- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02722889
Aortic Elongation and Dissection
March 20, 2017 updated by: Maastricht University Medical Center
Ascending Aortic Length in Relation to Age and the Occurrence of Type A Aortic Dissection
Aim of this study is to measure length of the ascending aorta in adults and to investigate the clinical implication of 'elongation' of the aorta.
Study Overview
Status
Completed
Conditions
Detailed Description
Regarding to aortic geometry, attention is often drawn to aortic diameters since an increase in these diameters (e.g.
aneurysm) can lead to life-threatening complications such as dissection and/or rupture.
In daily practice however (e.g.
imaging reports), the investigators often encounter patients with elongation of the ascending aorta.
Little is known about the length of the proximal aorta.
Furthermore, the clinical implications of an elongated aorta are unknown.
Study Type
Observational
Enrollment (Actual)
298
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
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6202AZ
- Maastricht University Medical Center
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Reference group to assess 'normal' aortic length.
Description
Inclusion Criteria:
- Underwent recent (<6 years) contrast-enhanced CT scan which allows for segmentation and assessment of aortic geometry.
Exclusion Criteria:
- Age <18 years old.
- Prior thoracic, cardiac or aortic surgery.
- Genetic disease with cardiac and/or aortic involvement (e.g. Marfan's disease).
- Infectious disease of the aorta.
- Malignant disease with involvement of heart and/or aorta.
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 |
---|
Healthy controls
Healthy control patients
|
Type A dissection
Patients with proven type A dissection,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of the ascending aorta
Time Frame: Up to 72 months
|
Ascending aortic length as measured on computed tomography.
|
Up to 72 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joachim Wildberger, MD, PhD, Head of department of Radiology
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)
March 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
March 7, 2016
First Submitted That Met QC Criteria
March 23, 2016
First Posted (Estimate)
March 30, 2016
Study Record Updates
Last Update Posted (Actual)
March 22, 2017
Last Update Submitted That Met QC Criteria
March 20, 2017
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 16-4-027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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