Vascular DiseasesNCT03669380
Superior Mesenteric Artery Dissection
An observational study of Vascular Diseases, run by Tongji Hospital at 1 site in China.
Trial summary
This study investigate CT images of patients with spontaneous isolated superior mesenteric artery dissection (SISMAD). The investigators also further analyze the CT morphological differences between different options, aiming to determine "alarming CT character" during initial conservative treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Diseases
- Type of treatment
- Injection or infusion
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2018to 26 Apr 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Between Oct. 2011 and Jan. 2018, a total of 57 consecutive patients with SISMAD were included in this study.
Who may be able to join
- SMA dissection
Who cannot join
- SMA dissection combined with aortic or other visceral arteries
- Trauma related SMA dissection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isolated Superior Mesenteric Artery Dissection With Concomitant Vascular Aberrancy: Extremely Rare Cases and Clinical Implications
This study investigate CT images of patients with spontaneous isolated superior mesenteric artery dissection (SISMAD). The investigators also further analyze the CT morphological differences between different options, aiming to determine "alarming CT character" during initial conservative treatment.
Read the detailed description
57 Patients with SISMAD from Oct 2011 to Jan 2018 in investigator's hospital were included in this research. The investigators collected relevant clinical data and further investigated the CTA characters of both true lumen and false lumen. SMA angle, distance between entry site of dissection and SMA root were also measured.
- Conditions
- Vascular Diseases
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| conservative treatment | Conservative treatment consisted of bowel rest, intravenous fluid therapy, nutritional support, strict blood pressure control, anticoagulation (with or without antiplatelet) and close observation | |
| Interventional and surgical treatment | Interventional and surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameters of true lumen
Measure the diameters of patent true lumen in patients with isolated mesenteric artery dissection
thrombosis in the false lumen , the distance between entry site of dissection and SMA root (P=0.133), the presence of SMA branch involving (P=0.322) have no difference in different treatment groups
Measured: up to 6 months
the distance between dissection and SMA root
Measure the distance between dissection and SMA root in patients with isolated mesenteric artery dissection
Measured: up to 6 months
the angle between SMA root and abodominal aorta
Measure the angle between SMA root and abodominal aorta in patients with isolated mesenteric artery dissection
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Jan 2018
- Primary completion10 Apr 2018
- Study completion26 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Dou, Tongji Hospital
- Investigators
- Lei Dou, Dr., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669380
- Sponsor's protocol ID
- TJ-207101
- Status last verified
- Sep 2018
- First submitted
- 12 May 2018
- Last updated
- 13 Sep 2018
- 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 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Superior Mesenteric Artery Dissection With Concomitant Vascular Aberrancy: Extremely Rare Cases and Clinical Implications
- ClinicalTrials.gov ID
- NCT03669380
- Acronym / sponsor ID
- TJ-207101
- Conditions
- Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 26 Apr 2018 (actual)
- First posted
- 13 Sep 2018 (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.
This study investigate CT images of patients with spontaneous isolated superior mesenteric artery dissection (SISMAD). The investigators also further analyze the CT morphological differences between different options, aiming to determine "alarming CT character" during initial conservative treatment.
Detailed description
57 Patients with SISMAD from Oct 2011 to Jan 2018 in investigator's hospital were included in this research. The investigators collected relevant clinical data and further investigated the CTA characters of both true lumen and false lumen. SMA angle, distance between entry site of dissection and SMA root were also measured.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative treatment | – | –Conservative treatment consisted of bowel rest, intravenous fluid therapy, nutritional support, strict blood pressure control, anticoagulation (with or without antiplatelet) and close observation |
| Interventional and surgical treatment | – | –Interventional and surgical treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between Oct. 2011 and Jan. 2018, a total of 57 consecutive patients with SISMAD were included in this study.
Key inclusion criteria (1 listed)
- SMA dissection
Key exclusion criteria (2 listed)
- SMA dissection combined with aortic or other visceral arteries
- Trauma related SMA 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 |
|---|---|---|
| Other | Interventional and surgical treatment |
Primary outcome
Diameters of true lumen
Time frame: up to 6 months
Measure the diameters of patent true lumen in patients with isolated mesenteric artery dissection thrombosis in the false lumen , the distance between entry site of dissection and SMA root (P=0.133), the presence of SMA branch involving (P=0.322) have no difference in different treatment groups
the distance between dissection and SMA root
Time frame: up to 6 months
Measure the distance between dissection and SMA root in patients with isolated mesenteric artery dissection
the angle between SMA root and abodominal aorta
Time frame: up to 6 months
Measure the angle between SMA root and abodominal aorta in patients with isolated mesenteric artery dissection
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 13 Sep 2018.
- 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.
Lei Dou, Dr. principal investigator
Tongji Hospital
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 Vascular Diseases, run by Tongji Hospital 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 1 inclusion and 2 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 13 Sep 2018. 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?
Diameters of true lumen (time frame: up to 6 months). The study lists 3 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 13 Sep 2018.