Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique

NCT02952287 | Terminated

• 1 other identifier: REB1000050375
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC flow method will be applied in 100 pediatric patients undergoing clinically indicated CMR with 2D PC flow measurement.

Conditions

Congenital Heart Disease (CHD)

Outcome Measures

Primary Outcomes (1)

• Pearson´s correlation coefficient (r)

  The association of variables (stroke volumes as measured with 2D and 4D flow, regurgitation fractions) will be investigated with Pearson´s correlation coefficient (r). P values of \<0.05 will be considered significant.

  Six months

Study Arms (1)

Study Participants

EXPERIMENTAL

4D PC MRI acquisition

Device: 4D PC MRI acquisition

Interventions

4D PC MRI acquisition DEVICE

Flow-sensitive 4D-MRI acquisitions will be synchronized to the heart rate and breathing using prospective ECG-gating and adaptive diaphragm navigator gating41. The MRI sequence will consist of a segmented k-space spoiled gradient echo sequence with interleaved 3D velocity encoding. Data will be acquired in a sagittal oblique 3D data volume individually adapted to include the heart and the thoracic and upper abdominal vessels of interest like ascending, transverse and descending aorta, main and branch pulmonary arteries, pulmonary veins, superior and inferior vena cava, celiac and superior mesenteric vessels. Velocity encoding (VENC) will be set at 150-500 cm/sec to encompass flow in various vessels.

Study Participants

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All pediatric patients under 18 years of age undergoing CMR with 2D PC flow measurements as a clinically indicated component of the examination at The Hospital for Sick Children, Toronto, ON.
• Ability to undergo an MRI examination without anesthesia or sedation.
• Ability to undergo an MRI examination using 'Feed-and-Sleep' technique39

You may not qualify if:

• Refusal of consent / assent by parent / legal guardian / patient
• General contraindications for an MRI examination such as non-MRI compatible metallic implants, claustrophobia.
• Patients who require anaesthesia or sedation for MRI

Sponsors & Collaborators

• The Hospital for Sick Children: lead

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shi-Joon Yoo, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Radiologist

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: November 1, 2016
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share