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

Preeclampsia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190177
• Other study ID #: P020925
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 17, 2013
• Start date: March 2003
• Est. completion date: October 2007

Study information

• Verified date: September 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
France	Hôpital Louis Mourier AP-HP	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France,