NCT03986645

Brief Summary

Assess the accuracy of 4D flow cardiac MRI to measure blood flow and velocity, delineate 3D cardiac anatomy and visualize flow dynamics using two (2) different pulse sequences.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

October 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

May 8, 2019

Last Update Submit

June 12, 2019

Conditions

Indication, Unlabeled

Keywords

4DFlow

Outcome Measures

Primary Outcomes (1)

  • Feasibility of data processing

    Comparison of flow velocities and blood flow measured by 4D flow cMRI pulse sequences against phantom corrected 2D cMRI data.

    Within 72 hours after completion of exam

Secondary Outcomes (3)

  • Image quality

    Within 72 hours after completion of exam

  • Comparability

    Within 72 hours after completion of exam

  • Clinical value

    Within 72 hours after completion of exam

Study Arms (1)

4DFLOW

EXPERIMENTAL

Acquire MR 4DFLow data.

Device: MR data acquisition

Interventions

MR data acquisitionDEVICE

MR data acquisition using CE and non-CE marked pulse sequences.

4DFLOW

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical referral for cMRI in the absence of any contraindication to cMRI
  • Flow measurements are part of the clinical cMRI protocol
  • Signed informed consent of participants and/or legal representatives according to current ethical rules and regulations for children and adults

You may not qualify if:

  • Any contraindication for undergoing a cMRI examination or for receiving gadolinium contrast media (renal failure, allergy) per internal institutional policy of University Children's Hospital Zurich
  • Any intrathoracic device causing imaging artifacts
  • Medical condition at time of examination that would make additional study-related MR scans an unjustified burden or risk.
  • Inability or unwillingness to provide informed consent.
  • Absence of any contraindication to cMRI
  • Signed informed consent of participants according to current ethical rules and regulations
  • \- Any contraindication for undergoing a cMRI examination per internal institutional policy of University Children's Hospital Zurich

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Emanuela Valsangiacomo, Prof. MD

    UChilldrenZurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Prospective, exploratory, non-randomized, interventional study without control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 8, 2019

First Posted

June 14, 2019

Study Start

October 1, 2016

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

June 14, 2019

Record last verified: 2019-06