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临床试验/NCT03986645
NCT03986645已完成不适用

Clinical Evaluation of 4D Flow Cardiac MRI Sequences - A Prospective Exploratory Study

Emanuela Valsangiacomo0 个研究点目标入组 8 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
主要终点
Feasibility of data processing

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

4DFLOW

Experimental

Acquire MR 4DFLow data.

干预措施: MR data acquisition (Device)

结局指标

主要结局

Feasibility of data processing

时间窗: 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.

次要结局

  • Image quality(Within 72 hours after completion of exam)
  • Clinical value(Within 72 hours after completion of exam)
  • Comparability(Within 72 hours after completion of exam)

研究者

发起方
Emanuela Valsangiacomo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emanuela Valsangiacomo

Prof.

University Children's Hospital, Zurich

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