3D Cine Cardiovascular Magnetic Resonance

Completed

• Conditions: Congenital Heart Disease
• Interventions: Other: Cardiovascular Magnetic Resonance Imaging

• Registration Number: NCT03583775
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Conventional CMR is based on breath-hold 2D cine image acquisitions which are sequentially acquired in different imaging planes. The necessity of precisely planning and then acquiring multiple 2D imaging planes during breath-hold is relatively inefficient and leads to CMR exam times of ≤60 minutes. However, some patients are too ill or young to hold their breath. Furthermore, 2D images sometimes fail to provide a complete picture of complex 3D anatomy of patients with complex morphology.

To address these limitations, we have recently developed a 3D cine (3 spatial dimensions plus time) CMR technique. Rather than acquiring 2D cine images in multiple orientations during breath-hold, this approach allows one to acquire a free-breathing 3D block of data for each phase of cardiac cycle that can be reformatted offline into the desired views without adding to the exam time. This added efficiency should lead to a reduction in CMR exam time, increasing patient comfort, and making CMR exam easy and available for all. In addition, the 3D nature of the data may yield more complete information about the anatomy and physiology.

In this proposal, we will examine the agreement between the 2D cine and 3D cine CMR techniques with regard to left and right ventricular volumes and systemic and pulmonary blood flow circulation. The internal consistency of the measurements between the 2 techniques will be also investigated. This study will focus on children because they may benefit the most from the short, improved efficiency, and free-breathing CMR exams.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-07-11
• Study Start: 2019-11-01
• Primary Completion: 2021-09-04
• Study Completion: 2021-10-04
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Patients who are greater than 40 kg and are referred for a clinically indicated 2D CMR exam with a gadolinium-based contrast agent. Informed consent/assent will be obtained.

Exclusion Criteria

• Patients who are under anesthesia, sedated, or with a contraindication to CMR exams.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with congenital heart disease	Cardiovascular Magnetic Resonance Imaging	Patients with congenital heart disease who are greater than 40 kg and are referred for a clinically indicated 2D CMR exam with a gadolinium-based contrast agent.

Primary Outcome Measures

Name	Time	Method
End-diastolic and end-systolic volumes of right and left ventricles	1 day

Trial Locations

Locations (1)

Dr. Tarek Alsaied; 🇺🇸 Cincinnati, Ohio, United States