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3D Cine Cardiovascular Magnetic Resonance

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ClinicalTrials.gov Identifier: NCT03583775
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Mehdi Hedjazi Moghari, Boston Children's Hospital

Study Description
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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.


Condition or disease Intervention/treatment
Congenital Heart Disease Other: Cardiovascular Magnetic Resonance Imaging

Study Design
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Study Type : Observational
Estimated Enrollment : 51 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comprehensive Free-breathing 3D Cine Cardiovascular Magnetic Resonance
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : September 4, 2022
Estimated Study Completion Date : September 4, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Cardiovascular Magnetic Resonance Imaging or MRI exam from children's with congenital heart disease


Outcome Measures
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Primary Outcome Measures :
  1. End-diastolic and end-systolic volumes of right and left ventricles [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with different races and ethnicity are included in the study.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583775


Contacts
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Contact: Mehdi Hedjazi Moghari, PhD 617-533-1556 mehdi.hedjazimoghari@cardio.chboston.org
Contact: Andrew J Powell, MD 617-355-8799 andrew.powell@cardio.chboston.org

Locations
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United States, Ohio
Dr. Tarek Alsaied Recruiting
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Boston Children's Hospital
More Information
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Responsible Party: Mehdi Hedjazi Moghari, Assistant Professor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03583775    
Other Study ID Numbers: IRB-P00028262
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities