Aortic CoarctationNCT02739087

Radiation-Free Heart Catheterization Using MRI

A study testing MRI guided cardiac catheterization and Magnetic resonance imaging in people with Aortic Coarctation and Cardiomyopathy, run by Joshua Kanter at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Aortic Coarctation, Cardiomyopathy, Atrial Septal Defect
What is being tested?: MRI guided cardiac catheterization and Magnetic resonance imaging
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Mar 2015to Dec 2024
Phase: Interventional
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
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Undergoing a medically necessary cardiovascular catheterization

Who cannot join

Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
Women who are pregnant
Women who are nursing and who do not plan to discard breast milk for 24 hours
Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
Central nervous system aneurysm clips
Implanted neural stimulator

Show all 12Show fewer

Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
Cochlear implant
Ocular foreign body (e.g. metal shavings)
Implanted Insulin pump
Metal shrapnel or bullet
1. Renal disease with estimated glomerular filtration rate < 30 ml/min/1.73 m2 body surface area

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

Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.

Read the detailed description

Participants undergo general anesthesia, and vascular access is obtained in the x-ray catheterization lab. Next the participant is transferred into the MRI scanner where a focused MRI examination is performed. Catheters are then guided into the heart chambers using real-time MRI guidance to perform conventional cardiac catheterization steps. If time allows, additional research MRI is performed before the participant is returned to the x-ray catheterization lab. If any MRI guided catheterization steps are unsuccessful, the clinically indicated step is performed after the participant returns to the x-ray catheterization lab using conventional x-ray guided pictures.

Conditions: Aortic Coarctation, Cardiomyopathy, Atrial Septal Defect, Aortic Stenosis, Post Heart Transplant Catheter Procedure, Patent Ductus Arteriosus
Being tested: MRI guided cardiac catheterization, Magnetic resonance imaging
Keywords: radiation free cardiac catheterization
Medical subject headings: Aortic Coarctation, Cardiomyopathies, Heart Septal Defects, Atrial, Aortic Valve Stenosis, Ductus Arteriosus, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MRI guided cardiac catheterizationProcedure or surgery
Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.
Magnetic resonance imagingDevice

Study groups in NCT02739087
Study group	Role	What they receive
MRI guided cardiac catheterization	Experimental	Magnetic resonance imaging will be used to guide cardiac catheterization procedures. Receives: Procedure: MRI guided cardiac catheterization; Device: Magnetic resonance imaging

What is being measured

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

Test the feasibility of navigating catheters into right heart structures using real-time MRI
Heart catheterization usually uses X-ray guidance. Using commercially available MRI-compatible catheters, the right heart catheterization procedure will be done using real-time magnetic resonance imaging (MRI). MRI guidance does not use X-ray radiation.
Measured: At the end of each catheterization procedure through study completion,up to 5 years.

Secondary outcomes (2)

Number of participants whose MRI cardiac catheterization procedure was prematurely terminated
Premature termination will occur under the following circumstances:
- Hemodynamic or other clinical instability
- Technical failure of catheter procedure such as being unable to navigate the catheters to the heart chamber
- Equipment malfunction
- Any other circumstance that in the opinion of the Principal Investigator poses hazard to the research subject
Measured: At the end of each catheterization procedure through study completion,up to 5 years
Measurement of radiation exposure
Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC.
Measured: End of study, 5 years.

Timeline

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

Mar 2015Dec 2024

First posted14 Apr 2016 (estimated)
Study startMar 2015
Primary completionDec 2024 (estimated)
Study completionDec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (64)Papers the sponsor has linked to this study.
Other trials for Aortic CoarctationStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02739087
Sponsor's protocol ID: 3860
Other IDs: Internal Bridge funding
Status last verified: Feb 2024
First submitted: 17 Feb 2016
Last updated: 6 Feb 2024
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance imaging: a new opportunity for image-guided interventions. JACC Cardiovasc Imaging. 2009 Nov;2(11):1321-31. doi: 10.1016/j.jcmg.2009.09.002.
PubMed 19909937
Ratnayaka K, Faranesh AZ, Guttman MA, Kocaturk O, Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance: still tantalizing. J Cardiovasc Magn Reson. 2008 Dec 29;10(1):62. doi: 10.1186/1532-429X-10-62.
PubMed 19114017
Guttman MA, Lederman RJ, Sorger JM, McVeigh ER. Real-time volume rendered MRI for interventional guidance. J Cardiovasc Magn Reson. 2002;4(4):431-42. doi: 10.1081/jcmr-120016382.
PubMed 12549231
Guttman MA, Kellman P, Dick AJ, Lederman RJ, McVeigh ER. Real-time accelerated interactive MRI with adaptive TSENSE and UNFOLD. Magn Reson Med. 2003 Aug;50(2):315-21. doi: 10.1002/mrm.10504.
PubMed 12876708
Peters DC, Lederman RJ, Dick AJ, Raman VK, Guttman MA, Derbyshire JA, McVeigh ER. Undersampled projection reconstruction for active catheter imaging with adaptable temporal resolution and catheter-only views. Magn Reson Med. 2003 Feb;49(2):216-22. doi: 10.1002/mrm.10390.
PubMed 12541240
Guttman MA, Dick AJ, Raman VK, Arai AE, Lederman RJ, McVeigh ER. Imaging of myocardial infarction for diagnosis and intervention using real-time interactive MRI without ECG-gating or breath-holding. Magn Reson Med. 2004 Aug;52(2):354-61. doi: 10.1002/mrm.20174.
PubMed 15282818
Peters DC, Guttman MA, Dick AJ, Raman VK, Lederman RJ, McVeigh ER. Reduced field of view and undersampled PR combined for interventional imaging of a fully dynamic field of view. Magn Reson Med. 2004 Apr;51(4):761-7. doi: 10.1002/mrm.20037.
PubMed 15065249
de Silva R, Gutierrez LF, Raval AN, McVeigh ER, Ozturk C, Lederman RJ. X-ray fused with magnetic resonance imaging (XFM) to target endomyocardial injections: validation in a swine model of myocardial infarction. Circulation. 2006 Nov 28;114(22):2342-50. doi: 10.1161/CIRCULATIONAHA.105.598524. Epub 2006 Nov 13.
PubMed 17101858
Guttman MA, Ozturk C, Raval AN, Raman VK, Dick AJ, DeSilva R, Karmarkar P, Lederman RJ, McVeigh ER. Interventional cardiovascular procedures guided by real-time MR imaging: an interactive interface using multiple slices, adaptive projection modes and live 3D renderings. J Magn Reson Imaging. 2007 Dec;26(6):1429-35. doi: 10.1002/jmri.21199.
PubMed 17968897
Kocaturk O, Kim AH, Saikus CE, Guttman MA, Faranesh AZ, Ozturk C, Lederman RJ. Active two-channel 0.035'' guidewire for interventional cardiovascular MRI. J Magn Reson Imaging. 2009 Aug;30(2):461-5. doi: 10.1002/jmri.21844.
PubMed 19629968
Kocaturk O, Saikus CE, Guttman MA, Faranesh AZ, Ratnayaka K, Ozturk C, McVeigh ER, Lederman RJ. Whole shaft visibility and mechanical performance for active MR catheters using copper-nitinol braided polymer tubes. J Cardiovasc Magn Reson. 2009 Aug 12;11(1):29. doi: 10.1186/1532-429X-11-29.
PubMed 19674464
George AK, Derbyshire JA, Saybasili H, Saikus CE, Kocaturk O, Guttman MA, McVeigh ER, Lederman RJ, Faranesh AZ. Visualization of active devices and automatic slice repositioning ("SnapTo") for MRI-guided interventions. Magn Reson Med. 2010 Apr;63(4):1070-9. doi: 10.1002/mrm.22307.
PubMed 20373408
Saybasili H, Derbyshire JA, Kellman P, Griswold MA, Ozturk C, Lederman RJ, Seiberlich N. RT-GROG: parallelized self-calibrating GROG for real-time MRI. Magn Reson Med. 2010 Jul;64(1):306-12. doi: 10.1002/mrm.22351.
PubMed 20577983
Derbyshire JA, Herzka DA, McVeigh ER, Lederman RJ. Efficient implementation of hardware-optimized gradient sequences for real-time imaging. Magn Reson Med. 2010 Dec;64(6):1814-20. doi: 10.1002/mrm.22211.
PubMed 20878764
Sampath S, Raval AN, Lederman RJ, McVeigh ER. High-resolution 3D arteriography of chronic total peripheral occlusions using a T1-W turbo spin-echo sequence with inner-volume imaging. Magn Reson Med. 2007 Jan;57(1):40-9. doi: 10.1002/mrm.21098.
PubMed 17152076

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitation
Effects of Exercise in Patients With Repaired Coarctation of the Aorta
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Enrolling by invitationObservational study
The Arch Watch Study: An Integrated Evaluation of Hemodynamics in Infants With Suspected Coarctation of the Aorta
Coarctation of the Aorta, Aortic Arch Obstruction
RecruitingObservational study
Valvular Aortic Stenosis Prognosis Study
Morality
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First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
Aortic Coarctation, Pulmonary Artery Stenosis

All Aortic Coarctation trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radiation-Free Heart Catheterization Using MRI
ClinicalTrials.gov ID: NCT02739087
Acronym / sponsor ID: 3860
Conditions: Aortic Coarctation, Cardiomyopathy, Atrial Septal Defect, Aortic Stenosis, Post Heart Transplant Catheter Procedure, Patent Ductus Arteriosus
Keywords: radiation free cardiac catheterization
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Joshua KanterUniversity, hospital or other
Study start: Mar 2015
Primary completion: Dec 2024 (estimated)
Study completion: Dec 2024 (estimated)
First posted: 14 Apr 2016 (estimated)
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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MRI guided cardiac catheterization	Experimental	Procedure: MRI guided cardiac catheterization, Device: Magnetic resonance imagingMagnetic resonance imaging will be used to guide cardiac catheterization procedures.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Undergoing a medically necessary cardiovascular catheterization

Key exclusion criteria (12 listed)

Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
Women who are pregnant
Women who are nursing and who do not plan to discard breast milk for 24 hours
Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
1. Renal disease with estimated glomerular filtration rate < 30 ml/min/1.73 m2 body surface area

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
MRI guided cardiac catheterizationMagnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.	Procedure or surgery	MRI guided cardiac catheterization
Magnetic resonance imaging	Device	MRI guided cardiac catheterization

Primary outcome

Test the feasibility of navigating catheters into right heart structures using real-time MRI
Time frame: At the end of each catheterization procedure through study completion,up to 5 years.
Heart catheterization usually uses X-ray guidance. Using commercially available MRI-compatible catheters, the right heart catheterization procedure will be done using real-time magnetic resonance imaging (MRI). MRI guidance does not use X-ray radiation.

2 secondary outcomes

Number of participants whose MRI cardiac catheterization procedure was prematurely terminated
Time frame: At the end of each catheterization procedure through study completion,up to 5 years
Measurement of radiation exposure
Time frame: End of study, 5 years.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
Background: PubMed 19909937Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance imaging: a new opportunity for image-guided interventions. JACC Cardiovasc Imaging. 2009 Nov;2(11):1321-31. doi: 10.1016/j.jcmg.2009.09.002.
Background: PubMed 19114017Ratnayaka K, Faranesh AZ, Guttman MA, Kocaturk O, Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance: still tantalizing. J Cardiovasc Magn Reson. 2008 Dec 29;10(1):62. doi: 10.1186/1532-429X-10-62.
Background: PubMed 12549231Guttman MA, Lederman RJ, Sorger JM, McVeigh ER. Real-time volume rendered MRI for interventional guidance. J Cardiovasc Magn Reson. 2002;4(4):431-42. doi: 10.1081/jcmr-120016382.
Background: PubMed 12876708Guttman MA, Kellman P, Dick AJ, Lederman RJ, McVeigh ER. Real-time accelerated interactive MRI with adaptive TSENSE and UNFOLD. Magn Reson Med. 2003 Aug;50(2):315-21. doi: 10.1002/mrm.10504.
Background: PubMed 12541240Peters DC, Lederman RJ, Dick AJ, Raman VK, Guttman MA, Derbyshire JA, McVeigh ER. Undersampled projection reconstruction for active catheter imaging with adaptable temporal resolution and catheter-only views. Magn Reson Med. 2003 Feb;49(2):216-22. doi: 10.1002/mrm.10390.
Background: PubMed 15282818Guttman MA, Dick AJ, Raman VK, Arai AE, Lederman RJ, McVeigh ER. Imaging of myocardial infarction for diagnosis and intervention using real-time interactive MRI without ECG-gating or breath-holding. Magn Reson Med. 2004 Aug;52(2):354-61. doi: 10.1002/mrm.20174.
Background: PubMed 15065249Peters DC, Guttman MA, Dick AJ, Raman VK, Lederman RJ, McVeigh ER. Reduced field of view and undersampled PR combined for interventional imaging of a fully dynamic field of view. Magn Reson Med. 2004 Apr;51(4):761-7. doi: 10.1002/mrm.20037.
Background: PubMed 17101858de Silva R, Gutierrez LF, Raval AN, McVeigh ER, Ozturk C, Lederman RJ. X-ray fused with magnetic resonance imaging (XFM) to target endomyocardial injections: validation in a swine model of myocardial infarction. Circulation. 2006 Nov 28;114(22):2342-50. doi: 10.1161/CIRCULATIONAHA.105.598524. Epub 2006 Nov 13.
Background: PubMed 17968897Guttman MA, Ozturk C, Raval AN, Raman VK, Dick AJ, DeSilva R, Karmarkar P, Lederman RJ, McVeigh ER. Interventional cardiovascular procedures guided by real-time MR imaging: an interactive interface using multiple slices, adaptive projection modes and live 3D renderings. J Magn Reson Imaging. 2007 Dec;26(6):1429-35. doi: 10.1002/jmri.21199.
Background: PubMed 19629968Kocaturk O, Kim AH, Saikus CE, Guttman MA, Faranesh AZ, Ozturk C, Lederman RJ. Active two-channel 0.035'' guidewire for interventional cardiovascular MRI. J Magn Reson Imaging. 2009 Aug;30(2):461-5. doi: 10.1002/jmri.21844.
Background: PubMed 19674464Kocaturk O, Saikus CE, Guttman MA, Faranesh AZ, Ratnayaka K, Ozturk C, McVeigh ER, Lederman RJ. Whole shaft visibility and mechanical performance for active MR catheters using copper-nitinol braided polymer tubes. J Cardiovasc Magn Reson. 2009 Aug 12;11(1):29. doi: 10.1186/1532-429X-11-29.
Background: PubMed 20373408George AK, Derbyshire JA, Saybasili H, Saikus CE, Kocaturk O, Guttman MA, McVeigh ER, Lederman RJ, Faranesh AZ. Visualization of active devices and automatic slice repositioning ("SnapTo") for MRI-guided interventions. Magn Reson Med. 2010 Apr;63(4):1070-9. doi: 10.1002/mrm.22307.
Individual participant dataSharing planned: No

Related trials for Aortic Coarctation

RecruitingPhase 3
A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)
Coarctation of Aorta, High Blood Pressure
Enrolling by invitation
Effects of Exercise in Patients With Repaired Coarctation of the Aorta
Coarctation of the Aorta, Coarctation of Aorta
Enrolling by invitationObservational study
The Arch Watch Study: An Integrated Evaluation of Hemodynamics in Infants With Suspected Coarctation of the Aorta
Coarctation of the Aorta, Aortic Arch Obstruction
RecruitingObservational study
Valvular Aortic Stenosis Prognosis Study
Morality
Not yet recruiting
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
Aortic Coarctation, Pulmonary Artery Stenosis

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.

Joshua Kanter, MD principal investigator

Children's National Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MRI guided cardiac catheterization and Magnetic resonance imaging in people with Aortic Coarctation and Cardiomyopathy, run by Joshua Kanter 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 12 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. 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?

Results are not available in the source record.

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?

Test the feasibility of navigating catheters into right heart structures using real-time MRI (time frame: At the end of each catheterization procedure through study completion,up to 5 years.). 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 NCT02739087, which also lists 64 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 6 Feb 2024.