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Superior Mesenteric Artery Dissection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669380
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Lei Dou, Tongji Hospital

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.

Condition or disease
Vascular Diseases

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.

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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Isolated Superior Mesenteric Artery Dissection With Concomitant Vascular Aberrancy: Extremely Rare Cases and Clinical Implications
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : April 10, 2018
Actual Study Completion Date : April 26, 2018

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
Interventional and surgical treatment



Primary Outcome Measures :
  1. 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


  2. 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

  3. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • SMA dissection

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669380


Locations
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China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Tongji Hospital
Investigators
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Principal Investigator: Lei Dou, Dr. Tongji Hospital
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Responsible Party: Lei Dou, principal investigator, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03669380    
Other Study ID Numbers: TJ-207101
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vascular Diseases
Aneurysm, Dissecting
Cardiovascular Diseases
Aneurysm