Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02467062
Other study ID # 4D AORTIC FLOW MRI
Secondary ID
Status Completed
Phase N/A
First received June 2, 2015
Last updated December 5, 2016
Start date September 2015
Est. completion date September 2016

Study information

Verified date December 2016
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Device:
MRI
MRI measurement to evualuate for 4D blood flow pattern

Locations

Country Name City State
Belgium Universitair Ziekenhuis Brussel Jette Vlaams Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary the bloodflow pattern 1 day Yes
Secondary wall sheer stress 1 day Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Recruiting NCT06001489 - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy N/A
Not yet recruiting NCT04430972 - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Terminated NCT02128841 - Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve. Phase 2
Active, not recruiting NCT01194362 - A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
Not yet recruiting NCT05975567 - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Recruiting NCT06025149 - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed NCT05082337 - The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures N/A
Completed NCT05193760 - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Not yet recruiting NCT05941455 - A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve N/A
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Active, not recruiting NCT03924661 - SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Completed NCT04073875 - 18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis
Recruiting NCT03121053 - Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement Phase 4
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Completed NCT02688153 - EDWARDS INTUITY Valve System CADENCE Study N/A
Completed NCT02981004 - PAR I - Patient-to-Annulus Relation I
Recruiting NCT06126367 - Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease
Active, not recruiting NCT05082454 - Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)