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

Trial Summary

What is the purpose of this trial?

Background: Magnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs. Researchers want to find better MRI methods and new ways of imaging cardiovascular disease and better understand normal and abnormal cardiovascular and brain function. Researchers are also interested in seeing if gadolinium, the commonly used MRI contrast agent, stays in the body long after the MRI was performed. Objectives: To develop new methods for imaging the heart and other organs of the body. To describe cardiovascular diseases using newer MRI methods To look at the relationship between cardiovascular disease and cardiovascular risk factors and other organ systems To look for gadolinium deposits in the brain from prior exams. Eligibility: Healthy people and people with known or suspected cardiovascular disease ages 7 and older may be eligible for this study. Researchers may be particularly interested in those who: * Have suspected or known cardiovascular disease * Were previously exposed to a gadolinium-based contrast agent, * Need to have a heart MRI scheduled * Need a test of the heart or other body part or will be undergoing a future cardiac catheterization Design: There are multiple arms to the study with optional components; therefore, there are multiple variations as to what an individual participant s experience may involve. Participants will have an MRI scan lasting up to 2 hours. The scanner is a large hollow tube. During the scan, there may be loud knocking and buzzing sounds caused by the scanner. Participants will lie on a table that slides in and out of the tube. Their vital signs may be monitored. Participants may have a test of heart electrical activity using wires connected to pads on the skin. Participants may have blood drawn. Participants may be injected with an MRI contrast agent through a plastic tube inserted in the arm.

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 data supports the effectiveness of the treatment Cardiovascular Magnetic Resonance (CMR) Imaging for cardiovascular disease?

Cardiovascular magnetic resonance (CMR) imaging is a versatile tool that helps in evaluating and managing various heart diseases by providing detailed images of the heart's structure and function. It is non-invasive, does not use radiation, and is effective in diagnosing conditions like cardiomyopathy, myocarditis, and heart tumors, making it a reliable method for assessing heart health. ^{1 2 3 4 5}

Is cardiovascular magnetic resonance imaging (CMR) safe for humans?

Cardiovascular magnetic resonance imaging (CMR) is generally considered safe as it is a non-invasive technique that does not use ionizing radiation. However, certain metal and electronic devices may not be safe during the procedure, and some patients may experience discomfort due to claustrophobia or difficulty holding their breath. Additionally, the use of contrast agents can have potential side effects, so it's important to discuss any concerns with your doctor. ^{2 3 6 7 8}

How is Cardiovascular Magnetic Resonance Imaging different from other treatments for cardiovascular disease?

Cardiovascular Magnetic Resonance Imaging (CMR) is unique because it is a non-invasive method that provides detailed images of the heart without using radiation, making it safe for repeated use. It offers comprehensive insights into heart function, structure, and blood flow, which can help in diagnosing and monitoring cardiovascular diseases more effectively than some other imaging techniques. ^{1 2 9 10 11}

Research Team

W. Patricia Bandettini, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 (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) 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]

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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Introduction to Cardiovascular Magnetic Resonance: Technical Principles and Clinical Applications. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Current variables, definitions and endpoints of the European cardiovascular magnetic resonance registry. [2021]

4. Poland pubmed.ncbi.nlm.nih.gov

The usefulness of cardiovascular magnetic resonance imaging in children with myocardial diseases. [2017]

5. United States 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). [2023]

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

Clinical safety and performance of a MRI conditional pacing system in patients undergoing cardiac MRI. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. [2021]

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

Role of cardiovascular magnetic resonance in acute and chronic ischemic heart disease. [2018]

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

MRI for physiology and function: technical advances in MRI of congenital heart disease. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Cardiac magnetic resonance imaging: current status and future directions. [2013]

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

Cardiac MRI: technical basis. [2020]