Other Study ID Numbers: P020925
Study First Received: September 12, 2005
Last Updated: October 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on September 18, 2014