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Congenital Heart DiseaseNCT02892136

Technical Development for Pediatric Cardiovascular MRI

An observational study of Congenital Heart Disease and Cardiovascular Disease, run by Children's National Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate pediatric patients with cardiovascular disease,congenital heart disease in patients of all ages, fetuses undergoing clinically indicated MR imaging. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
How many people
5,000 participants
Where
1 siteUnited States
Study dates
May 2013to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Individuals referred to Children's National Medical Center for a clinically indicated cardiac MRI or cardiac catheterization by their primary referring cardiologist will be considered potential candidates for inclusion in technical development research. Technical development work often depends on preliminary studies in healthy volunteers. This protocol also enrolls healthy subjects.

Who may be able to join

  • Clinically indicated exams
  • Patients who are undergoing a medically indicated MRI scan or cardiac catheterization procedure
  • Patients who are medically judged to have no contraindications to MRI scan
  • Age inclusion: infant to adult
  • Written informed consent and assent, when applicable
  • Volunteers
Show all 11Show fewer
  • Written informed consent from any normal volunteer 8 years of age or older for a noncontrast, nonsedated cardiac MRI
  • Normal adult volunteer to undergo cardiac MRI with contrast agent
  • Fetal exams
  • Age inclusion:18 years and older
  • Second or third trimester (greater than 13 weeks)

Who cannot join

  • All patients who are medically judged to have contraindication(s) to MRI scanning will be excluded. Contraindications include implanted metal devices which are contraindicated for MRI scanning:
  • Central nervous system aneurysm clips;
  • Implanted neural stimulator;
  • Implanted cardiac pacemaker or defibrillator;
  • Cochlear implant;
  • Ocular foreign body (e.g. metal shavings);
Show all 26Show fewer
  • Implanted Insulin pump;
  • Metal shrapnel or bullet.
  • Exclusion criteria for Bicycle Stress MRI
  • Myocardial infarction within 24 hours
  • Active myocarditis
  • Uncontrolled heart failure
  • Severe left ventricular outflow tract obstruction
  • Exclusion Criteria for adult volunteers undergoing MRI with administration of contrast agent:
  • 60 years of age or older
  • Renal Disease; Glomerular Filtration rate (eGFR < 30 ml/min/1.73 m2) will be determined by a simple blood test done at the bedside
  • Use of diuretics
  • Diagnosis of hypertension and diabetes
  • Exclusion criteria for volunteers undergoing both contrast and non-contrast
  • MRI scans:
  • Pregnant women:
  • Women of childbearing potential will be required to have a screening urine pregnancy test
  • Exclusion criteria for
  • Pregnant woman for whom 15 additional minutes lying flat in the MR scanner would represent a risk (i.e. severe claustrophobia, congestive heart failure)
  • Pregnant minor under the age of 18
  • Less than 13 weeks gestation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's National Health System

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate pediatric patients with cardiovascular disease,congenital heart disease in patients of all ages, fetuses undergoing clinically indicated MR imaging.

Read the detailed description

The purpose of this protocol is to allow development and testing of new MRI techniques suitable for evaluating patients with cardiovascular disease, congenital heart disease, fetal cardiac structure, function, and physiology, and other fetal organ analysis. Individuals referred to Children's National Medical Center for a clinically indicated cardiac MRI or cardiac catheterization by their primary referring cardiologist or obstetrician, and who are enrolled in this study may also undergo additional research imaging.

Since such technical development work often depends on preliminary studies in healthy volunteers, the protocol also recruits healthy subjects.

Medical subject headings
Heart Defects, Congenital, Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate innovative noninvasive MRI techniques suitable for evaluating pediatric patients with cardiovascular disease, congenital cardiac disease, and fetal organ analysis including cardiac structure, function, and physiology.

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)

  1. Natural history of congenital heart disease

    A secondary objective of this protocol is to catalog results from MR imaging studies that can be used to describe the natural history of congenital heart disease and other cardiovascular diseases acquired in the young.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2016 (estimated)
  2. Study startMay 2013
  3. Primary completionMay 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02892136
Sponsor's protocol ID
2359
Status last verified
Apr 2022
First submitted
21 Jul 2016
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Beerbaum P, Sarikouch S, Laser KT, Greil G, Burchert W, Korperich H. Coronary anomalies assessed by whole-heart isotropic 3D magnetic resonance imaging for cardiac morphology in congenital heart disease. J Magn Reson Imaging. 2009 Feb;29(2):320-7. doi: 10.1002/jmri.21655.

    PubMed 19161183

  • Didier D, Ratib O, Beghetti M, Oberhaensli I, Friedli B. Morphologic and functional evaluation of congenital heart disease by magnetic resonance imaging. J Magn Reson Imaging. 1999 Nov;10(5):639-55. doi: 10.1002/(sici)1522-2586(199911)10:53.0.co;2-l.

    PubMed 10548772

  • Frakes DH, Smith MJ, Parks J, Sharma S, Fogel SM, Yoganathan AP. New techniques for the reconstruction of complex vascular anatomies from MRI images. J Cardiovasc Magn Reson. 2005;7(2):425-32. doi: 10.1081/jcmr-200053637.

    PubMed 15881525

  • Krishnamurthy R. Pediatric cardiac MRI: anatomy and function. Pediatr Radiol. 2008 May;38 Suppl 2:S192-9. doi: 10.1007/s00247-008-0786-0. No abstract available.

    PubMed 18401610

  • Sarikouch S, Peters B, Gutberlet M, Leismann B, Kelter-Kloepping A, Koerperich H, Kuehne T, Beerbaum P. Sex-specific pediatric percentiles for ventricular size and mass as reference values for cardiac MRI: assessment by steady-state free-precession and phase-contrast MRI flow. Circ Cardiovasc Imaging. 2010 Jan;3(1):65-76. doi: 10.1161/CIRCIMAGING.109.859074. Epub 2009 Oct 9.

    PubMed 19820203

  • Uribe S, Muthurangu V, Boubertakh R, Schaeffter T, Razavi R, Hill DL, Hansen MS. Whole-heart cine MRI using real-time respiratory self-gating. Magn Reson Med. 2007 Mar;57(3):606-13. doi: 10.1002/mrm.21156.

    PubMed 17326164

  • Valverde I, Parish V, Tzifa A, Head C, Sarikouch S, Greil G, Schaeffter T, Razavi R, Beerbaum P. Cardiovascular MR dobutamine stress in adult tetralogy of Fallot: disparity between CMR volumetry and flow for cardiovascular function. J Magn Reson Imaging. 2011 Jun;33(6):1341-50. doi: 10.1002/jmri.22573.

    PubMed 21591002

  • Beerbaum P, Korperich H, Barth P, Esdorn H, Gieseke J, Meyer H. Noninvasive quantification of left-to-right shunt in pediatric patients: phase-contrast cine magnetic resonance imaging compared with invasive oximetry. Circulation. 2001 May 22;103(20):2476-82. doi: 10.1161/01.cir.103.20.2476.

    PubMed 11369688

  • Beerbaum P, Korperich H, Gieseke J, Barth P, Peuster M, Meyer H. Rapid left-to-right shunt quantification in children by phase-contrast magnetic resonance imaging combined with sensitivity encoding (SENSE). Circulation. 2003 Sep 16;108(11):1355-61. doi: 10.1161/01.CIR.0000087603.97036.C2. Epub 2003 Aug 25.

    PubMed 12939211

  • Bell A, Beerbaum P, Greil G, Hegde S, Toschke AM, Schaeffter T, Razavi R. Noninvasive assessment of pulmonary artery flow and resistance by cardiac magnetic resonance in congenital heart diseases with unrestricted left-to-right shunt. JACC Cardiovasc Imaging. 2009 Nov;2(11):1285-91. doi: 10.1016/j.jcmg.2009.07.009.

    PubMed 19909932

  • Korperich H, Gieseke J, Barth P, Hoogeveen R, Esdorn H, Peterschroder A, Meyer H, Beerbaum P. Flow volume and shunt quantification in pediatric congenital heart disease by real-time magnetic resonance velocity mapping: a validation study. Circulation. 2004 Apr 27;109(16):1987-93. doi: 10.1161/01.CIR.0000126494.66859.A2. Epub 2004 Apr 5.

    PubMed 15066942

  • Uribe S, Beerbaum P, Sorensen TS, Rasmusson A, Razavi R, Schaeffter T. Four-dimensional (4D) flow of the whole heart and great vessels using real-time respiratory self-gating. Magn Reson Med. 2009 Oct;62(4):984-92. doi: 10.1002/mrm.22090.

    PubMed 19672940

  • Hansen MS, Kozerke S, Pruessmann KP, Boesiger P, Pedersen EM, Tsao J. On the influence of training data quality in k-t BLAST reconstruction. Magn Reson Med. 2004 Nov;52(5):1175-83. doi: 10.1002/mrm.20256.

    PubMed 15508162

  • Lardo AC. Real-time magnetic resonance imaging: diagnostic and interventional applications. Pediatr Cardiol. 2000 Jan-Feb;21(1):80-98. doi: 10.1007/s002469910010.

    PubMed 10672617

  • Muthurangu V, Lurz P, Critchely JD, Deanfield JE, Taylor AM, Hansen MS. Real-time assessment of right and left ventricular volumes and function in patients with congenital heart disease by using high spatiotemporal resolution radial k-t SENSE. Radiology. 2008 Sep;248(3):782-91. doi: 10.1148/radiol.2482071717. Epub 2008 Jul 15.

    PubMed 18632528

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Heart Disease and Cardiovascular Disease, run by Children's National Research Institute 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 11 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 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?

This study is still under way. Results are not available in the source record yet.

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?

To evaluate innovative noninvasive MRI techniques suitable for evaluating pediatric patients with cardiovascular disease, congenital cardiac disease, and fetal organ analysis including cardiac structure, function, and physiology. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02892136, which also lists 53 linked publications.

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 14 Apr 2022.

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