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

Status

Completed

Conditions

Intervention / 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 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

    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital

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
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

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.

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