Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | March 30, 2016 |
| End Date: | June 30, 2019 |
| Contact: | Sara Eischen |
| Email: | surgcto@umn.edu |
| Phone: | 612-626-2498 |
The primary objective of this research project is development and validation of a new,
non-contrast gated aortic (NCGA) computer tomography scan algorithm for screening of aortic
aneurysm in the chest and abdomen in at risk patients. This study would initially be
performed in patients with a known aneurysm and done in addition to their indicated
surveillance CT scan.
non-contrast gated aortic (NCGA) computer tomography scan algorithm for screening of aortic
aneurysm in the chest and abdomen in at risk patients. This study would initially be
performed in patients with a known aneurysm and done in addition to their indicated
surveillance CT scan.
Study Design: Patients who agree to enroll in the study will get the NCGA study as well as a
routine non-contrast computed tomography of chest/abdomen/pelvis within one year following
recruitment at the patient's convenience. No follow-up will be required, but any clinically
relevant findings on the testing will be communicated to the PCP through EPIC in-basket.
Urgent findings, as determined by the primary investigator, will also result in a direct
communication with the PCP. It is expected that any such findings will also be seen on the
standard and clinically indicated CT which they are also undergoing, and so "new or unique"
findings on the study NCGA test are not expected to occur. The final study visit will be the
day of participation.
Study Design: Patients who agree to enroll in the study will get the NCGA study as well as a
routine non-contrast computed tomography of chest/abdomen/pelvis within one year following
recruitment at the patient's convenience. No follow-up will be required, but any clinically
relevant findings on the testing will be communicated to the PCP through EPIC in-basket.
Urgent findings, as determined by the primary investigator, will also result in a direct
communication with the PCP. It is expected that any such findings will also be seen on the
standard and clinically indicated CT which they are also undergoing, and so "new or unique"
findings on the study NCGA test are not expected to occur. The final study visit will be the
day of participation.
Study Procedures: One visit to complete one (1) non-contrast (no "dye"/contrast material will
be injected) computed tomography (CT) scan of the chest, abdomen and pelvis. This visit will
occur within one year following recruitment, scheduled at the patient's convenience. This one
visit represents the totality of study participation for each participant.
Study Duration: For each individual, participation is only over one day - the day of the
patient's non-contrast CT scan. No early termination visits or unscheduled visits apply.
The anticipated duration to complete enrollment of all participants is 1 year. Following
completion of the study, the study team is planning for an interim period of 6 months for
discussion and planning for future projects.
routine non-contrast computed tomography of chest/abdomen/pelvis within one year following
recruitment at the patient's convenience. No follow-up will be required, but any clinically
relevant findings on the testing will be communicated to the PCP through EPIC in-basket.
Urgent findings, as determined by the primary investigator, will also result in a direct
communication with the PCP. It is expected that any such findings will also be seen on the
standard and clinically indicated CT which they are also undergoing, and so "new or unique"
findings on the study NCGA test are not expected to occur. The final study visit will be the
day of participation.
Study Design: Patients who agree to enroll in the study will get the NCGA study as well as a
routine non-contrast computed tomography of chest/abdomen/pelvis within one year following
recruitment at the patient's convenience. No follow-up will be required, but any clinically
relevant findings on the testing will be communicated to the PCP through EPIC in-basket.
Urgent findings, as determined by the primary investigator, will also result in a direct
communication with the PCP. It is expected that any such findings will also be seen on the
standard and clinically indicated CT which they are also undergoing, and so "new or unique"
findings on the study NCGA test are not expected to occur. The final study visit will be the
day of participation.
Study Procedures: One visit to complete one (1) non-contrast (no "dye"/contrast material will
be injected) computed tomography (CT) scan of the chest, abdomen and pelvis. This visit will
occur within one year following recruitment, scheduled at the patient's convenience. This one
visit represents the totality of study participation for each participant.
Study Duration: For each individual, participation is only over one day - the day of the
patient's non-contrast CT scan. No early termination visits or unscheduled visits apply.
The anticipated duration to complete enrollment of all participants is 1 year. Following
completion of the study, the study team is planning for an interim period of 6 months for
discussion and planning for future projects.
Inclusion Criteria:
- Adult patients who carry the diagnosis of thoracic aortic aneurysm, aortic dissection,
or abdominal aortic aneurysm and require CT imaging to evaluate the pathology
Exclusion Criteria:
- Current pregnancy
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