NCT02467062

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

June 2, 2015

Last Update Submit

December 5, 2016

Conditions

Aortic Valve DiseaseAortic Aneurysm

Keywords

4D flow

Outcome Measures

Primary Outcomes (1)

  • the bloodflow pattern

    1 day

Secondary Outcomes (1)

  • wall sheer stress

    1 day

Study Arms (2)

4Dflow MRI parallel imaging

ACTIVE COMPARATOR

4D flow MRI with conventional parallel imaging

Device: MRI

4D flow ktARC parallel imaging

OTHER

4D flow MRI kt ARC spatiotemporal parallel imaging

Device: MRI

Interventions

MRIDEVICE

MRI measurement to evualuate for 4D blood flow pattern

4D flow ktARC parallel imaging4Dflow MRI parallel imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Aneurysm

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesAneurysmVascular DiseasesAortic Diseases

Study Officials

  • Kaoru Tanaka, MD PhD

    Department of Radiology, Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Jan Nijs, MD

    Brussels Center for Aortic and Cardiovascular Connective Tissue Disease

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Data Nurse

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 9, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)