3D Cine Cardiovascular Magnetic Resonance

NCT ID: NCT03583775

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-10-04

Brief Summary

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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

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cardiovascular Magnetic Resonance Imaging

Intervention Type OTHER

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

Interventions

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Cardiovascular Magnetic Resonance Imaging

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Andrew Powell

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Tarek Alsaied

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-P00028262

Identifier Type: -

Identifier Source: org_study_id

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