Aortomesenteric AngleNCT03937193
Normal Range of Superior Mesenteric Artery in Young Chinese Population and Its Correlation With Retroperitoneal Adipose Tissue
An observational study of Aortomesenteric Angle and Aortomesenteric Distance, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
In literature, superior mesenteric artery (SMA) angle, also named as aortomesenteric angle (AMA), varies greatly in both adult and children; while the aortomesenteric distance also ranges widely. Both AMA and AMD are influenced by retroperitoneal fat. Read more about this study
- Who is it for?
- Ages 10 to 35 years
- Conditions the study is for
- Aortomesenteric Angle, Aortomesenteric Distance, Retroperitoneal Adipose Tissue
- What is being tested?
- computerized tomography
- How many people
- 510 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2019to 30 Jun 2021
- 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 10 to 35 years
- All sexes
- Child, Adult
Study population: The investigators will retrospectively recruit individuals from the local population who had undergone abdomen contrast CT scans within hospitals in the New Territories East Cluster (NTEC) of Hong Kong for both emergency and elective purposes in the year 2013-2019. Total sample will comprise two groups: (1) Non-SMAS Group (N=500); and (2) SMAS group (N=10).
Who may be able to join
- With age range of 10-35 years old.
- Chinese ethnicity.
- With abdomen contrast CT.
Who cannot join
- Any patients with diagnosis of SMAS will be excluded from the Non-SMAS group.
- Patients who had undergone more than one CT scan during the research period.
- Previous retroperitoneal, abdominal surgery.
- Conditions causing significant weight loss, e.g. anorexia nervosa, malabsorption.
- Presence of abdominal masses or pathology that will affect the anatomy of aorta- superior mesenteric artery and the retroperitoneal structures.
- Presence of severe scoliosis and/or history of spinal fixation that may increase incidence of SMA syndrome.
- Presence of free intraperitoneal or retroperitoneal fluid that may affect fat measurement, e.g. following trauma, or ascites.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normal Range of Superior Mesenteric Artery on Computerized Tomography in Young Chinese Population and Its Correlation With Retroperitoneal Adipose Tissue
In literature, superior mesenteric artery (SMA) angle, also named as aortomesenteric angle (AMA), varies greatly in both adult and children; while the aortomesenteric distance also ranges widely. Both AMA and AMD are influenced by retroperitoneal fat. Decrease of AMA and AMD may lead to the superior mesenteric artery syndrome(SMAS), which is a rare medical condition mainly presenting with duodenum obstruction. To our knowledge, normal range of AMA and AMD in local young Chinese population remain unclear; on the other hand, there have only a few studies exploring the relationship between them. This project proposes to establish the normal range of AMA and AMD in local young Chinese population, and to further investigate how the retroperitoneal adipose tissue correlates with AMA and AMD. The normal range obtained in this proposed study will provide more specific reference value to distinguish abnormal AMA and AMD, and to improve the diagnosis accuracy of SMAS in local population. Moreover, this study will provide deeper insight concerning the impact of retroperitoneal fat on AMA and AMD.
- Being tested
- computerized tomography
- Keywords
- aortomesenteric angle, aortomesenteric distance, retroperitoneal adipose tissue, computerized tomography, young Chinese population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized tomographyDiagnostic test
abdomen contrast computerized tomography performed for both emergency and elective purposes in HK public hospitals.
| Study group | Role | What they receive |
|---|---|---|
| Non-SMAS group | subjects in this group are not clinically diagnosed as superior mesenteric artery syndrome(SMAS). Receives: Diagnostic Test: computerized tomography | |
| SMAS group | subjects in this group are clinically diagnosed as superior mesenteric artery syndrome(SMAS). Receives: Diagnostic Test: computerized tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
aortomesenteric angle (AMA)
aortomesenteric angle in degree measured on sagittal CT image
Measured: 2 years
aortomesenteric distance (AMD)
aortomesenteric distance in millimeter(mm) on axial CT image
Measured: 2 years
visceral fat area
visceral fat area in square centimeter(cm2) evaluated by image post-processing software
Measured: 2 years
subcutaneous fat area
subcutaneous fat area in square centimeter(cm2) evaluated by image post-processing software
Measured: 2 years
area ratio of visceral fat to subcutaneous fat
area ratio in percentage(%)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start25 Jul 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortomesenteric AngleStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- North District Hospital
- Responsible party
- Principal investigator, Professor Winnie W.C. Chu, Chinese University of Hong Kong
- Investigators
- Kai Ho Yam, MBChB, Principal investigator, Department of Radiology, North District Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937193
- Sponsor's protocol ID
- 2019.310
- Status last verified
- May 2022
- First submitted
- 2 May 2019
- Last updated
- 19 May 2022
- Results posted
- No
- 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 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Range of Superior Mesenteric Artery on Computerized Tomography in Young Chinese Population and Its Correlation With Retroperitoneal Adipose Tissue
- ClinicalTrials.gov ID
- NCT03937193
- Acronym / sponsor ID
- 2019.310
- Keywords
- aortomesenteric angle, aortomesenteric distance, retroperitoneal adipose tissue, computerized tomography, young Chinese population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- North District Hospital
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 3 May 2019 (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.
In literature, superior mesenteric artery (SMA) angle, also named as aortomesenteric angle (AMA), varies greatly in both adult and children; while the aortomesenteric distance also ranges widely. Both AMA and AMD are influenced by retroperitoneal fat. Decrease of AMA and AMD may lead to the superior mesenteric artery syndrome(SMAS), which is a rare medical condition mainly presenting with duodenum obstruction. To our knowledge, normal range of AMA and AMD in local young Chinese population remain unclear; on the other hand, there have only a few studies exploring the relationship between them. This project proposes to establish the normal range of AMA and AMD in local young Chinese population, and to further investigate how the retroperitoneal adipose tissue correlates with AMA and AMD. The normal range obtained in this proposed study will provide more specific reference value to distinguish abnormal AMA and AMD, and to improve the diagnosis accuracy of SMAS in local population. Moreover, this study will provide deeper insight concerning the impact of retroperitoneal fat on AMA and AMD.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-SMAS group | – | Diagnostic Test: computerized tomographysubjects in this group are not clinically diagnosed as superior mesenteric artery syndrome(SMAS). |
| SMAS group | – | Diagnostic Test: computerized tomographysubjects in this group are clinically diagnosed as superior mesenteric artery syndrome(SMAS). |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The investigators will retrospectively recruit individuals from the local population who had undergone abdomen contrast CT scans within hospitals in the New Territories East Cluster (NTEC) of Hong Kong for both emergency and elective purposes in the year 2013-2019. Total sample will comprise two groups: (1) Non-SMAS Group (N=500); and (2) SMAS group (N=10).
Key inclusion criteria (3 listed)
- With age range of 10-35 years old.
- Chinese ethnicity.
- With abdomen contrast CT.
Key exclusion criteria (7 listed)
- Any patients with diagnosis of SMAS will be excluded from the Non-SMAS group.
- Patients who had undergone more than one CT scan during the research period.
- Previous retroperitoneal, abdominal surgery.
- Conditions causing significant weight loss, e.g. anorexia nervosa, malabsorption.
- Presence of abdominal masses or pathology that will affect the anatomy of aorta- superior mesenteric artery and the retroperitoneal structures.
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 |
|---|---|---|
| computerized tomographyabdomen contrast computerized tomography performed for both emergency and elective purposes in HK public hospitals. | Diagnostic test | Non-SMAS group, SMAS group |
Primary outcome
aortomesenteric angle (AMA)
Time frame: 2 years
aortomesenteric angle in degree measured on sagittal CT image
aortomesenteric distance (AMD)
Time frame: 2 years
aortomesenteric distance in millimeter(mm) on axial CT image
visceral fat area
Time frame: 2 years
visceral fat area in square centimeter(cm2) evaluated by image post-processing software
subcutaneous fat area
Time frame: 2 years
subcutaneous fat area in square centimeter(cm2) evaluated by image post-processing software
area ratio of visceral fat to subcutaneous fat
Time frame: 2 years
area ratio in percentage(%)
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 19 May 2022.
- 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.
Kai Ho Yam, MBChB principal investigator
Department of Radiology, North District Hospital, Hong Kong
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 Aortomesenteric Angle and Aortomesenteric Distance, run by Chinese University of Hong Kong at 1 site in China.
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 7 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 19 May 2022. 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 China. 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?
aortomesenteric angle (AMA) (time frame: 2 years). The study lists 5 primary outcomes in all. 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 19 May 2022.