3D Cine Cardiovascular Magnetic Resonance

NCT03583775 | Completed

• 1 other identifier: IRB-P00028262
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• End-diastolic and end-systolic volumes of right and left ventricles

  1 day

Study Arms (1)

Patients with congenital heart disease

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.

Other: Cardiovascular Magnetic Resonance Imaging

Interventions

Cardiovascular Magnetic Resonance Imaging OTHER

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

Patients with congenital heart disease

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with different races and ethnicity are included in the study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Dr. Tarek Alsaied

Cincinnati, Ohio, 45229, United States

Location

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 Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 11, 2018
• Study Start: November 1, 2019
• Primary Completion: September 4, 2021
• Study Completion: October 4, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)