Comprehensive Free-breathing 3D Cine Cardiovascular Magnetic Resonance

3D Cine Cardiovascular Magnetic Resonance



Sponsors


Source

Boston Children’s Hospital

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-09-04

Completion Date

2024-09-04

Primary Completion Date

2022-09-04

Study Type

Observational

Primary Outcome

Measure

Time Frame

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

Number Of Groups

1

Enrollment

51

Condition


Intervention

Intervention Type

Other

Intervention Name


Description

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

Arm Group Label

Patients with congenital heart disease


Eligibility

Study Pop

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

Sampling Method

Non-Probability Sample

Criteria

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.

Gender

All

Minimum Age

N/A

Maximum Age

N/A


Overall Contact

Last Name

Mehdi Hedjazi Moghari, PhD

Phone

617-533-1556

Email



Verification Date

2018-06-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Boston Children’s Hospital

Investigator Full Name

Mehdi Hedjazi Moghari

Investigator Title

Assistant Professor


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

Patients with congenital heart disease

Description

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.


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Andrew J Powell, MD

Phone

617-355-8799

Email



Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Other

Time Perspective

Prospective


Study First Submitted

June 27, 2018

Study First Submitted Qc

June 27, 2018

Study First Posted

July 11, 2018

Last Update Submitted

June 27, 2018

Last Update Submitted Qc

June 27, 2018

Last Update Posted

July 11, 2018


ClinicalTrials.gov processed this data on July 11, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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