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出境医 / 临床实验 / Clinical Evaluation of 4D Flow Cardiac MRI Sequences (Eval-4DFlow)

Clinical Evaluation of 4D Flow Cardiac MRI Sequences (Eval-4DFlow)

Study Description
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.

Condition or disease Intervention/treatment Phase
Indication, Unlabeled Device: MR data acquisition Not Applicable

Detailed Description:

Advances in pediatric (cardiac) surgery, interventional techniques and medical care have improved survival for children born with congenital heart disease. Assessment of blood flow and pressures within the heart plays an integral role in the management of patients with congenital or acquired structural heart disease aiding with diagnoses, surveillance for complications, in relation to surgical or catheter procedures, and for therapeutic decision making. Current gold standard, direct intracardiac measurement of flow and pressures is an invasive procedure, while non-invasive echography-Doppler is limited by poor acoustic windows and operator dependency.

Therefore, cardiac MRI (cMRI) has been recommended as an important alternative in imaging of pediatric heart disease. Current clinical standard for MR flow imaging is 2-dimensional providing flow in a single cross-sectional plane. Current clinical CMR protocols in pediatric congenital heart disease are time consuming, depend on technician's experience and require direct supervision by an experienced cardiovascular imaging specialist. 4D Flow is a new approach for cMRI that might overcome these disadvantages. It allows scanning of the entire chest in approximately 7 minutes (depending on field of view, heart rate and resolution). The images can be off-line reconstructed in any plane, avoiding the need to precisely define crosssectional planes during acquisition for each vessel. Owing to time resolved visualizations of intracardiac flow dynamics occult jets or dynamic jets might be more likely to be detected. Potential disadvantages, rsp. potential advantages to be confirmed include lower temporal resolution of 4D sequences than current 2D sequences, unknown consequences of gradient artefacts induced by new velocity encoding schemes and diagnostic plausibility of disease related image features .

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, exploratory, non-randomized, interventional study without control group.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Evaluation of 4D Flow Cardiac MRI Sequences - A Prospective Exploratory Study
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: 4DFLOW
Acquire MR 4DFLow data.
 Device: MR data acquisition
MR data acquisition using CE and non-CE marked pulse sequences.
Outcome Measures
Primary Outcome Measures :
  1. Feasibility of data processing [ Time Frame: Within 72 hours after completion of exam ]
    Comparison of flow velocities and blood flow measured by 4D flow cMRI pulse sequences against phantom corrected 2D cMRI data.


Secondary Outcome Measures :
  1. Image quality [ Time Frame: Within 72 hours after completion of exam ]
    Qualitative grading of 4D flow cMRI anatomical images for image quality using a numerical scale.

  2. Comparability [ Time Frame: Within 72 hours after completion of exam ]
    Qualitative grading of comparability of anatomical findings in 4D flow cMRI anatomical images with contrast-enhanced MR angiography images, if these have been acquired during the clinical examination of patients, using a numerical scale.

  3. Clinical value [ Time Frame: Within 72 hours after completion of exam ]
    Qualitative grading of clinical and diagnostic value of visualizations of flow dynamics using a numerical scale.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria Patients:

  • 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
  • For females in reproductive age, exclusion of pregnancy by a pregnancy test conducted before the cMRI

Exclusion Criteria Patients:

  • 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.

Inclusion Criteria Healthy Controls:

  • Absence of any contraindication to cMRI
  • Signed informed consent of participants according to current ethical rules and regulations
  • For females in reproductive age, exclusion of pregnancy by a pregnancy test conducted before the cMRI.

Exclusion Criteria Healthy Controls:

- Any contraindication for undergoing a cMRI examination per internal institutional policy of University Children's Hospital Zurich

Contacts and Locations

Sponsors and Collaborators
Emanuela Valsangiacomo
Investigators
Layout table for investigator information
Principal Investigator: Emanuela Valsangiacomo, Prof. MD UChilldrenZurich
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date June 14, 2019
Actual Study Start Date  ICMJE October 1, 2016
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019) 		Feasibility of data processing [ Time Frame: Within 72 hours after completion of exam ]
Comparison of flow velocities and blood flow measured by 4D flow cMRI pulse sequences against phantom corrected 2D cMRI data.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Image quality [ Time Frame: Within 72 hours after completion of exam ]
    Qualitative grading of 4D flow cMRI anatomical images for image quality using a numerical scale.
  • Comparability [ Time Frame: Within 72 hours after completion of exam ]
    Qualitative grading of comparability of anatomical findings in 4D flow cMRI anatomical images with contrast-enhanced MR angiography images, if these have been acquired during the clinical examination of patients, using a numerical scale.
  • Clinical value [ Time Frame: Within 72 hours after completion of exam ]
    Qualitative grading of clinical and diagnostic value of visualizations of flow dynamics using a numerical scale.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of 4D Flow Cardiac MRI Sequences
Official Title  ICMJE Clinical Evaluation of 4D Flow Cardiac MRI Sequences - A Prospective Exploratory Study
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.
Detailed Description

Advances in pediatric (cardiac) surgery, interventional techniques and medical care have improved survival for children born with congenital heart disease. Assessment of blood flow and pressures within the heart plays an integral role in the management of patients with congenital or acquired structural heart disease aiding with diagnoses, surveillance for complications, in relation to surgical or catheter procedures, and for therapeutic decision making. Current gold standard, direct intracardiac measurement of flow and pressures is an invasive procedure, while non-invasive echography-Doppler is limited by poor acoustic windows and operator dependency.

Therefore, cardiac MRI (cMRI) has been recommended as an important alternative in imaging of pediatric heart disease. Current clinical standard for MR flow imaging is 2-dimensional providing flow in a single cross-sectional plane. Current clinical CMR protocols in pediatric congenital heart disease are time consuming, depend on technician's experience and require direct supervision by an experienced cardiovascular imaging specialist. 4D Flow is a new approach for cMRI that might overcome these disadvantages. It allows scanning of the entire chest in approximately 7 minutes (depending on field of view, heart rate and resolution). The images can be off-line reconstructed in any plane, avoiding the need to precisely define crosssectional planes during acquisition for each vessel. Owing to time resolved visualizations of intracardiac flow dynamics occult jets or dynamic jets might be more likely to be detected. Potential disadvantages, rsp. potential advantages to be confirmed include lower temporal resolution of 4D sequences than current 2D sequences, unknown consequences of gradient artefacts induced by new velocity encoding schemes and diagnostic plausibility of disease related image features .
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, exploratory, non-randomized, interventional study without control group.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Indication, Unlabeled
Intervention  ICMJE Device: MR data acquisition
MR data acquisition using CE and non-CE marked pulse sequences.
Study Arms  ICMJE Experimental: 4DFLOW
Acquire MR 4DFLow data.
Intervention: Device: MR data acquisition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2019) 		8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria Patients:

  • 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
  • For females in reproductive age, exclusion of pregnancy by a pregnancy test conducted before the cMRI

Exclusion Criteria Patients:

  • 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.

Inclusion Criteria Healthy Controls:

  • Absence of any contraindication to cMRI
  • Signed informed consent of participants according to current ethical rules and regulations
  • For females in reproductive age, exclusion of pregnancy by a pregnancy test conducted before the cMRI.

Exclusion Criteria Healthy Controls:

- Any contraindication for undergoing a cMRI examination per internal institutional policy of University Children's Hospital Zurich
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986645
Other Study ID Numbers  ICMJE CIV-16-11-017784
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emanuela Valsangiacomo, University Children's Hospital, Zurich
Study Sponsor  ICMJE Emanuela Valsangiacomo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emanuela Valsangiacomo, Prof. MD UChilldrenZurich
PRS Account University Children's Hospital, Zurich
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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