NCT02602951

Brief Summary

The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the vascular anatomy. These sequences, widely used in clinical routine have shown their utility, in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences allow to quantify arterial parameters such as the speed of the circulating flow. By allowing an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the detection of vascular lesion and complete the exploration of the cervico-encephalic vascular pathologies by providing hemodynamical measures not yet accessible in clinical settings. In this context, the aim of the study is to evaluate the feasibility and the clinical usefulness of this 4D Flow technique to image brain vascular disorders including steno occlusive disorders. The evaluation will include several steps: 1/ optimization of acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for the post-processing 3/ feasibility for imaging of brain vascular disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

October 6, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

November 17, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

October 6, 2015

Last Update Submit

October 18, 2017

Conditions

Cerebro-vascular Disease

Outcome Measures

Primary Outcomes (1)

  • Number of patients presenting linear flow conditions assessed by the visual analysis of computed streamlines visualisation

    Flow tracking (clinical utility on the basis of qualitative criteria).

    through study completion, an average of 12 months

Secondary Outcomes (2)

  • Speed measurement (m/s) of velocitymeasured in the crossection of vessels.

    through study completion, an average of 12 months

  • Flow aliasing within the vessels.

    through study completion, an average of 12 months

Study Arms (2)

Control

EXPERIMENTAL

Pilot subjects

Other: Pilot MRI program

Patients

EXPERIMENTAL

Patients with an intracranial disorder or needing a supraaortic trunk MRA

Other: MRI with 4D Flow sequence

Interventions

Pilot MRI programOTHER

Pilot MRI program

Control
MRI with 4D Flow sequenceOTHER

MRI with 4D Flow sequence

Patients

Eligibility Criteria

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

You may qualify if:

  • Patients:
  • Patient of 18 years old and more
  • Patient reffered to the imaging department for a MRI for the exploration of a cervical or intracranial vascular disease (cervical stenosis, arterio-venous malformation)
  • Patient whose MRI requires an injection of gadolinium
  • Patient with insurance
  • Informed consent
  • Experimental subjects:
  • Absence of known cerebral or arterial pathology. Absence of MR contraindication
  • years old or more

You may not qualify if:

  • Emergency situation: patient in an urgent situation care
  • Contraindications to the administration of Gadolinium (patients only)
  • Contraindications to MRI :
  • cardiac or neuronal stimulating device, ferromagnetic surgical Clips, cochlear Implants, metallic intraocular Foreign bodies or in the nervous system
  • Claustrophobia
  • Pregnant Women
  • Subjects deprived of freedom by court order or administration staff
  • Major Subjects protected by the law
  • Known Renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Myriam EDJLALI, MD

    Centre Hospitalier Sainte-Anne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

November 11, 2015

Study Start

November 17, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

FR(1)