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Comparison of Magnetic Resonance Coronary Angiography (MRCA) With Coronary Computed Tomography Angiography (CTA)

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ClinicalTrials.gov Identifier: NCT03768999
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Canon Medical Systems
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

Magnetic resonance coronary angiography (MRCA) has its advantage in its ability to assess the coronary artery morphology without radiation or contrast media. The clinical application of MRCA is still challenging mainly because of technical limitations such as: its time-consuming image acquisition, inconsistent image quality, and low spatial resolution. Optimization of MRCA image acquisition method is in progress and compressed sensing (CS) with post-processing (de-noising) by deep learning reconstruction (DLR) is promising to solve these problems.

The lack of a consensus method to assess the coronary stenosis on MRCA is another issue. Generally, a stenosis in MRCA is observed as a signal intensity (SI) drop along the artery compared to the healthy segments. A previous study has reported from its comparison of MRCA with coronary angiography (CAG) that the SI drop of 35% in MRCA stenosis lesion corresponded to the significant stenosis in CAG. Although this SI drop phenomenon was not observed in a different study on chronic total obstruction cases. One of the hypothesized reasons is that the SI drop in MRCA is affected not only by the stenosis severity but also the plaque characteristics, which is not assessable by CAG. To investigate this hypothesis coronary CTA is needed, which is a robust modality to assess coronary stenosis and plaque characteristics. Comparison between MRCA with CTA has the potential to give better information for developing a robust method to assess MRCA.

In this study, the investigators aim to evaluate the feasibility of MRCA scanned with optimized protocol and post-processing, and to develop robust coronary artery assessment method on MRCA, by comparison with clinical coronary CTA.


Condition or disease Intervention/treatment
Magnetic Resonance Angiography Diagnostic Test: Non-contrast magnetic resonance coronary angiography (MRCA)

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Development of Magnetic Resonance Coronary Angiography (MRCA) Stenosis Assessment Quantification Method by Comparison With Coronary Computed Tomography Angiography (CTA)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Group/Cohort Intervention/treatment
Study group
All participants in the study to receive Non-contrast magnetic resonance coronary angiography (MRCA)
Diagnostic Test: Non-contrast magnetic resonance coronary angiography (MRCA)
Scan non-contrast MRCA and compare the image with clinically scanned coronary computed tomography angiography (CTA).




Primary Outcome Measures :
  1. The SI drop (%) threshold that corresponds to the significant stenosis in coronary CTA. [ Time Frame: After the last participant MRI scan, up to 6 months ]
    MRCA signal intensity change compared to the proximal or distal segments of the coronary artery will be measured and compared with corresponding lesion of coronary CTA. The threshold of SI drop (%) which corresponds to the significant stenosis in CTA will be assessed.


Secondary Outcome Measures :
  1. Semi-quantitative image quality assessment score for each segments in MRCA [ Time Frame: After participant's MRI scan, up to 2 weeks ]
    Image quality assessed by categorical numbers score ranging from 1 to 4 with higher scores indicating better image quality.

  2. Visible coronary length in MRCA [ Time Frame: After participant's MRI scan, up to 2 weeks ]
    The length of the coronary arteries in mm that is visually assessable which are compared with coronary CTA



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The candidate for recruitment will be clinical patients who underwent clinical coronary CTA within 6 months.
Criteria

Inclusion Criteria:

  • Participants who underwent clinical coronary CTA within 6 months and allow the study to use the image.
  • Willing to sign a consent.
  • Overall health status is rated as good/healthy other than suspected coronary artery disease
  • Weight is <300 pounds
  • Not claustrophobic
  • Age: 18 or older
  • No clear contraindication against the sublingual nitro administration

Exclusion Criteria:

  • Previous history of bypass surgery or percutaneous coronary intervention (PCI)
  • Metal fragments in the eyes, brain, or spinal cord
  • Internal electrical devices, such as a cochlear implant, spinal cord stimulator, pacemaker, or defibrillator
  • Pregnancy
  • Claustrophobia
  • Unstable angina pectoris patients
  • Taking phosphodiesterase V inhibitors (If the participant is taking this medication for erectile dysfunction and allowed to stop it for 72 hours before the MRI, the participant can be included in this study.)
  • Contraindication to use sublingual nitro administration, such as occlusive glaucoma, known allergy or severe intolerance, critical aortic stenosis. Blood pressure is not included in the exclusion criteria, but when the SBP<110 mmHg just before the cardiac MRI, the participant will not be administered the sublingual nitro.

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): NCT03768999


Contacts
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Contact: Yoko Kato, MD, Ph.D 4105024856 ykato8@jhmi.edu
Contact: Jaclyn C Sesso, BSN 8475736861 jsesso1@jhmi.edu

Locations
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United States, Maryland
Division of Cardiology, Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Canon Medical Systems
Investigators
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Principal Investigator: Joao AC Lima, MD Johns Hopkins University

Additional Information:

Publications:
Isogawa K, Ida T, Shiodera T, Takeguchi T. Deep Shrinkage Convolutional Neural Network for Adaptive Noise Reduction. IEEE Signal Process Lett. 2018;25: 224-228. doi:10.1109/LSP.2017.2782270

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03768999     History of Changes
Other Study ID Numbers: IRB00196000
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
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