Aortic Elongation and Dissection | NCT02722889

Studies
Aortic Elongation and Dissection

NCT02722889

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Mar 22, 2017Actual

Enrollment

298Actual

Phase

Not provided

Conditions

Thoracic Aorta

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Jan 2017Actual

First Submitted Date

Mar 7, 2016

First Submission Date that Met QC Criteria

Mar 23, 2016

First Posted Date

Mar 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2017

Last Update Posted Date

Mar 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

298Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy controls		Healthy control patients
Type A dissection		Patients with proven type A dissection,

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of the ascending aorta	Ascending aortic length as measured on computed tomography.	Up to 72 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Reference group to assess 'normal' aortic length.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Wildberger, MD, PhD	Head of department of Radiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center		Maastricht	Limburg	6202AZ	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001019	Aortic Rupture

Ancestor Terms

ID	Term
D017542	Aneurysm, Ruptured
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided