NCT03669380

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

May 12, 2018

Last Update Submit

September 11, 2018

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    up to 6 months

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between Oct. 2011 and Jan. 2018, a total of 57 consecutive patients with SISMAD were included in this study.

You may qualify if:

  • SMA dissection

You may not qualify if:

  • SMA dissection combined with aortic or other visceral arteries
  • Trauma related SMA dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Lei Dou, Dr.

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 12, 2018

First Posted

September 13, 2018

Study Start

January 10, 2018

Primary Completion

April 10, 2018

Study Completion

April 26, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)