Low SAR MRI Scans for Coronary Heart Disease

Overseen By Anastasia Tsakirellis, C.R.N.P.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Must be taking: Bronchodilators

Must not be taking: Antidepressants, others

Disqualifiers: Pregnancy, Unstable angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

2950 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new MRI scanner that uses lower energy levels, making it safer for individuals with metal implants or undergoing procedures with metal tools. The goal is to improve the quality of images taken of the heart and other organs. Participants may undergo both the new and a standard MRI to compare results. The trial seeks adults who are either healthy or have heart or non-heart-related diseases, such as stable heart disease or lung conditions like asthma. As an unphased trial, participants can help advance safer imaging technology for future medical procedures.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that certain conditions and medications may affect eligibility, such as severe chronic obstructive pulmonary disease requiring multiple bronchodilators or continuous oxygen. It's best to discuss your specific medications with the trial team.

What prior data suggests that this MRI scanner is safe for use?

Research shows that MRI scans, including the new low-energy MRI being tested, are generally safe. Studies have found that MRI machines carefully control energy levels to stay within FDA-set safe limits, ensuring the energy absorbed by the body remains safe.

MRI safety is often a concern for people with heart devices. However, recent studies suggest that MRI can be safely performed in these individuals if certain precautions are taken. The low-energy MRI aims to further reduce risk by using less energy.

Most people tolerate MRI scans well. Some might experience minor discomfort, such as warmth or anxiety from being inside the machine. Serious side effects are rare. In this study, participants may choose to receive a contrast dye or heart medicine to improve images, which can cause temporary side effects like chest pain or shortness of breath, but these are usually manageable.

In summary, current evidence suggests that the new MRI technique is expected to be safe and well-tolerated for most participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Low SAR MRI scans for coronary heart disease because these scans offer a safer imaging method for patients with cardiovascular conditions. Unlike traditional MRI scans, which can pose risks for individuals with metallic implants, Low SAR (Specific Absorption Rate) MRI scans are designed to be safer and more compatible with such devices. This technique could potentially allow for broader and more frequent use of MRI imaging in patients with heart disease, providing clearer insights into their condition without the associated risks of high-energy imaging.

What evidence suggests that this MRI scanner is effective for coronary heart disease?

Research has shown that MRI is useful for assessing heart function and damage after a heart attack. It helps doctors plan treatment by identifying issues with heart muscles and blood flow. In this trial, participants will be divided into groups to evaluate the new low-energy MRI scanner. This scanner uses less power, potentially making it safer for individuals with metal implants. Studies suggest that this new scanner can still produce clear images while reducing energy exposure. This improvement could make MRIs accessible to more people, especially those with metal devices in their bodies. ^{1 2 6 7 8}

Who Is on the Research Team?

Adrienne E Campbell, Ph.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older, both with coronary heart disease and healthy volunteers. Participants must be willing to follow study procedures, including food restrictions, and provide written consent. Those with allergies to certain contrast agents or severe medical conditions making MRI unsafe are excluded.

Inclusion Criteria

Willingness to cooperate with all study procedures (including food restriction) and available for scheduled study events

I have a known heart condition.

I do not have any known brain conditions or injuries.

Exclusion Criteria

A history of reaction to oral contrast (if using barium sulfate), breastfeeding unless subject is willing to discard breast milk for 24 hours (if using barium sulfate), allergy to pineapple (if using pineapple juice), does not wish to be exposed to oral contrast (for oral contrast agent)

Important past medical illness (for Healthy Volunteers)

I have not been exposed to a specific contrast agent if my kidney function is below a certain level.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

MRI Scanning

Participants undergo MRI scanning using both the new low SAR MRI and conventional MRI, with optional gadolinium injection and vasodilator administration

Up to 2 hours per session

1-2 visits (in-person)

Follow-up

Participants are monitored for any adverse effects and the accuracy of MRI results is assessed

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI scan
• MRI scans

Trial Overview Researchers are testing a new low-energy MRI scanner system that could be safer for patients with metal implants. The study involves comparing images from the new scanner against conventional MRIs, possibly using a dye or drug to enhance image quality.

How Is the Trial Designed?

Group I: Group C Experimental Treatment 1 Intervention

Group C includes 500 adult subjects of both sexes with known non-cardiovascular disease

Group II: Group B Experimental Treatment 1 Intervention

Group B includes 500 adult subjects of both sexes with known sta-ble cardiovascular disease including adults with stable coronary artery disease after myocardial infarction; adults with heart failure and reduced left ventricular systolic function; adults with pulmonary artery hypertension; adults with congenital heart disease including cardiac shunts; adults with valvular heart disease including aortic stenosis, mitral regurgitation, and tricuspid regurgitation; and adults with metallic cardiovascular implants (such as coronary and peripheral artery stents) known to be safe for CMR at 1.5T

Group III: Group A Experimental Treatment 2 Interventions

Group A includes 600 healthy adult volunteers of both sexes with-out known cardiovascular disease

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Magnetic resonance imaging (MRI) is a safe imaging technique that does not use ionizing radiation, but it requires special safety precautions due to the strong magnetic fields involved.

The American College of Radiology has updated its guidelines on MRI safety, reflecting the evolution of safety recommendations and procedures to ensure patient and staff safety during MR imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulating MR Safety Standards. MacIntyre, S.[2021]

In a study involving 14 patients with various cardiac devices, all 16 MRI scans at 3T were completed successfully without any arrhythmias or significant changes in device parameters, indicating that 3T MRI can be safely performed on cardiac device patients with proper precautions.

The study highlights the importance of careful device reprogramming and extensive monitoring during the MRI process, allowing for safe imaging while minimizing risks associated with the magnetic field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of implantable cardiac rhythm devices at 3.0 tesla. Gimbel, JR.[2008]

Magnetic resonance imaging (MRI) has significant potential for diagnosing ischemic heart disease, allowing multiple aspects of the condition to be evaluated in a single session, which could greatly enhance patient management.

Recent advancements, such as high-resolution coronary MRI and the development of blood pool contrast agents, are expected to improve vessel visualization and myocardial perfusion imaging, establishing MRI as a new gold standard for assessing heart function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of ischemic heart disease: why cardiac magnetic resonance imaging will play a significant role in the management of patients with coronary artery disease. de Roos, A., Kunz, P., Lamb, H., et al.[2019]

Cardiovascular magnetic resonance (CMR) has advanced techniques that allow for effective imaging of coronary arteries, overcoming challenges like motion and respiration, which enhances the clarity of the images.

Recent innovations in CMR, such as steady state imaging and intravascular contrast agents, suggest that it could soon become a widely used clinical tool for assessing coronary artery conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR coronary angiography: 2001 update. Bunce, NH., Lorenz, CH., Pennell, DJ.[2005]

Cardiac magnetic resonance (MR) imaging performed within 14 days after coronary stent implantation in patients with acute myocardial infarction is safe, showing no significant increase in adverse cardiovascular events compared to a control group that did not undergo imaging.

In a study of 66 patients who underwent MR imaging shortly after stent placement, the event-free survival rate at 6 months was 91%, similar to the 83.7% in the control group, indicating that MR imaging does not negatively impact patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute myocardial infarction: safety of cardiac MR imaging after percutaneous revascularization with stents. Patel, MR., Albert, TS., Kandzari, DE., et al.[2007]

Magnetic resonance imaging (MRI) is a crucial tool for evaluating patients with coronary disease, particularly for assessing ventricular function and determining treatment options, although it is still underutilized.

MRI techniques, such as late enhancement, provide detailed insights into post-infarction necrosis and are valuable for preoperative assessments of ventricular remodeling, but routine use for examining coronary morphology and stenosis is not yet standard practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indications for MRI in coronary disease]. Dacher, JN., Bertrand, D., Gahide, G., et al.[2016]

Coronary MR angiography, developed in 1991, has proven effective in detecting coronary artery variants and imaging coronary stents and bypass grafts, although its role in screening for coronary artery lesions is still being established.

The use of MR contrast agents enhances the imaging techniques, and despite rapid advancements in coronary MR angiography, large-scale preclinical trials for many early techniques have not been conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary MR angiography. Duerinckx, AJ.[2019]

In a study involving 148,489 patients over 10 years, gadoteric acid (Dotarem®) was found to be a safe MRI contrast agent, with only 0.3% of patients experiencing adverse events, primarily mild symptoms like nausea and vomiting.

The diagnostic effectiveness was high, with 99.8% of examinations yielding useful results and excellent or good image quality in 97.7% of cases, indicating that gadoteric acid is effective for routine MRI procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. Braun, J., Busse, R., Darmon-Kern, E., et al.[2020]

Stress cardiac MRI is an effective noninvasive method for diagnosing coronary artery disease (CAD), showing good sensitivity (83% for wall motion abnormalities and 91% for perfusion imaging) and specificity (86% for wall motion abnormalities and 81% for perfusion imaging) based on a review of 37 studies involving 2,191 patients.

Both imaging techniques are particularly reliable in populations with high disease prevalence, but there is limited data on their effectiveness in populations with low disease prevalence, indicating a need for further research in those groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of stress cardiac magnetic resonance imaging in the detection of coronary artery disease: a meta-analysis. Nandalur, KR., Dwamena, BA., Choudhri, AF., et al.[2022]

Cardiovascular magnetic resonance imaging (CMR) is crucial for diagnosing and assessing heart failure, providing accurate and reproducible evaluations without the use of radiation.

CMR not only helps identify the cause of heart failure but also offers detailed insights into heart structure and function, including the assessment of conditions like iron overload cardiomyopathy and emerging roles in cardiac amyloid and Anderson-Fabry disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Cardiovascular Magnetic Resonance Imaging in Heart Failure. Peterzan, MA., Rider, OJ., Anderson, LJ.[2021]

Magnetic resonance imaging (MRI) shows promise as a noninvasive and low-risk method for screening individuals at risk for coronary heart disease, despite challenges like heart and lung movement and the complex structure of coronary arteries.

Various research groups are exploring advanced imaging techniques and contrast agents to improve coronary artery visualization, with ongoing promising results, although a definitive optimal method has not yet been established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance coronary artery imaging. Paschal, CB., Haacke, EM., Adler, LP., et al.[2019]

Magnetic resonance imaging (MRI) is generally considered both safe and effective for diagnostic purposes, with ongoing improvements in technology and clinical practices enhancing its safety profile.

The article reviews various safety considerations related to MRI operations, highlighting the importance of understanding both bioeffects and operational safety issues based on extensive clinical experience and reported incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operational safety issues in MRI. Gangarosa, RE., Minnis, JE., Nobbe, J., et al.[2019]

Cardiac MRI is a promising tool for diagnosing coronary artery disease, offering advantages such as evaluating coronary arteries, measuring blood flow, and assessing the viability of heart tissue affected by ischemia.

This review highlights the potential of MRI to enhance the integrated approach to diagnosing ischemic heart disease, which currently relies on multiple imaging techniques like x-ray angiography and echocardiography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance of Coronary Artery Disease in the Elderly. Shaaban, AM., Duerinckx, AJ.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03331380

Study Details | NCT03331380 | Technical Development of ... We propose a method of CMR that can be performed with low SAR but that nevertheless preserves image quality because of efficient use of CMR signal.

2. withpower.com withpower.com/trial/phase-2018-9cc4a

Low SAR MRI Scans for Coronary Heart Disease MRI is effective in assessing heart function and damage after a heart attack, helping doctors plan treatment. It can also detect heart muscle issues and blood ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5659627/

Low Field Cardiac MRI: A Compelling Case for CMR's Future The prospect for excellent field homogeneity, in absolute terms, and virtually no limits imposed by Specific Absorption Rate (SAR) may open up the potential for ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1097664723000364

Diagnostic accuracy of whole heart coronary magnetic ... The purpose of this meta-analysis was to comprehensively investigate the diagnostic ability of 1.5 T and 3.0 T whole heart coronary angiography ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jmri.28890

Cardiac MRI at Low Field Strengths - Campbell‐Washburn In this review, we discuss the recent progress in low-field cardiac MRI with a focus on technical developments and early clinical validation studies.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1050173821000852

Magnetic resonance imaging safety in patients with cardiac ... In this review, we discuss the current evidence regarding MRI in patients with implantable cardiac devices, and highlight questions and controversies that ...

7. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.107.187256

Safety of Magnetic Resonance Imaging in Patients With ... The dosimetric term used to characterize RF energy is the specific absorption rate (SAR, measured in watts per kilogram). SAR increases with the ...

8. jacc.org jacc.org/doi/10.1016/j.jcmg.2018.09.030

CMR and CT of the Patient With Cardiac Devices In this review summarizes the safety issues regarding imaging in patients with cardiac devices. Optimization strategies to mitigate image artifacts and to ...