Arterial StiffnessRAIPAoNCT06151054
Relationship Between Aortic Parietal Inflammation on 18F-FDG PET Scan and Arterial Stiffness as a Function of Age
An observational study of Arterial Stiffness, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Arterial Stiffness
- What is being tested?
- Measure of aortic inflammation
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2022to 6 Dec 2022
- How long will I take part?
- 2 Years
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent whole-body 18F-FDG PET/CT included in the PACTEP study and in this context, who had an assessment of arterial stiffness by applanation tonometer
Who may be able to join
- Patients who underwent whole-body 18F-FDG PET/CT included in the PACTEP study
- Patient with an assessment of arterial stiffness by applanation tonometer
Who cannot join
- patients without an assessment of arterial stiffness by applanation tonometer
Trial locations and contacts
1 site in 1 country.
About this study
Show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.
Read the detailed description
In the literature, a relationship has been demonstrated between local inflammation in the aortic wall and increased arterial stiffness. Arterial stiffness is commonly represented by pulse wave velocity (PWV) measured using an applanation tonometer. It would seem that this parietal inflammation precedes arterial stiffness and consequently, arterial hypertension . Arterial stiffness is an important factor of cardiovascular morbidity and mortality and therefore represents a major public health interest in prevention in the face of the continuous aging of our population . This study will consist in studying on a population divided into three age groups, less than 40 years old, 40 to 60 years old and more than 60 years old, the relationship between thoracic aortic parietal inflammation evaluated using the Standard Uptake Value parameters (SUV) and Hounsfield units (HU) measured on 18F-FDG PET/CT scans performed between 09/04/2018 and 11/06/2020 and arterial stiffness parameters. We will seek to show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.
- Conditions
- Arterial Stiffness
- Being tested
- Measure of aortic inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of aortic inflammationDiagnostic test
Standard Uptake Value (SUV) measures of aortic wall
What is being measured
The primary outcome is the main question the study is designed to answer.
to etablish a relationship inflammation of aortic wall and arterial stiffness
Standard Uptake Value
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start30 Oct 2022
- Primary completion30 Nov 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 89 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Yves MARIE, Central Hospital, Nancy, France
- Investigators
- Anne-Sophie HUE, MSc, Study director, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151054
- Sponsor's protocol ID
- 2022PI141
- Acronym
- RAIPAo
- Status last verified
- Nov 2023
- First submitted
- 8 Sep 2022
- Last updated
- 30 Nov 2023
- 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Aortic Parietal Inflammation on 18F-FDG PET Scan and Arterial Stiffness as a Function of Age
- ClinicalTrials.gov ID
- NCT06151054
- Acronym / sponsor ID
- RAIPAo / 2022PI141
- Conditions
- Arterial Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 30 Nov 2023 (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.
Show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.
Detailed description
In the literature, a relationship has been demonstrated between local inflammation in the aortic wall and increased arterial stiffness. Arterial stiffness is commonly represented by pulse wave velocity (PWV) measured using an applanation tonometer. It would seem that this parietal inflammation precedes arterial stiffness and consequently, arterial hypertension . Arterial stiffness is an important factor of cardiovascular morbidity and mortality and therefore represents a major public health interest in prevention in the face of the continuous aging of our population . This study will consist in studying on a population divided into three age groups, less than 40 years old, 40 to 60 years old and more than 60 years old, the relationship between thoracic aortic parietal inflammation evaluated using the Standard Uptake Value parameters (SUV) and Hounsfield units (HU) measured on 18F-FDG PET/CT scans performed between 09/04/2018 and 11/06/2020 and arterial stiffness parameters. We will seek to show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent whole-body 18F-FDG PET/CT included in the PACTEP study and in this context, who had an assessment of arterial stiffness by applanation tonometer
Key inclusion criteria (2 listed)
- Patients who underwent whole-body 18F-FDG PET/CT included in the PACTEP study
- Patient with an assessment of arterial stiffness by applanation tonometer
Key exclusion criteria (1 listed)
- patients without an assessment of arterial stiffness by applanation tonometer
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 |
|---|---|---|
| Measure of aortic inflammationStandard Uptake Value (SUV) measures of aortic wall | Diagnostic test | – |
Primary outcome
to etablish a relationship inflammation of aortic wall and arterial stiffness
Time frame: 1 day
Standard Uptake Value
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 30 Nov 2023.
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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.
Anne-Sophie HUE, MSc study director
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Stiffness, run by Central Hospital, Nancy, France at 1 site 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 2 inclusion and 1 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
to etablish a relationship inflammation of aortic wall and arterial stiffness (time frame: 1 day). 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 30 Nov 2023; AzTrials last refreshed its copy on 4 Nov 2026.