Congenital Heart DiseaseNCT03583775
3D Cine Cardiovascular Magnetic Resonance
An observational study of Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Cardiovascular Magnetic Resonance Imaging
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 4 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with different races and ethnicity are included in the study.
Who may be able to join
- 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.
Who cannot join
- Patients who are under anesthesia, sedated, or with a contraindication to CMR exams.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Free-breathing 3D Cine Cardiovascular Magnetic Resonance
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
- Being tested
- Cardiovascular Magnetic Resonance Imaging
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Magnetic Resonance ImagingOther
Cardiovascular Magnetic Resonance Imaging or MRI exam from children's with congenital heart disease
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cardiovascular Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-diastolic and end-systolic volumes of right and left ventricles
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 Nov 2019
- Primary completion4 Sep 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Powell, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583775
- Sponsor's protocol ID
- IRB-P00028262
- Status last verified
- Mar 2022
- First submitted
- 27 Jun 2018
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Free-breathing 3D Cine Cardiovascular Magnetic Resonance
- ClinicalTrials.gov ID
- NCT03583775
- Acronym / sponsor ID
- IRB-P00028262
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 4 Sep 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with congenital heart disease | – | Other: Cardiovascular Magnetic Resonance ImagingPatients 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with different races and ethnicity are included in the study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who are under anesthesia, sedated, or with a contraindication to CMR exams.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Magnetic Resonance ImagingCardiovascular Magnetic Resonance Imaging or MRI exam from children's with congenital heart disease | Other | Patients with congenital heart disease |
Primary outcome
End-diastolic and end-systolic volumes of right and left ventricles
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Disease
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-diastolic and end-systolic volumes of right and left ventricles (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.