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

Trial Summary

What is the purpose of this trial?

Background: Researchers are testing version of a system known as a magnetic resonance imagining (MRI) scanner that uses strong magnetic fields, radio waves and the like to create images of the organs in the body. It uses lower energy levels than other MRI scanners. This may help scan people with metal devices in their body, or in invasive heart procedures using metal tools. Objective: To test a new MRI scanner and software changes to create better pictures. Eligibility: People with disease and healthy volunteers, ages 18 and older. Design: Participants will be screened with blood tests. Participants may have both the new MRI and a conventional MRI or only the new one. If 2 are done, they must be within 60 days. For both MRI versions, participants lie on a table that slides into a large tube. During scans, they will hold their breath for up to 20 seconds at a time. Heart activity will be measured by wires connected to pads on the skin. A flexible belt may be used to monitor their breathing. They will be in the scanner up to 2 hours. Participants can agree to have a dye called gadolinium injected into their arm during the scan. This brightens the pictures. Participants can agree to take a drug called a vasodilator. This helps detect areas of the heart with abnormal blood supply. Scans of the heart are taken before, during, and after they get the medicine. The drug may cause temporary chest pain or shortness of breath. They may get other drugs to relieve these symptoms. Sponsoring Institution: National Heart, Lung, and Blood Institute

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 data supports the effectiveness of the treatment MRI scan 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 flow problems without using radiation, making it a valuable tool for managing coronary heart disease. ^{1 2 3 4 5}

Is MRI generally safe for humans?

MRI is generally considered safe because it does not use ionizing radiation, but it does involve strong magnetic fields that require specific safety measures. The American College of Radiology provides guidelines to ensure safety, and extensive clinical experience has shown that MRI is safe under most circumstances. ^{6 7 8 9 10}

How does the treatment in the Low SAR MRI Scans for Coronary Heart Disease trial differ from other treatments for coronary heart disease?

This treatment is unique because it uses low SAR (specific absorption rate) MRI scans, which are noninvasive and essentially risk-free, to image coronary arteries and assess coronary artery disease. Unlike traditional methods that may involve radiation or invasive procedures, this approach focuses on advanced MRI techniques to overcome challenges like cardiac and respiratory motion, providing a safer and potentially more comfortable option for patients. ^{3 5 11 12 13}

Research Team

Adrienne E Campbell, Ph.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

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 am 18 years old or older.

I have a known heart condition.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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) 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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Indications for MRI in coronary disease]. [2016]

2. England pubmed.ncbi.nlm.nih.gov

The Role of Cardiovascular Magnetic Resonance Imaging in Heart Failure. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Diagnostic performance of stress cardiac magnetic resonance imaging in the detection of coronary artery disease: a meta-analysis. [2022]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Magnetic Resonance of Coronary Artery Disease in the Elderly. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Regulating MR Safety Standards. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Acute myocardial infarction: safety of cardiac MR imaging after percutaneous revascularization with stents. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

Operational safety issues in MRI. [2019]

11. Italy pubmed.ncbi.nlm.nih.gov

MR coronary angiography: 2001 update. [2005]

12. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance coronary artery imaging. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Coronary MR angiography. [2019]