Detection of Enterovirus RNA in Atheromatous Lesions (ATH-ENTE)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00674531
First received: May 7, 2008
Last updated: October 8, 2014
Last verified: October 2014

May 7, 2008
October 8, 2014
January 2008
March 2014   (final data collection date for primary outcome measure)
Prévalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with sound carotid artery [ Time Frame: artery resection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00674531 on ClinicalTrials.gov Archive Site
  • Prevalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with sound vein [ Time Frame: Artery resection ] [ Designated as safety issue: No ]
  • Prevalence of detection of enteroviral RNA by RT-PCR in sound carotid artery in comparison with sound vein [ Time Frame: Artery resection ] [ Designated as safety issue: No ]
  • Prevalence of detection of enteroviral RNA by RT-PCR in calm and active atherosclerotic lesions [ Time Frame: Artery resection ] [ Designated as safety issue: No ]
  • Prevalence of detection of antibodies between different groups of patients. [ Time Frame: Artery resection ] [ Designated as safety issue: No ]
  • Prevalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with circulating blood [ Time Frame: Artery resection ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Detection of Enterovirus RNA in Atheromatous Lesions
Detection of Enterovirus RNA by RT-PCR in Atheromatous Lesions

Atherosclerosis is one of the first causes of morbidity-mortality in industrialized countries. Numerous works suggest that some infectious agents could be involved in the inflammatory process leading to the development of this pathology, such as Chlamydophila pneumoniae, cytomegalovirus or herpes simplex virus. Enteroviruses are small RNA viruses that have been incriminated in various acute or chronic cardiac diseases (pericarditis, myocarditis, dilated cardiomyopathy) and exhibit a tropism for vascular endothelia. Different clinical and experimental arguments suggest that they could play a cofactor role in the occurrence or maintenance of atherosclerosis lesions. A multicenter study developed in collaboration with colleagues of the University Hospital of Reims (France) showed that it was frequent to detect enterovirus RNA in cardiac biopsies from patients with myocardial infarction. Furthermore, a pilot study conducted in the University Hospital of Saint-Etienne (France) on atheromatous arterial samples from 18 patients allowed the detection of enterovirus RNA in 20% of them.

Objective: In order to complete these data and to answer clearly to the question of the role of persistent infection by enteroviruses in atherosclerosis, we propose this research program involving the Departments of Vascular Surgery of three University hospitals of the "Rhône-Alpes" region and of three laboratories of Virology interested by the relationship between chronic diseases and enterovirus infection..

Methods: It is projected to include about one hundred voluntary adults exhibiting carotid atheromatous lesions requiring a surgical removal. Because of the difficulty to define a pertinent control group, each patient will be his/her own control. In addition to the fragment of pathologic carotid, it will be taken arterial and venous fragments from vessels that are never the seat of atherosclerosis lesions. To reach the best sensitivity, enterovirus RNA will be detected by nested RT-PCR.

Evaluation criteria: The main evaluation criterion will be the percentage of detection of enterovirus RNA by RT-PCR in atheromatous lesions by comparison to control arteries by Mac-Nemar test. These results will be correlated to anatomic and histological lesions of the atheromatous plaques. Other markers will be analysed secondarily: detection of enterovirus RNA in control venous samples, detection of stigmata of viral replication by immunochemistry or detection of negative RNA strands, analysis of the antibody response to enterovirus in blood, molecular typing of enteroviruses detected in the lesions… Expected benefits: This study should allow to better understand the putative involvement of enteroviruses in atherosclerosis-linked diseases. If the hypothesis of a relationship was confirmed, a more ambitious research project would be proposed in order to investigate the mechanisms by which enterovirus can favour atherosclerosis and to discuss the opportunity of preventive strategies (notably vaccination) to reduce the risk.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Arteriosclerosis
Procedure: Artery resection
Artery resection
1
Enterovirus RNA analysis
Intervention: Procedure: Artery resection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Indication of artery resection
  • affiliated or a beneficiary of a social security category
  • having signed the inform consent form

Exclusion Criteria:

  • pregnant women
  • contra-indication to clamping
  • scheduled resection at friday after-noon, week-end or legal holidays
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00674531
0608071, 2007-A00895-48, DGS2007-0534
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Xavier BARRAL, MD PhD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP