- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04785105
Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis.
March 4, 2021 updated by: Hospices Civils de Lyon
Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis Depends on Celiac and Inferior Mesenteric Arteries Status.
The aim of this study was to evaluate asymptomatic superior mesenteric artery (SMA) stenosis prognosis according to the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.
Study Overview
Detailed Description
BACKGROUND: The benefit of preventive treatment for SMA stenosis remains uncertain.
The latest guidelines remain unclear given the lack of data in the literature.
Study Type
Observational
Enrollment (Actual)
77
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
-
-
-
Bron, France, 69500
- Groupement Hospitalier Est
-
-
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
- patients with isolated >70% SMA stenosis
- patients with both SMA stenosis and CA or/and IMA >70% stenosis
Description
Inclusion Criteria:
- the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.
Exclusion Criteria:
-
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patient with isolated SMA stenosis
patient with isolated SMA stenosis on initial scanner
|
No intervention
|
patient with both SMA stenosis and CA or/and IMA stenosis
patient with both SMA stenosis and CA or/and IMA stenosis on initial scanner
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of mesenteric disease defined as acute mesenteric ischemia or chronic mesenteric ischemia.
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 1, 2017
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
June 22, 2020
First Submitted That Met QC Criteria
March 4, 2021
First Posted (Actual)
March 5, 2021
Study Record Updates
Last Update Posted (Actual)
March 5, 2021
Last Update Submitted That Met QC Criteria
March 4, 2021
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMA_2020
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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