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Aortic Elongation and Dissection

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ClinicalTrials.gov Identifier: NCT02722889
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date March 7, 2016
First Posted Date March 30, 2016
Last Update Posted Date March 22, 2017
Actual Study Start Date March 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 23, 2016)
Length of the ascending aorta [ Time Frame: Up to 72 months ]
Ascending aortic length as measured on computed tomography.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Aortic Elongation and Dissection
Official Title Ascending Aortic Length in Relation to Age and the Occurrence of Type A Aortic Dissection
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Reference group to assess 'normal' aortic length.
Condition Thoracic Aorta
Intervention Not Provided
Study Groups/Cohorts
  • Healthy controls
    Healthy control patients
  • Type A dissection
    Patients with proven type A dissection,
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 20, 2017)
298
Original Estimated Enrollment
 (submitted: March 23, 2016)
1000
Actual Study Completion Date January 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02722889
Other Study ID Numbers 16-4-027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Joachim Wildberger, MD, PhD Head of department of Radiology
PRS Account Maastricht University Medical Center
Verification Date March 2016