Ascendant Aortic AneurysmNCT03113539
Low-dose Gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
A study testing Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm in people with Ascendant Aortic Aneurysm, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
We will demonstrate the validity of measurements with a low-dose, EKG-gated CT without contrast in the ascending aorta evaluation, compared with the current Angio-CT measurements. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Ascendant Aortic Aneurysm
- What is being tested?
- Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCanada
- Study dates
- 12 Apr 2017to 30 May 2019
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years old and more
- 85 bpm or less
Who cannot join
- aortic material
- EKG gating not possible
- aorta pathology (thrombus, dissection)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-dose, EKG-gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
We will demonstrate the validity of measurements with a low-dose, EKG-gated CT without contrast in the ascending aorta evaluation, compared with the current Angio-CT measurements.
Read the detailed description
The actual protocol used in aorta evaluation consist of two CT-scans on the same study. The first scan that detects calcifications is using parameters with low-dose current, non EKG-gated and without contrast. The second scan uses iodine-contrast, EKG-gating and higher current dose to obtain higher image quality of diagnostic value.
The study will optimize the first scan parameters and compare the measures of the aorta diameters from the standard protocol.
By modifying the first scan parameters, we would demonstrate that the follow-up of an aortic aneurysm can safely be made with lower radiation exposure.
- Conditions
- Ascendant Aortic Aneurysm
- Being tested
- Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysmOther
On the same day, the subject will do :
- Modified low-dose, EKG-gated CT without contrast
- Usual high-dose, EKG-gated CT with contrast
Comparing aortic diameters from the two protocols.
| Study group | Role | What they receive |
|---|---|---|
| Subjects awaiting for an aortic evaluation | Experimental | Subjects already waiting for an aortic evaluation, either a first diagnostic scan or follow-up of a known aneurysm.
Each subjects will have the two CT-scans on the same day. Receives: Other: Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures validity (aorta diameter in mm from scan images)
Comparing aorta diameters from the two modalities.
Measured: 12 months
Secondary outcomes (1)
Radiation (in msev from scanner report)
Comparing radiation exposure with the two modalities
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start12 Apr 2017
- Primary completion30 Apr 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascendant Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Farand, Université de Sherbrooke
- Investigators
- Paul Farand, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113539
- Sponsor's protocol ID
- 2016-1074
- Status last verified
- Jul 2019
- First submitted
- 2 Apr 2017
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose, EKG-gated CT Validity for the Evaluation of Ascendant Aortic Aneurysm.
- ClinicalTrials.gov ID
- NCT03113539
- Acronym / sponsor ID
- 2016-1074
- Conditions
- Ascendant Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 13 Apr 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.
We will demonstrate the validity of measurements with a low-dose, EKG-gated CT without contrast in the ascending aorta evaluation, compared with the current Angio-CT measurements.
Detailed description
The actual protocol used in aorta evaluation consist of two CT-scans on the same study. The first scan that detects calcifications is using parameters with low-dose current, non EKG-gated and without contrast. The second scan uses iodine-contrast, EKG-gating and higher current dose to obtain higher image quality of diagnostic value.
The study will optimize the first scan parameters and compare the measures of the aorta diameters from the standard protocol.
By modifying the first scan parameters, we would demonstrate that the follow-up of an aortic aneurysm can safely be made with lower radiation exposure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects awaiting for an aortic evaluation | Experimental | Other: Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysmSubjects already waiting for an aortic evaluation, either a first diagnostic scan or follow-up of a known aneurysm. Each subjects will have the two CT-scans on the same day. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 years old and more
- 85 bpm or less
Key exclusion criteria (3 listed)
- aortic material
- EKG gating not possible
- aorta pathology (thrombus, dissection)
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 |
|---|---|---|
| Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysmOn the same day, the subject will do : 1. Modified low-dose, EKG-gated CT without contrast 2. Usual high-dose, EKG-gated CT with contrast Comparing aortic diameters from the two protocols. | Other | Subjects awaiting for an aortic evaluation |
Primary outcome
Measures validity (aorta diameter in mm from scan images)
Time frame: 12 months
Comparing aorta diameters from the two modalities.
1 secondary outcome
Radiation (in msev from scanner report)
Time frame: 12 months
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 18 Jul 2019.
- Individual participant dataSharing planned: No
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.
Paul Farand principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm in people with Ascendant Aortic Aneurysm, run by Université de Sherbrooke at 1 site in Canada.
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 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 18 Jul 2019. 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 Canada. 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?
Measures validity (aorta diameter in mm from scan images) (time frame: 12 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 18 Jul 2019; AzTrials last refreshed its copy on 6 Nov 2026.