Thoracic AortaNCT02722889
Aortic Elongation and Dissection
An observational study of Thoracic Aorta, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Aim of this study is to measure length of the ascending aorta in adults and to investigate the clinical implication of 'elongation' of the aorta. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Aorta
- How many people
- 298 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2016to Jan 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Reference group to assess 'normal' aortic length.
Who may be able to join
- Underwent recent (<6 years) contrast-enhanced CT scan which allows for segmentation and assessment of aortic geometry.
Who cannot join
- Age <18 years old.
- Prior thoracic, cardiac or aortic surgery.
- Genetic disease with cardiac and/or aortic involvement (e.g. Marfan's disease).
- Infectious disease of the aorta.
- Malignant disease with involvement of heart and/or aorta.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202AZ
About this study
Official title: Ascending Aortic Length in Relation to Age and the Occurrence of Type A Aortic Dissection
Aim of this study is to measure length of the ascending aorta in adults and to investigate the clinical implication of 'elongation' of the aorta.
Read the detailed description
Regarding to aortic geometry, attention is often drawn to aortic diameters since an increase in these diameters (e.g. aneurysm) can lead to life-threatening complications such as dissection and/or rupture. In daily practice however (e.g. imaging reports), the investigators often encounter patients with elongation of the ascending aorta. Little is known about the length of the proximal aorta. Furthermore, the clinical implications of an elongated aorta are unknown.
- Conditions
- Thoracic Aorta
- Keywords
- Ascending aorta, Elongation of the aorta, Type A dissection, Aortic rupture, Aortic length
- Medical subject headings
- Aortic Rupture
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 |
|---|---|---|
| Healthy controls | Healthy control patients | |
| Type A dissection | Patients with proven type A dissection, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of the ascending aorta
Ascending aortic length as measured on computed tomography.
Measured: Up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic AortaStudies 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
- Retrospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joachim Wildberger, MD, PhD, Principal investigator, Head of department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722889
- Sponsor's protocol ID
- 16-4-027
- Status last verified
- Mar 2016
- First submitted
- 7 Mar 2016
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascending Aortic Length in Relation to Age and the Occurrence of Type A Aortic Dissection
- ClinicalTrials.gov ID
- NCT02722889
- Acronym / sponsor ID
- 16-4-027
- Conditions
- Thoracic Aorta
- Keywords
- Ascending aorta, Elongation of the aorta, Type A dissection, Aortic rupture, Aortic length
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Mar 2016 (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.
Aim of this study is to measure length of the ascending aorta in adults and to investigate the clinical implication of 'elongation' of the aorta.
Detailed description
Regarding to aortic geometry, attention is often drawn to aortic diameters since an increase in these diameters (e.g. aneurysm) can lead to life-threatening complications such as dissection and/or rupture. In daily practice however (e.g. imaging reports), the investigators often encounter patients with elongation of the ascending aorta. Little is known about the length of the proximal aorta. Furthermore, the clinical implications of an elongated aorta are unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –Healthy control patients |
| Type A dissection | – | –Patients with proven type A dissection, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Reference group to assess 'normal' aortic length.
Key inclusion criteria (1 listed)
- Underwent recent (<6 years) contrast-enhanced CT scan which allows for segmentation and assessment of aortic geometry.
Key exclusion criteria (5 listed)
- Age <18 years old.
- Prior thoracic, cardiac or aortic surgery.
- Genetic disease with cardiac and/or aortic involvement (e.g. Marfan's disease).
- Infectious disease of the aorta.
- Malignant disease with involvement of heart and/or aorta.
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
Length of the ascending aorta
Time frame: Up to 72 months
Ascending aortic length as measured on computed tomography.
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 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Joachim Wildberger, MD, PhD principal investigator
Head of department of Radiology
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 Thoracic Aorta, run by Maastricht University Medical Center at 1 site 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 1 inclusion and 5 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 Mar 2017. 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 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?
Length of the ascending aorta (time frame: Up to 72 months). 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 22 Mar 2017.