Detection of Enterovirus RNA in Atheromatous Lesions (ATH-ENTE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Arteriosclerosis |
Procedure: Artery resection |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Detection of Enterovirus RNA by RT-PCR in Atheromatous Lesions |
- 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 ]
- 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 ]
| Enrollment: | 100 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Enterovirus RNA analysis
|
Procedure: Artery resection
Artery resection
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| CHU de Clermont-Ferrand | |
| Clermont-ferrand, France, 63000 | |
| CHU de Grenoble | |
| Grenoble, France, 38000 | |
| CHU de Saint-Etienne | |
| Saint-etienne, France, 42055 | |
| Principal Investigator: | Xavier BARRAL, MD PhD | CHU de Saint-Etienne |
More Information
Publications:
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT00674531 History of Changes |
| Other Study ID Numbers: | 0608071, 2007-A00895-48, DGS2007-0534 |
| Study First Received: | May 7, 2008 |
| Last Updated: | September 14, 2012 |
| Health Authority: | France: Direction Générale de la Santé France: French Data Protection Authority |
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
|
Arteriosclerosis Arterial Occlusive Diseases Enterovirus Artery resection |
Additional relevant MeSH terms:
|
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013