Abdominal Aorta AneurismNCT03767023
Clinical and Microbiological Relationships Between Periodontitis and Abdominal Aorta Aneurism: an Case Control Study
An observational study of Abdominal Aorta Aneurism and Periodontitis, run by University of Liege.
Trial summary
Aorta Abdominal aneurism (AAA) is a chronic degenerative disorder leading to the dilation and eventually to the rupture of the aortic wall. The pathology presents risk factors such as aging, atherosclerosis, male gender, cigarette smoking, pulmonary emphysema and high blood pressure.The vascular wall destruction is… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aorta Aneurism, Periodontitis, Dentulous
- What is being tested?
- cross sectional
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Mar 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from the Cardiovascular Surgery Department, University Hospital of Liège (Belgium) and presenting AAA were screened in order to include 31 patients in each group (stable versus instable AAA) according to the sample size calculation. Sixty-two patients were therefore included according to the following inclusion and exclusion criteria:
Who may be able to join
- AAA
- dentulous
- ability to come in Hospital
Who cannot join
- diseases of connective tissue: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerodermia, Crohn disease, Marfan syndrome, Heler Danlos syndrome, polymyosite/dermatomyosite, mix connectivite (MCDT)
- aneurysms of the lower limbs (femoral or popliteal)
- contraindication to the scanner
- participation of another clinical trial 30 days before baseline
- patient with risk oslerien
- taking antibiotics during the 3 months preceding the inclusion
- obese patients (BMI ≥ 30 kg/m2)
- immunosuppressant drugs or chemotherapy
About this study
Aorta Abdominal aneurism (AAA) is a chronic degenerative disorder leading to the dilation and eventually to the rupture of the aortic wall. The pathology presents risk factors such as aging, atherosclerosis, male gender, cigarette smoking, pulmonary emphysema and high blood pressure.The vascular wall destruction is characterized by a remodeling of the extracellular matrix (ECM), the presence of an inflammatory infiltrate of macrophages and lymphocytes associated increase in production of MMPs. A similar destruction mechanisms is found in periodontitis a chronic inflammatory diseases characterized by gram-negative bacteria species that are able to degrade ECM of the tooth supporting tissues and leading finally to tooth loss .Moreover, relationships between periodontitis and cardiovascular disease have already been demonstrated. These associations are considered to be initiated by transient or prolonged bacteremia due to dissemination of oral bacteria or their products into the bloodstream . The periopathogens, more specifically Porphyromonas gingivalis (Pg), were observed in atherosclerosis and aneurysm specimens as well as in coronary heart disease and endocarditis The association between periodontitis and Abdominal Aortic Aneurysms (AAA) has not often been studied especially from a clinical aspect. The mechanisms that induce the initiation, the development or the recurrence and the rupture of AAA after a period of quiescence not well studied and are therefore still unknown.
The aim of this clinical observational case controlled study is to search for a possible relationship between periodontal disease and rapid growth of AAA. Patients presenting stable or unstable AAA will be screened for the degree of periodontitis, for the type of oral microbiology and periodontopathogen markers present in the blood stream.
Read the detailed description
31 consecutive dentulous patients diagnosed for AAA requiring a cardiovascular surgery (instable AAA) and 31 consecutive dentulous patients with stable AAA (no need for cardiovascular surgery) will be recruited from the Cardiovascular Surgery Department of the University Hospital of Liège (Faculty of Medicine, University of Liège, Belgium - Pr. N. Sakalihasan). The 62 patients will be subjected to:
- Full clinical periodontal parameter assessment
- Microbiological analyses of saliva,
- Supra- and sub- gingival microbiological test
- Blood test for biomarker analysis.
- Imaging (echography, CT-Scans)measurments
- Conditions
- Abdominal Aorta Aneurism, Periodontitis, Dentulous
- Being tested
- cross sectional
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross sectionalOther
| Study group | Role | What they receive |
|---|---|---|
| Stable AAA | = patients with a small abdominal aortic aneursym diameter < 55 mm " Receives: Other: cross sectional | |
| instable AAA | =patients with a large abdominal aortic aneursym diameter > 55 mm and/or AAA with rapid growth who needs open surgery or EndoVascular Aneurysm Repair "EVAR Receives: Other: cross sectional |
What is being measured
The primary outcome is the main question the study is designed to answer.
pocked depth correlated with AAA stability
Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with AAA stability.
Measured: june 2017
Secondary outcomes (1)
pocked depth correlated with abdominal aortic aneurysm diametres such as anterior -posterior
Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with abdominal aortic aneurysm diametres such as anterior -posterior (AP,millimeter)
Measured: March 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study startFeb 2015
- Primary completionJun 2015
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aorta AneurismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, Leila Salhi, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767023
- Sponsor's protocol ID
- H2014-3 AAA
- Status last verified
- Dec 2018
- First submitted
- 26 Oct 2018
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Relationships Between Periodontitis and Abdominal Aorta Aneurism: an Case Control Study
- ClinicalTrials.gov ID
- NCT03767023
- Acronym / sponsor ID
- H2014-3 AAA
- Conditions
- Abdominal Aorta Aneurism, Periodontitis, Dentulous
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Feb 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 6 Dec 2018 (actual)
- 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.
Aorta Abdominal aneurism (AAA) is a chronic degenerative disorder leading to the dilation and eventually to the rupture of the aortic wall. The pathology presents risk factors such as aging, atherosclerosis, male gender, cigarette smoking, pulmonary emphysema and high blood pressure.The vascular wall destruction is characterized by a remodeling of the extracellular matrix (ECM), the presence of an inflammatory infiltrate of macrophages and lymphocytes associated increase in production of MMPs. A similar destruction mechanisms is found in periodontitis a chronic inflammatory diseases characterized by gram-negative bacteria species that are able to degrade ECM of the tooth supporting tissues and leading finally to tooth loss .Moreover, relationships between periodontitis and cardiovascular disease have already been demonstrated. These associations are considered to be initiated by transient or prolonged bacteremia due to dissemination of oral bacteria or their products into the bloodstream . The periopathogens, more specifically Porphyromonas gingivalis (Pg), were observed in atherosclerosis and aneurysm specimens as well as in coronary heart disease and endocarditis The association between periodontitis and Abdominal Aortic Aneurysms (AAA) has not often been studied especially from a clinical aspect. The mechanisms that induce the initiation, the development or the recurrence and the rupture of AAA after a period of quiescence not well studied and are therefore still unknown.
The aim of this clinical observational case controlled study is to search for a possible relationship between periodontal disease and rapid growth of AAA. Patients presenting stable or unstable AAA will be screened for the degree of periodontitis, for the type of oral microbiology and periodontopathogen markers present in the blood stream.
Detailed description
31 consecutive dentulous patients diagnosed for AAA requiring a cardiovascular surgery (instable AAA) and 31 consecutive dentulous patients with stable AAA (no need for cardiovascular surgery) will be recruited from the Cardiovascular Surgery Department of the University Hospital of Liège (Faculty of Medicine, University of Liège, Belgium - Pr. N. Sakalihasan). The 62 patients will be subjected to:
- Full clinical periodontal parameter assessment
- Microbiological analyses of saliva,
- Supra- and sub- gingival microbiological test
- Blood test for biomarker analysis.
- Imaging (echography, CT-Scans)measurments
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable AAA | – | Other: cross sectional= patients with a small abdominal aortic aneursym diameter < 55 mm " |
| instable AAA | – | Other: cross sectional=patients with a large abdominal aortic aneursym diameter > 55 mm and/or AAA with rapid growth who needs open surgery or EndoVascular Aneurysm Repair "EVAR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the Cardiovascular Surgery Department, University Hospital of Liège (Belgium) and presenting AAA were screened in order to include 31 patients in each group (stable versus instable AAA) according to the sample size calculation. Sixty-two patients were therefore included according to the following inclusion and exclusion criteria:
Key inclusion criteria (3 listed)
- AAA
- dentulous
- ability to come in Hospital
Key exclusion criteria (8 listed)
- diseases of connective tissue: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerodermia, Crohn disease, Marfan syndrome, Heler Danlos syndrome, polymyosite/dermatomyosite, mix connectivite (MCDT)
- aneurysms of the lower limbs (femoral or popliteal)
- contraindication to the scanner
- participation of another clinical trial 30 days before baseline
- patient with risk oslerien
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 |
|---|---|---|
| cross sectional | Other | Stable AAA, instable AAA |
Primary outcome
pocked depth correlated with AAA stability
Time frame: june 2017
Periodontal clinical parameters such as pocked depth (PD, millimeter) will be correlated with AAA stability.
1 secondary outcome
pocked depth correlated with abdominal aortic aneurysm diametres such as anterior -posterior
Time frame: March 2018
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 14 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aorta Aneurism and Periodontitis, run by University of Liege.
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 8 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 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
pocked depth correlated with AAA stability (time frame: june 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2018.