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

NCT03768999 | Terminated

• 1 other identifier: IRB00196000
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnetic Resonance Angiography

Outcome Measures

Primary Outcomes (1)

• The SI drop (%) threshold that corresponds to the significant stenosis in coronary CTA.

  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.

  After the last participant MRI scan, up to 6 months

Secondary Outcomes (2)

• Semi-quantitative image quality assessment score for each segments in MRCA

  After participant's MRI scan, up to 2 weeks

• Visible coronary length in MRCA

  After participant's MRI scan, up to 2 weeks

Study Arms (1)

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)

Interventions

Non-contrast magnetic resonance coronary angiography (MRCA) DIAGNOSTIC_TEST

Scan non-contrast MRCA and compare the image with clinically scanned coronary computed tomography angiography (CTA).

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The candidate for recruitment will be clinical patients who underwent clinical coronary CTA within 6 months.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Canon Medical Systems, USA: collaborator

Study Sites (1)

Division of Cardiology, Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (9)

• Sakuma H, Ichikawa Y, Suzawa N, Hirano T, Makino K, Koyama N, Van Cauteren M, Takeda K. Assessment of coronary arteries with total study time of less than 30 minutes by using whole-heart coronary MR angiography. Radiology. 2005 Oct;237(1):316-21. doi: 10.1148/radiol.2371040830. Epub 2005 Aug 26.

  PMID: 16126921 BACKGROUND

• Akcakaya M, Basha TA, Chan RH, Rayatzadeh H, Kissinger KV, Goddu B, Goepfert LA, Manning WJ, Nezafat R. Accelerated contrast-enhanced whole-heart coronary MRI using low-dimensional-structure self-learning and thresholding. Magn Reson Med. 2012 May;67(5):1434-43. doi: 10.1002/mrm.24242. Epub 2012 Mar 5.

  PMID: 22392654 BACKGROUND

• Akcakaya M, Basha TA, Chan RH, Manning WJ, Nezafat R. Accelerated isotropic sub-millimeter whole-heart coronary MRI: compressed sensing versus parallel imaging. Magn Reson Med. 2014 Feb;71(2):815-22. doi: 10.1002/mrm.24683.

  PMID: 23440946 BACKGROUND

• Nam S, Akcakaya M, Basha T, Stehning C, Manning WJ, Tarokh V, Nezafat R. Compressed sensing reconstruction for whole-heart imaging with 3D radial trajectories: a graphics processing unit implementation. Magn Reson Med. 2013 Jan;69(1):91-102. doi: 10.1002/mrm.24234. Epub 2012 Mar 5.

  PMID: 22392604 BACKGROUND

• Nakamura M, Kido T, Kido T, Watanabe K, Schmidt M, Forman C, Mochizuki T. Non-contrast compressed sensing whole-heart coronary magnetic resonance angiography at 3T: A comparison with conventional imaging. Eur J Radiol. 2018 Jul;104:43-48. doi: 10.1016/j.ejrad.2018.04.025. Epub 2018 Apr 27.

  PMID: 29857865 BACKGROUND

• 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

  BACKGROUND

• Yonezawa M, Nagata M, Kitagawa K, Kato S, Yoon Y, Nakajima H, Nakamori S, Sakuma H, Hatakenaka M, Honda H. Quantitative analysis of 1.5-T whole-heart coronary MR angiograms obtained with 32-channel cardiac coils: a comparison with conventional quantitative coronary angiography. Radiology. 2014 May;271(2):356-64. doi: 10.1148/radiol.13122491. Epub 2013 Dec 12.

  PMID: 24475794 BACKGROUND

• Kim SM, Choi JH, Choe YH. Coronary Artery Total Occlusion: MR Angiographic Imaging Findings and Success Rates of Percutaneous Coronary Intervention according to Intraluminal Signal Intensity Patterns. Radiology. 2016 Apr;279(1):84-92. doi: 10.1148/radiol.2015150191. Epub 2015 Oct 13.

  PMID: 26465057 BACKGROUND

• Kato Y, Noda C, Ambale-Venkatesh B, Ortman JM, Kassai Y, Lima JAC, Liu CY. The mechanisms of arterial signal intensity profile in non-contrast coronary MRA (NC-MRCA): a 3D printed phantom investigation and clinical translations. Int J Cardiovasc Imaging. 2023 Jan;39(1):209-220. doi: 10.1007/s10554-022-02700-1. Epub 2022 Aug 11.

  PMID: 36598690 DERIVED

Study Officials

• Joao AC Lima, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 7, 2018
• Study Start: September 3, 2019
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (1)