- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03172390
In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance
November 12, 2020 updated by: Centre Hospitalier Universitaire de Saint Etienne
Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture.
There is substantial variation in individual aneurysm progression: established risk factors for an accelerated aneurysm growth rate include initial size or localization, the presence of aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Although there is an increased lifetime risk when the aortic diameter exceeds 6 cm, predicting aneurysm progression is nearly impossible and dissection and rupture also occur at diameters under 6 cm.
The assessment of aortic hemodynamics and the presence of altered flow patterns, as well as distribution and changes in wall shear stress (WSS) and the oscillatory shear index (OSI), using 4D phase contrast cardiovascular magnetic resonance (CMR) may provide further insights in how aneurysms develop and in assessing the risk of dissection.
The purpose of this study was to investigate in patients with dilated ascending aorta the flow patterns and vessel wall parameters in order to correlate these hemodynamics factors with changes in aorta size.
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
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
-
-
Loire
-
Saint-Étienne, Loire, France, 42055
- Chu de Saint-Etienne
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Supra-coronary aortic diameter measured by CT-scan or transthoracic/trans-esophageal echocardiography between 40 and 45 mm in case of presence of aortic valve disease, bicuspid aortic valve or connective tissue disease and between 40 and 50 mm in case of absence of aortic valve disease, bicuspid aortic valve disease or connective tissue.
- Informed consent for participation in the study
Exclusion Criteria:
- Contraindication to MRI
- Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.
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
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Cohort of patients : ascending aorta dilatation
measure of ascending aorta quality and quantity parameters by 4D Cardiac magnetic resonance
|
4D Cardiac Magnetic Resonance for patients with a ascending aorta dilatation without current indication for surgery for measured parameters of ascending aorta
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta
Time Frame: From baseline to 1 year
|
Aorta diameter [mm] is assessed by 4D phase contrast cardiovascular magnetic resonance (CMR) Wall shear stress (WSS) in aorta [Pa] is assessed by 4D phase contrast cardiovascular magnetic resonance (CMR).
|
From baseline to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aorta parameters associated with change in aorta diameter
Time Frame: From baseline to 1 year
|
Aorta parameters are a composite outcome :
|
From baseline to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 11, 2017
Primary Completion (ACTUAL)
April 11, 2019
Study Completion (ACTUAL)
March 4, 2020
Study Registration Dates
First Submitted
May 23, 2017
First Submitted That Met QC Criteria
May 29, 2017
First Posted (ACTUAL)
June 1, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 13, 2020
Last Update Submitted That Met QC Criteria
November 12, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1708028
- 2017-A00871-52 (OTHER: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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