MedDataX Logo

In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance

NCT ID: NCT03172390

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2020-03-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Rupture

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ascending aorta aneurysm Aortic wall shear stress 4D phase contrast Cardiovascular Magnetic Resonance Aortic dissection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective cohort
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort of patients : ascending aorta dilatation

measure of ascending aorta quality and quantity parameters by 4D Cardiac magnetic resonance

Group Type EXPERIMENTAL

4D Cardiac Magnetic Resonance

Intervention Type DEVICE

4D Cardiac Magnetic Resonance for patients with a ascending aorta dilatation without current indication for surgery for measured parameters of ascending aorta

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU de Saint-Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-A00871-52

Identifier Type: OTHER

Identifier Source: secondary_id

1708028

Identifier Type: -

Identifier Source: org_study_id