Abdominal Aortic AneurysmPARISNCT03320408
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
An observational study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm, Ruptured, run by Ron Balm at 2 sites in Netherlands.
Trial summary
First aim: PARIS study The main aim of the current study is to determine the association between abdominal aortic aneurysm (AAA) progression and the evolution of proteases and cytokines levels.To achieve this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
- How many people
- 790 participants
- Where
- 2 sitesNetherlands
- Study dates
- 4 Oct 2017to 4 Aug 2023
- How long will I take part?
- 10 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with an abdominal aortic aneurysm who present themselves in the participating hospitals.
Who may be able to join
- Adult participant (18 years or older)
- Participant has an AAA or has previously been treated for an AAA
- Adequate comprehension of the Dutch language to provide written informed consent
Who cannot join
- A patient who is decisionally impaired. The only exception to this are the patients who are decisionally impaired due to the effects of an acute AAA. This particular group is eligible for which a separate recruitment and consent procedure exists.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Department of Vascular Surgery, Amsterdam UMC, location AMC
Amsterdam, 1105 AZ
Leiden University Medical Center (LUMC)
Leiden, South Holland, 2333ZA
About this study
Official title: Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers (PARIS Study) & Biobank Pearl AAA
First aim: PARIS study
The main aim of the current study is to determine the association between abdominal aortic aneurysm (AAA) progression and the evolution of proteases and cytokines levels.To achieve this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data. Aortic tissue will only be obtained when patients undergo conventional open repair. The other biomaterials will be collected during regular patient follow-up visits, with a maximum frequency of once per year.
Read more
Second aim: Pearl AAA biobank
For future research purposes, a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank. This biobank will be embedded within the infrastructure of the 'Parelsnoer Institute' (PSI) and will be called Pearl AAA. The Pearl AAA will be established in the extension of the PARIS study
Read the detailed description
The PARIS study aims to determine the correlation between AAA progression (growth or rupture) and the evolution of serum levels of proteases and cytokines over time. A repeated measures analysis will be done to use all longitudinal data available.
The Pearl AAA biobank will be established to enable the PARIS study, but also aims to facilitate future research. Such future research should fall under the scientific aims of the Pearl AAA, which are:
- To gain insight in the pathogenesis of AAA
- To gain more knowledge in the rupture risk of AAA
- To evaluate and potentially improve treatment of AAA
The 'Parelsnoer Institute' will facilitate the biobank Pearl AAA with certain aspects such as, but not limited to the following:
- Standardized operating procedures for the collection and storage of the biosamples across all participating hospitals
- Information architect to establish a data dictionary in which all variables are defined
- Standardized procedures for coding of patient data before storage
- Standardized digital infrastructure to enhance storage of patient data and imaging data
- Keywords
- biobank, pathogenesis, Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Rupture, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic AAA | These patients will be included while their AAA is asymptomatic and while they are under surveillance by their vascular surgeon. | |
| Acute AAA | These are the patients that are included while they presented in the participating hospitals because either a symptomatic or ruptured AAA. For this group, a different recruitment procedure exists which has been approved by the appropriate medical ethical committee. | |
| Repaired AAA | These patients are included while they already had had AAA repair (both elective and emergency repair). |
What is being measured
The primary outcome is the main question the study is designed to answer.
AAA growth
Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes
Measured: Up to 10 years of follow-up
AAA rupture
Rupture of an abdominal aortic aneurysm
Measured: Up to 10 years of follow-up
Death
All-cause mortality
Measured: Up to 10 years of follow-up
Evolution of serum levels of proteases
Repeated measurements analysis of serum levels of proteases in cohort of asymptomatic AAAs
Measured: a maximum of 1 measurement annually up to 10 years of follow-up
Evolution of serum levels of cytokines
Repeated measurements analysis of serum levels of cytokines in cohort of asymptomatic AAAs
Measured: a maximum of 1 measurement annually up to 10 years of follow-up
Protease levels in aortic tissue
Protease levels in aortic tissue
Measured: If open AAA repair is performed and aortic tissue is collected, protease levels will then be measured. This is a one-time measurement.
Cytokine levels in aortic tissue
Cytokine levels in aortic tissue
Measured: If open AAA repair is performed and aortic tissue is collected, cytokine levels will then be measured. This is a one-time measurement.
Secondary outcomes (2)
Type of complications after AAA repair
Type of complications using methodology from the Dutch committee of the "Nederlandse Vereniging voor Heelkunde," named the "Landelijke Heelkunde Complicatie Registratie" as found on www.lhcr.nl
Measured: Will be measured up to 10 years after AAA repair is performed
Incidence of complications after AAA repair
Number of complications after abdominal aortic aneurysm repair
Measured: Will be measured up to 10 years after AAA repair is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start4 Oct 2017
- Primary completion4 Aug 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 790 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ron Balm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ron Balm, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Ron Balm, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320408
- Sponsor's protocol ID
- NL59991.018.17
- Other IDs
- Biobank Pearl AAA
- Acronym
- PARIS
- Status last verified
- Aug 2023
- First submitted
- 12 Oct 2017
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers can initiate the procedure to request IPD for research that falls within the scientific scope of the biobank Pearl AAA.
Publications
Jalalzadeh H, Indrakusuma R, Blankensteijn JD, Wisselink W, Yeung KK, Lindeman JHN, Hamming JF, Koelemay MJW, Legemate DA, Balm R. Design and protocol of a comprehensive multicentre biobank for abdominal aortic aneurysms. BMJ Open. 2019 Aug 1;9(8):e028858. doi: 10.1136/bmjopen-2018-028858.
PubMed 31375618
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers (PARIS Study) & Biobank Pearl AAA
- ClinicalTrials.gov ID
- NCT03320408
- Acronym / sponsor ID
- PARIS / NL59991.018.17
- Keywords
- biobank, pathogenesis, Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 790 participants (actual)
- Lead sponsor
- Ron BalmUniversity, hospital or other
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 25 Oct 2017 (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.
First aim: PARIS study
The main aim of the current study is to determine the association between abdominal aortic aneurysm (AAA) progression and the evolution of proteases and cytokines levels.To achieve this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data. Aortic tissue will only be obtained when patients undergo conventional open repair. The other biomaterials will be collected during regular patient follow-up visits, with a maximum frequency of once per year.
Second aim: Pearl AAA biobank
For future research purposes, a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank. This biobank will be embedded within the infrastructure of the 'Parelsnoer Institute' (PSI) and will be called Pearl AAA. The Pearl AAA will be established in the extension of the PARIS study
Detailed description
The PARIS study aims to determine the correlation between AAA progression (growth or rupture) and the evolution of serum levels of proteases and cytokines over time. A repeated measures analysis will be done to use all longitudinal data available.
The Pearl AAA biobank will be established to enable the PARIS study, but also aims to facilitate future research. Such future research should fall under the scientific aims of the Pearl AAA, which are:
- To gain insight in the pathogenesis of AAA
- To gain more knowledge in the rupture risk of AAA
- To evaluate and potentially improve treatment of AAA
The 'Parelsnoer Institute' will facilitate the biobank Pearl AAA with certain aspects such as, but not limited to the following:
- Standardized operating procedures for the collection and storage of the biosamples across all participating hospitals
- Information architect to establish a data dictionary in which all variables are defined
- Standardized procedures for coding of patient data before storage
- Standardized digital infrastructure to enhance storage of patient data and imaging data
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic AAA | – | –These patients will be included while their AAA is asymptomatic and while they are under surveillance by their vascular surgeon. |
| Acute AAA | – | –These are the patients that are included while they presented in the participating hospitals because either a symptomatic or ruptured AAA. For this group, a different recruitment procedure exists which has been approved by the appropriate medical ethical committee. |
| Repaired AAA | – | –These patients are included while they already had had AAA repair (both elective and emergency repair). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with an abdominal aortic aneurysm who present themselves in the participating hospitals.
Key inclusion criteria (3 listed)
- Adult participant (18 years or older)
- Participant has an AAA or has previously been treated for an AAA
- Adequate comprehension of the Dutch language to provide written informed consent
Key exclusion criteria (1 listed)
- A patient who is decisionally impaired. The only exception to this are the patients who are decisionally impaired due to the effects of an acute AAA. This particular group is eligible for which a separate recruitment and consent procedure exists.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AAA growth
Time frame: Up to 10 years of follow-up
Growth of abdominal aortic aneurysm, measured on imaging made for clinical purposes
AAA rupture
Time frame: Up to 10 years of follow-up
Rupture of an abdominal aortic aneurysm
Death
Time frame: Up to 10 years of follow-up
All-cause mortality
Evolution of serum levels of proteases
Time frame: a maximum of 1 measurement annually up to 10 years of follow-up
Repeated measurements analysis of serum levels of proteases in cohort of asymptomatic AAAs
Evolution of serum levels of cytokines
Time frame: a maximum of 1 measurement annually up to 10 years of follow-up
Repeated measurements analysis of serum levels of cytokines in cohort of asymptomatic AAAs
Protease levels in aortic tissue
Time frame: If open AAA repair is performed and aortic tissue is collected, protease levels will then be measured. This is a one-time measurement.
Protease levels in aortic tissue
Cytokine levels in aortic tissue
Time frame: If open AAA repair is performed and aortic tissue is collected, cytokine levels will then be measured. This is a one-time measurement.
Cytokine levels in aortic tissue
2 secondary outcomes
Type of complications after AAA repair
Time frame: Will be measured up to 10 years after AAA repair is performed
Incidence of complications after AAA repair
Time frame: Will be measured up to 10 years after AAA repair is performed
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 22 Aug 2023.
- Derived from this study: PubMed 31375618Jalalzadeh H, Indrakusuma R, Blankensteijn JD, Wisselink W, Yeung KK, Lindeman JHN, Hamming JF, Koelemay MJW, Legemate DA, Balm R. Design and protocol of a comprehensive multicentre biobank for abdominal aortic aneurysms. BMJ Open. 2019 Aug 1;9(8):e028858. doi: 10.1136/bmjopen-2018-028858.
- Individual participant dataSharing planned: Yes. Researchers can initiate the procedure to request IPD for research that falls within the scientific scope of the biobank Pearl AAA.
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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.
Ron Balm, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm, Ruptured, run by Ron Balm at 2 sites in Netherlands.
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 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
AAA growth (time frame: Up to 10 years of follow-up). The study lists 7 primary outcomes in all. 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 NCT03320408, which also lists 1 linked publication.
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 22 Aug 2023.