ArteriosclerosisATH-ENTENCT00674531
Detection of Enterovirus RNA in Atheromatous Lesions
A study testing Artery resection in people with Arteriosclerosis, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriosclerosis
- What is being tested?
- Artery resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2008to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of artery resection
- affiliated or a beneficiary of a social security category
- having signed the inform consent form
Who cannot join
- pregnant women
- contra-indication to clamping
- scheduled resection at friday after-noon, week-end or legal holidays
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
CHU de Grenoble
Grenoble, 38000
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: 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.
Read the 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.
- Conditions
- Arteriosclerosis
- Being tested
- Artery resection
- Keywords
- Arteriosclerosis, Arterial Occlusive Diseases, Enterovirus, Artery resection
- Medical subject headings
- Arteriosclerosis, Arterial Occlusive Diseases, Enterovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artery resectionProcedure or surgery
Artery resection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Enterovirus RNA analysis Receives: Procedure: Artery resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prévalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with sound carotid artery
Measured: artery resection
Secondary outcomes (5)
Prevalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with sound vein
Measured: Artery resection
Prevalence of detection of enteroviral RNA by RT-PCR in sound carotid artery in comparison with sound vein
Measured: Artery resection
Prevalence of detection of enteroviral RNA by RT-PCR in calm and active atherosclerotic lesions
Measured: Artery resection
Prevalence of detection of antibodies between different groups of patients.
Measured: Artery resection
Prevalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with circulating blood
Measured: Artery resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Xavier BARRAL, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674531
- Sponsor's protocol ID
- 0608071
- Other IDs
- 2007-A00895-48, DGS2007-0534
- Acronym
- ATH-ENTE
- Status last verified
- Oct 2014
- First submitted
- 7 May 2008
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Schanen C, Nasri D, Bourlet T, Barral X, Favre JP, Bourrat D, Peoc'h M, Ginevra C, Andreoletti L, Pozzetto B, Pillet S. Enterovirus in arteriosclerosis: a pilot study. J Clin Virol. 2007 Jun;39(2):106-12. doi: 10.1016/j.jcv.2007.03.014. Epub 2007 May 10.
PubMed 17499019Andreoletti L, Venteo L, Douche-Aourik F, Canas F, Lorin de la Grandmaison G, Jacques J, Moret H, Jovenin N, Mosnier JF, Matta M, Duband S, Pluot M, Pozzetto B, Bourlet T. Active Coxsackieviral B infection is associated with disruption of dystrophin in endomyocardial tissue of patients who died suddenly of acute myocardial infarction. J Am Coll Cardiol. 2007 Dec 4;50(23):2207-14. doi: 10.1016/j.jacc.2007.07.080. Epub 2007 Nov 19.
PubMed 18061067
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Enterovirus RNA by RT-PCR in Atheromatous Lesions
- ClinicalTrials.gov ID
- NCT00674531
- Acronym / sponsor ID
- ATH-ENTE / 0608071
- Conditions
- Arteriosclerosis
- Keywords
- Arteriosclerosis, Arterial Occlusive Diseases, Enterovirus, Artery resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Artery resectionEnterovirus RNA analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication of artery resection
- affiliated or a beneficiary of a social security category
- having signed the inform consent form
Key exclusion criteria (3 listed)
- pregnant women
- contra-indication to clamping
- scheduled resection at friday after-noon, week-end or legal holidays
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artery resectionArtery resection | Procedure or surgery | 1 |
Primary outcome
Prévalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with sound carotid artery
Time frame: artery resection
5 secondary outcomes
Prevalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with sound vein
Time frame: Artery resection
Prevalence of detection of enteroviral RNA by RT-PCR in sound carotid artery in comparison with sound vein
Time frame: Artery resection
Prevalence of detection of enteroviral RNA by RT-PCR in calm and active atherosclerotic lesions
Time frame: Artery resection
Prevalence of detection of antibodies between different groups of patients.
Time frame: Artery resection
Prevalence of detection of enteroviral RNA by RT-PCR in atherosclerotic carotid artery in comparison with circulating blood
Time frame: Artery resection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
- Background: PubMed 17499019Schanen C, Nasri D, Bourlet T, Barral X, Favre JP, Bourrat D, Peoc'h M, Ginevra C, Andreoletti L, Pozzetto B, Pillet S. Enterovirus in arteriosclerosis: a pilot study. J Clin Virol. 2007 Jun;39(2):106-12. doi: 10.1016/j.jcv.2007.03.014. Epub 2007 May 10.
- Background: PubMed 18061067Andreoletti L, Venteo L, Douche-Aourik F, Canas F, Lorin de la Grandmaison G, Jacques J, Moret H, Jovenin N, Mosnier JF, Matta M, Duband S, Pluot M, Pozzetto B, Bourlet T. Active Coxsackieviral B infection is associated with disruption of dystrophin in endomyocardial tissue of patients who died suddenly of acute myocardial infarction. J Am Coll Cardiol. 2007 Dec 4;50(23):2207-14. doi: 10.1016/j.jacc.2007.07.080. Epub 2007 Nov 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier BARRAL, MD PhD principal investigator
CHU de Saint-Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artery resection in people with Arteriosclerosis, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00674531, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.