Abdominal Aortic AneurysmFAMRINCT00587977
Aortic Distensibility
An observational study of Abdominal Aortic Aneurysm, run by Mayo Clinic at 1 site in United States.
Trial summary
Can software be developed to automatically aid in the measurement of abdominal aortic aneurysms, and is there a way to predict future rupture or growth of abdominal aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jul 2009
- 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: Patients undergoing imaging of their abdominal aortic aneurysm
Who may be able to join
- AAA must be at least 3 cm to a maximum 4.9cm cross-sectional diameter.
- BMI 31 or less.
- Creatinine results <2.0 and within six months prior to scan.
- US patients must have only normal creatinine (0.9 to 1.4) for one year before study visit.
- Patients who are originally scheduled for US, who are then subsequently rolled in this study, will have only a ultrasound scan as followup after the initial CTA.
Who cannot join
- Creatinine > 2.0.
- Creatinine <0.9 or >1.4 for those who are scheduled for US.
- Atrial fibrillation or other arrythmia.
- Known AAA greater than 5 cm in size.
- Allergy to contrast dye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ECG-Gated Multidetector CT of Aortic Distensibility FAMRI
Can software be developed to automatically aid in the measurement of abdominal aortic aneurysms, and is there a way to predict future rupture or growth of abdominal aortic aneurysms.
Read the detailed description
Hypothesis: ECG-gated multidetector CT and ECG-gated Dual Source CT can be used to create multiple volumetric datasets of the abdominal aorta over the time period of the cardiac cycle, allowing for direct and regional calculations of abdominal aortic distensibility over the entire volume of the abdominal aorta, providing insight into risk of abdominal aortic aneurysm rupture and early large vessel stiffness.
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal aortic aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
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 |
|---|---|---|
| 1 | Aortic aneurysm repair | |
| 2 | Aortic aneurysm growth | |
| 3 | Aortic aneurysm growth stable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In year one, this data will be used to develop pulsatility software and test robustness.
Measured: First Year
Secondary outcomes (1)
In year two, the time-resolved CT angiographic datasets from each patient will be analyzed to determine peak AAA pulsatility and peak AAA relative pulsatility (to cross-sectional area within the aneurysm).
Measured: Year Two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startNov 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
- Investigators
- Joel G. Fletcher, M.D., Principal investigator, Mayo Clinic - Rochester, Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587977
- Sponsor's protocol ID
- 1994-04
- Other IDs
- 2A3360, FAMRI 2
- Acronym
- FAMRI
- Status last verified
- Nov 2012
- First submitted
- 22 Dec 2007
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang J, Fletcher JG, Vrtiska TJ, Manduca A, Thompson JL, Raghavan ML, Wentz RJ, McCollough CH. Large-vessel distensibility measurement with electrocardiographically gated multidetector CT: phantom study and initial experience. Radiology. 2007 Oct;245(1):258-66. doi: 10.1148/radiol.2451060530.
PubMed 17885194Wentz RJ, Manduca A, Fletcher JG, Siddiki HA, Shields RC, Vrtiska TJ, Spencer GC, Primak AN, Zhang J, Nielson TA, McCollough CH, Yu L. SPIE Medical Imaging 2007.: Physiology, Function, and Structure from Medical Images, 2007; 6511:1-9
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG-Gated Multidetector CT of Aortic Distensibility FAMRI
- ClinicalTrials.gov ID
- NCT00587977
- Acronym / sponsor ID
- FAMRI / 1994-04
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal aortic aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Flight Attendant Medical Research Institute
- Study start
- Nov 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Jan 2008 (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.
Can software be developed to automatically aid in the measurement of abdominal aortic aneurysms, and is there a way to predict future rupture or growth of abdominal aortic aneurysms.
Detailed description
Hypothesis: ECG-gated multidetector CT and ECG-gated Dual Source CT can be used to create multiple volumetric datasets of the abdominal aorta over the time period of the cardiac cycle, allowing for direct and regional calculations of abdominal aortic distensibility over the entire volume of the abdominal aorta, providing insight into risk of abdominal aortic aneurysm rupture and early large vessel stiffness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Aortic aneurysm repair |
| 2 | – | –Aortic aneurysm growth |
| 3 | – | –Aortic aneurysm growth stable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing imaging of their abdominal aortic aneurysm
Key inclusion criteria (5 listed)
- AAA must be at least 3 cm to a maximum 4.9cm cross-sectional diameter.
- BMI 31 or less.
- Creatinine results <2.0 and within six months prior to scan.
- US patients must have only normal creatinine (0.9 to 1.4) for one year before study visit.
- Patients who are originally scheduled for US, who are then subsequently rolled in this study, will have only a ultrasound scan as followup after the initial CTA.
Key exclusion criteria (5 listed)
- Creatinine > 2.0.
- Creatinine <0.9 or >1.4 for those who are scheduled for US.
- Atrial fibrillation or other arrythmia.
- Known AAA greater than 5 cm in size.
- Allergy to contrast dye.
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
In year one, this data will be used to develop pulsatility software and test robustness.
Time frame: First Year
1 secondary outcome
In year two, the time-resolved CT angiographic datasets from each patient will be analyzed to determine peak AAA pulsatility and peak AAA relative pulsatility (to cross-sectional area within the aneurysm).
Time frame: Year Two
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 9 Nov 2012.
- Background: PubMed 17885194Zhang J, Fletcher JG, Vrtiska TJ, Manduca A, Thompson JL, Raghavan ML, Wentz RJ, McCollough CH. Large-vessel distensibility measurement with electrocardiographically gated multidetector CT: phantom study and initial experience. Radiology. 2007 Oct;245(1):258-66. doi: 10.1148/radiol.2451060530.
- BackgroundWentz RJ, Manduca A, Fletcher JG, Siddiki HA, Shields RC, Vrtiska TJ, Spencer GC, Primak AN, Zhang J, Nielson TA, McCollough CH, Yu L. SPIE Medical Imaging 2007.: Physiology, Function, and Structure from Medical Images, 2007; 6511:1-9
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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.
Joel G. Fletcher, M.D. principal investigator
Mayo Clinic - Rochester, Minnesota
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 Abdominal Aortic Aneurysm, run by Mayo Clinic at 1 site in United States.
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 5 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 9 Nov 2012. 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 United States. 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?
In year one, this data will be used to develop pulsatility software and test robustness. (time frame: First Year). 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 NCT00587977, which also lists 2 linked publications.
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 9 Nov 2012.