3D Cine Cardiovascular Magnetic Resonance

Congenital Heart Disease Clinical Trial

Official title:

Comprehensive Free-breathing 3D Cine Cardiovascular Magnetic Resonance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583775
• Other study ID #: IRB-P00028262
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: October 4, 2021

Study information

• Verified date: March 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 4, 2021
• Est. primary completion date: September 4, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Cardiovascular Magnetic Resonance Imaging
Cardiovascular Magnetic Resonance Imaging or MRI exam from children's with congenital heart disease

Locations

Country	Name	City	State
United States	Dr. Tarek Alsaied	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End-diastolic and end-systolic volumes of right and left ventricles		1 day