MedDataX Logo

Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.

NCT ID: NCT02467062

Last Updated: 2016-12-06

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-09-30

Brief Summary

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

The aim of the investigator is to implement 4D FLOW MRI technique into a clinical setting and evaluate the blood flow pattern and wall sheer stress in patients with aortic and/or aortic valve diseases.

Detailed Description

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

Currently, the timing of the replacement of the ascending aorta is solely based on the aortic diameter and concomitant valvular dysfunction and the most recent ESC guideline proposes surgical intervention of ascending aortic aneurysm in patients who have a maximal aortic diameter ≥ 55mm, regardless of etiology. On the contrary, a recent publication by Rylski et al showed that most of the dissections occur at diameters smaller than 55 mm. Several publictions have shown that the flow profile and wall sheer stress derived from 4D flow MRI are significantly different between the valve morphology, the type of the aneurysm (tubular or diffuse enlargement) and pre and postoperative patients. Clinical implementation of 4D flow may enable us to stratify the patients with aortic and/or aortic valve diseases, especially in regard to the risk of ruptures. The patients with aortic/aortic valve disease will be referred to 4D flow MRI and contrast-enhanced angiografie from the aorta clinic. Phase 1: 6 healty adult volunteers will be scanned prior to the scan of the patients and settings would be optimised for 4D flow MRI and the contrast will not be given.

Phase 2: 30 patients either scheduled for surgical treatment of their aortic disease, post-operative patients and patients under surveillance for known aortic root and/or aortic valve disease will be imaged. Only patients having a clinical indication for an MRI of the aorta/aortic valve will be included.

Conditions

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

Aortic Valve Disease Aortic Aneurysm

Keywords

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

4D flow

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

4Dflow MRI parallel imaging

4D flow MRI with conventional parallel imaging

Group Type ACTIVE_COMPARATOR

MRI

Intervention Type DEVICE

MRI measurement to evualuate for 4D blood flow pattern

4D flow ktARC parallel imaging

4D flow MRI kt ARC spatiotemporal parallel imaging

Group Type OTHER

MRI

Intervention Type DEVICE

MRI measurement to evualuate for 4D blood flow pattern

Interventions

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

MRI

MRI measurement to evualuate for 4D blood flow pattern

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

\- Patients with aortic aneurysm and/or aortic valve disease older than 18 years.

Exclusion Criteria

* Patients \<18 years
* Pregnancy.
* Patients who have known contraindiction of MRI (ex claustrophobia, ICD, insulin pump etc)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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

Veerle Van Mossevelde

Data Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kaoru Tanaka, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Universitair Ziekenhuis Brussel

Jan Nijs, MD

Role: PRINCIPAL_INVESTIGATOR

Brussels Center for Aortic and Cardiovascular Connective Tissue Disease

Locations

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

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, Belgium

Site Status

Countries

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

Belgium

Other Identifiers

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

4D AORTIC FLOW MRI

Identifier Type: -

Identifier Source: org_study_id