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

NCT03172390 | Completed

• 2 other identifiers: 17080282017-A00871-52
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Rupture

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation between wall shear stress (WSS) and aorta diameter in patient with dilated ascending aorta

  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 Outcomes (1)

• Aorta parameters associated with change in aorta diameter

  From baseline to 1 year

Study Arms (1)

Cohort of patients : ascending aorta dilatation

EXPERIMENTAL

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

Device: 4D Cardiac Magnetic Resonance

Interventions

4D Cardiac Magnetic Resonance DEVICE

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

Cohort of patients : ascending aorta dilatation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication to MRI
• Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France

Location

MeSH Terms

Conditions

Aortic Rupture; Aneurysm, Ascending Aorta; Aortic Dissection

Condition Hierarchy (Ancestors)

Aneurysm, Ruptured; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aortic Diseases; Rupture; Wounds and Injuries; Aortic Aneurysm, Thoracic; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 1, 2017
• Study Start: October 11, 2017
• Primary Completion: April 11, 2019
• Study Completion: March 4, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)