Advanced MRI Techniques for Cardiovascular Disease

Overseen By W. Patricia Bandettini, M.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Pregnancy, Breastfeeding, Cardiac devices, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve MRI methods for diagnosing and understanding cardiovascular disease. Researchers are exploring ways to better image the heart and other organs, understand the link between heart disease and other risk factors, and determine if MRI contrast dye remains in the body over time. People with known or suspected heart disease or those who have had an MRI with contrast dye may be suitable for this study. Participants will undergo an MRI scan, and some may have their heart activity monitored or blood drawn. As an unphased study, this trial offers participants the chance to contribute to advancements in cardiovascular imaging techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these advanced MRI techniques are safe for cardiovascular imaging?

Research shows that cardiovascular magnetic resonance (CMR) imaging is generally safe and painless for most people. It uses strong magnets and radio waves to capture images of the heart and other organs. Studies have found that individuals with metal devices in their bodies should exercise caution, but those without such implants usually experience no issues during the scan.

CMR imaging is known for its accuracy in assessing heart function and detecting heart disease. While the loud noises and confined space of an MRI may be familiar, they do not pose safety risks. For those who receive a contrast dye during the scan, this substance is usually well-tolerated. However, researchers are investigating whether this dye remains in the body longer than expected, particularly in the brain.

Overall, CMR is considered safe, especially when proper guidelines are followed. For those considering participation in a clinical trial involving CMR, the procedure is well-established and reliable for evaluating heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using advanced Cardiovascular Magnetic Resonance (CMR) Imaging for cardiovascular disease because it offers a non-invasive way to get a detailed view of the heart and blood vessels. Unlike traditional methods like echocardiograms or stress tests, CMR can provide more precise information about heart tissue and function without the need for radiation. This technique could lead to earlier and more accurate diagnoses, helping doctors tailor treatments more effectively for patients.

What evidence suggests that these advanced MRI techniques could be effective for cardiovascular disease?

Research has shown that Cardiovascular Magnetic Resonance (CMR) Imaging effectively diagnoses and evaluates heart diseases. Studies indicate that CMR influences treatment decisions in 71% of patients, aiding doctors in selecting optimal treatments. CMR is regarded as the best method for assessing heart function and identifying structural issues. It provides precise measurements of heart size and pumping efficiency, crucial for diagnosing various heart conditions. Additionally, CMR detects changes in blood flow, making it valuable for understanding both heart and brain functions. ^{2 3 6 7 8}

Who Is on the Research Team?

W. Patricia Bandettini, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for people aged 7 and older, both healthy individuals and those with known or suspected cardiovascular disease. Participants must be able to lie still in an MRI scanner, follow instructions, provide informed consent (or have a guardian do so), and commit to the study procedures. Those previously exposed to gadolinium-based contrast agents or needing heart MRIs may also be of particular interest.

Inclusion Criteria

I have a known or suspected heart condition.

I can follow instructions and stay still during an MRI scan.

I am 7 years old or older.

Exclusion Criteria

I have a history of serious heart conditions.

Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate form) including: Cardiac pacemaker or implantable defibrillator unless it is labeled safe or conditional for MRI, Cerebral aneurysm clip unless it is labeled safe for MRI, Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI, Any type of ear or cochlear implant unless it is labeled safe for MRI, Ocular foreign body (e.g. metal shavings), Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI, Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe or conditional for MRI, Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to examination. Among those subjects who will receive MRI contrast , subjects of childbearing potential will undergo serum or urine pregnancy testing 7 days prior to the examination. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing, Breast feeding (unless subject is willing to discard breast milk for 24 hours if receiving contrast), eGFR < 30 mL/min/1.73m^2 using the 2021 CKD-EPI equation or Community Practice Standard for Pediatric case or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents, Cardiorespiratory instability as determined by the enrolling clinician

Conditions that are thought to make MRI unsafe (that will be determined by filling out a separate screening form) including: Cardiac pacemaker or implantable defibrillator unless it is labeled safe or conditional for MRI, Cerebral aneurysm clip unless it is labeled safe for MRI, Neural stimulator (e.g. TENS-Unit) unless it is labeled safe for MRI, Any type of ear or cochlear implant unless it is labeled safe for MRI, Ocular foreign body (e.g. metal shavings), Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI, Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe or conditional for MRI, Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to examination. Among those subjects who will receive MRI contrast , subjects of childbearing potential will undergo serum or urine pregnancy testing on the day of the examination. In addition, the subject will be asked if she may be pregnant prior to the performance of the MRI, even if the pregnancy test was negative within the past week. The pregnancy test will be repeated if she answers in the affirmative. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing, Breast feeding in those subjects receiving contrast (unless subject is willing to discard breast milk for 24 hours), eGFR < 30 mL/min/1.73m^2 using the 2021 CKD-EPI equation14 or equivalent and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents, Cardiorespiratory instability or as determined by the enrolling clinician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Scan

Participants will have an MRI scan lasting up to 2 hours, which may include the use of contrast agents and monitoring of vital signs.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for outcomes and changes in diagnosis following the MRI scan.

Ongoing

Technical Development

Evaluation of new MRI techniques and sequences for cardiovascular imaging, including assessments of image quality and gadolinium deposition.

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• Cardiovascular Magnetic Resonance (CMR) Imaging

Trial Overview The trial aims to develop new MRI methods for imaging the heart and other organs, describe cardiovascular diseases using these methods, examine the link between cardiovascular disease and risk factors affecting other organs, and detect any long-term brain deposits of gadolinium from previous MRIs. It involves up to 2-hour scans with potential monitoring of vital signs.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

MRI

Cardiovascular Magnetic Resonance (CMR) Imaging is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Cardiovascular Magnetic Resonance Imaging for:

• Diagnosis of cardiovascular diseases
• Assessment of heart structure and function
• Evaluation of congenital heart malformations

Approved in United States as Cardiovascular Magnetic Resonance Imaging for:

• Diagnosis of cardiovascular diseases
• Assessment of heart structure and function
• Evaluation of congenital heart malformations
• Pre-operative planning and post-operative evaluation

Approved in Canada as Cardiovascular Magnetic Resonance Imaging for:

• Diagnosis of cardiovascular diseases
• Assessment of heart structure and function
• Evaluation of congenital heart malformations

Approved in Japan as Cardiovascular Magnetic Resonance Imaging for:

• Diagnosis of cardiovascular diseases
• Assessment of heart structure and function
• Evaluation of congenital heart malformations

Approved in China as Cardiovascular Magnetic Resonance Imaging for:

• Diagnosis of cardiovascular diseases
• Assessment of heart structure and function
• Evaluation of congenital heart malformations

Approved in Switzerland as Cardiovascular Magnetic Resonance Imaging for:

• Diagnosis of cardiovascular diseases
• Assessment of heart structure and function
• Evaluation of congenital heart malformations

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Cardiovascular magnetic resonance (CMR) is recognized as a highly accurate diagnostic tool for assessing various cardiac diseases, providing significant additional diagnostic and prognostic information in clinical settings.

A collaborative effort by experts from the Italian Society of Cardiology and the Italian Society of Radiology aims to enhance the use of CMR in clinical practice, focusing on conditions like myocarditis, pericardial disease, cardiomyopathies, and valvular heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appropriate use criteria for cardiovascular MRI: SIC - SIRM position paper Part 2 (myocarditis, pericardial disease, cardiomyopathies and valvular heart disease). Francone, M., Aquaro, GD., Barison, A., et al.[2023]

Cardiac magnetic resonance (CMR) imaging is a highly effective noninvasive technique that has significantly improved in resolution and speed over the last two decades, making it valuable for diagnosing and monitoring cardiovascular diseases.

CMR can assess various aspects of heart health, including morphology, function, perfusion, and tissue characterization, which supports its use in both diagnosis and follow-up after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac MRI: technical basis. Russo, V., Lovato, L., Ligabue, G.[2020]

Cardiac MRI (CMR) is a powerful tool that not only evaluates heart function and structure but also assesses diastolic function, coronary plaque, and myocardial oxygen levels, enhancing its diagnostic capabilities.

Recent technological advancements, including improved imaging systems and techniques like T1 mapping, are expected to broaden the clinical applications of CMR, making it more effective in diagnosing and managing heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac magnetic resonance imaging: current status and future directions. Cannan, C., Friedrich, MG.[2013]

Cardiovascular magnetic resonance (CMR) is a non-invasive imaging technique that effectively assesses various aspects of heart health, including morphology, function, and blood flow, making it suitable for monitoring treatment effects and disease progression without exposing patients to radiation.

CMR faces unique challenges due to heart and lung movement, requiring advanced techniques like cardiac and respiratory gating to minimize motion artifacts, which is crucial for accurate clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to Cardiovascular Magnetic Resonance: Technical Principles and Clinical Applications. Tseng, WY., Su, MY., Tseng, YH.[2020]

Cardiovascular magnetic resonance (CMR) imaging is highly effective in diagnosing myocardial diseases in children, confirming echocardiographic diagnoses of hypertrophic cardiomyopathy (HCM) in 92% of cases and revealing myocardial fibrosis in 60% of HCM patients.

CMR provides critical additional diagnostic information, confirming or ruling out conditions such as myocarditis, dilated cardiomyopathy, and cardiac tumors, making it an essential tool in the clinical assessment of pediatric myocardial diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The usefulness of cardiovascular magnetic resonance imaging in children with myocardial diseases. Ziółkowska, L., Śpiewak, M., Małek, Ł., et al.[2017]

Cardiovascular magnetic resonance (CMR) imaging is a powerful and flexible technique for assessing various cardiovascular diseases, highlighting its growing importance in clinical practice.

CMR provides detailed insights into heart structure and function, aiding in the diagnosis and management of cardiovascular conditions, although specific study details and outcomes were not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Multi-Faceted Utility of Cardiovascular Magnetic Resonance Imaging: Editorial on Special Issue "Advances in Cardiovascular Magnetic Resonance". Lu, M., Sirajuddin, A.[2023]

In a study involving 283 patients with dual-chamber pacemakers, the Accent MRI™ conditional pacing system demonstrated 100% safety with no MRI scan-related complications during cMRI scans at 1.5 Tesla.

There were no significant changes in the device's performance or electrical parameters before and after the MRI, indicating that the Accent MRI™ system is effective and safe for use in patients undergoing cMRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety and performance of a MRI conditional pacing system in patients undergoing cardiac MRI. Ching, CK., Chakraborty, RN., Kler, TS., et al.[2018]

Cardiovascular MRI is a rapidly evolving field with various techniques being developed to improve heart imaging, particularly for conditions like congenital heart disease.

Advanced MRI techniques are being applied to enhance the evaluation of heart conditions, indicating their growing importance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI for physiology and function: technical advances in MRI of congenital heart disease. Haselgrove, JC., Simonetti, O.[2019]

The EuroCMR Registry aims to evaluate the clinical utility of cardiovascular magnetic resonance (CMR) imaging, focusing on image quality, safety, and its impact on patient management across multiple European centers.

This registry will also track patients with suspected coronary artery disease and hypertrophic cardiomyopathy over 12 months to gather important prognostic data, enhancing our understanding of CMR's effectiveness in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current variables, definitions and endpoints of the European cardiovascular magnetic resonance registry. Wagner, A., Bruder, O., Schneider, S., et al.[2021]

Cardiovascular magnetic resonance (MR) is a safe, non-invasive imaging technique that is the gold standard for assessing heart anatomy and function, but it is important to understand the safety and contraindications of various metal and electronic devices in patients undergoing MR.

The review highlights potential factors affecting image quality and patient comfort, such as arrhythmias and claustrophobia, and discusses the safety and side effects of gadolinium-based contrast agents used in MR imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. Barison, A., Baritussio, A., Cipriani, A., et al.[2021]

Cardiovascular magnetic resonance (CMR) is a safe, non-invasive imaging technique that provides detailed information about heart function and tissue characteristics without using ionizing radiation.

CMR has become increasingly important in clinical practice, particularly for assessing ischemic cardiomyopathy, highlighting its efficacy in diagnosing and managing heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of cardiovascular magnetic resonance in acute and chronic ischemic heart disease. Baritussio, A., Scatteia, A., Bucciarelli-Ducci, C.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5439571/

Cardiovascular Magnetic Resonance Imaging ... In this study, CMR was found to affect clinical outcomes in 71% of the patients. These data are similar to the much larger European Registry ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCIMAGING.124.016523

Cardiovascular Magnetic Resonance: Past, Present, and ... This technique has found application in functional brain magnetic resonance imaging, which measures changes in perfusion by alterations in blood ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7225443/

Cardiovascular magnetic resonance imaging for structural ... CMR provides accurate measurements of cardiac volumes and systolic function using cine imaging and myocardial contouring. Steady-state free precession imaging ...

4. nature.com nature.com/articles/s41591-024-02971-2

Screening and diagnosis of cardiovascular disease using ... CMR has been considered the gold standard for assessing cardiac function; its contemporary application encompasses virtually all aspects of CVDs ...

5. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2768916

Outcomes of Cardiovascular Magnetic Resonance Imaging ... This cohort study evaluates the presence of myocardial injury in unselected patients recently recovered from coronavirus disease 2019 ...

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

Safety of Magnetic Resonance Imaging in Patients With ... There are several potential risks associated with MR scanning of specific cardiovascular devices that result from these processes.

7. heart.org heart.org/en/health-topics/heart-attack/diagnosing-a-heart-attack/cardiac-mri

Cardiac Magnetic Resonance Imaging (MRI) A cardiac MRI is a safe and painless test for most people. People with a metal device inside their body shouldn't have a cardiac MRI unless the ...

8. acc.org acc.org/Latest-in-Cardiology/Articles/2024/05/21/10/30/Current-State-of-MRI-With-Cardiac-Devices

Current State of MRI With Cardiac Devices MRI examinations in patients with CIEDs are safe when rigorous protocols are followed regardless of the type of CIED.