- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669380
Superior Mesenteric Artery Dissection
September 11, 2018 updated by: Lei Dou, Tongji Hospital
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
57
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Between Oct. 2011 and Jan. 2018, a total of 57 consecutive patients with SISMAD were included in this study.
Description
Inclusion Criteria:
- SMA dissection
Exclusion Criteria:
- SMA dissection combined with aortic or other visceral arteries
- Trauma related SMA dissection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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
|
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Interventional and surgical treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
up to 6 months
|
|
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
|
up to 6 months
|
|
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
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lei Dou, Dr., Tongji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2018
Primary Completion (Actual)
April 10, 2018
Study Completion (Actual)
April 26, 2018
Study Registration Dates
First Submitted
May 12, 2018
First Submitted That Met QC Criteria
September 11, 2018
First Posted (Actual)
September 13, 2018
Study Record Updates
Last Update Posted (Actual)
September 13, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-207101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.