Advanced MRI Techniques for Cardiovascular Disease

Recruiting in Palo Alto (17 mi)

Overseen by W. Patricia Bandettini, M.D.

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Disqualifiers: Pregnancy, Breastfeeding, Cardiac devices, others

No Placebo Group

Approved in 6 Jurisdictions

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}

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

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, eGFR < 60 mL/min/1.73m^2 using the 2021 CKD-EPI equation 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, Pregnancy. When uncertain of pregnancy status, subjects will undergo serum or urine pregnancy testing within the 7 days prior to the examination. Among those subjects who will receive MRI contrast , subjects of child-bearing potential will under serum or urine pregnancy testing within 7 days of the day prior to 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, If receiving contrast, children and breast feeding women (unless subject is willing to discard breast milk for 24 hours) are excluded, Healthy volunteer children will not have contrast, In a years time, healthy volunteers are not restricted as to the number of non-contrast MRI examinations they undergo, but they may not undergo more than two examinations involving gadolinium-based contrast agents (GBCA) and those exposures will be at least 18 hours (12 half-ives) apart

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

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

National Institutes of Health Clinical Center Bethesda, MD

Who Is Running the Clinical Trial?

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

National Institute of Mental Health (NIMH) Collaborator

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] Cardiovascular magnetic resonance (CMR) imaging has emerged as a versatile tool for evaluating and managing a variety of cardiovascular diseases [...].

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

Introduction to Cardiovascular Magnetic Resonance: Technical Principles and Clinical Applications. [2020] Cardiovascular magnetic resonance (CMR) is a set of magnetic resonance imaging (MRI) techniques designed to assess cardiovascular morphology, ventricular function, myocardial perfusion, tissue characterization, flow quantification and coronary artery disease. Since MRI is a non-invasive tool and free of radiation, it is suitable for longitudinal monitoring of treatment effect and follow-up of disease progress. Compared to MRI of other body parts, CMR faces specific challenges from cardiac and respiratory motion. Therefore, CMR requires synchronous cardiac and respiratory gating or breath-holding techniques to overcome motion artifacts. This article will review the basic principles of MRI and introduce the CMR techniques that can be optimized for enhanced clinical assessment.

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

Current variables, definitions and endpoints of the European cardiovascular magnetic resonance registry. [2021] Cardiovascular magnetic resonance (CMR) is increasingly used in daily clinical practice. However, little is known about its clinical utility such as image quality, safety and impact on patient management. In addition, there is limited information about the potential of CMR to acquire prognostic information.

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

The usefulness of cardiovascular magnetic resonance imaging in children with myocardial diseases. [2017] Cardiovascular magnetic resonance (CMR) imaging is a clinically proven and reliable diagnostic method for the assessment of morphology, function, and characteristics of myocardial tissue in patients with myocardial diseases. The use of gadolinium contrast agents has created new diagnostic possibilities for tissue characterisation in patients with suspected or known cardiomyopathy, myocarditis, and cardiac tumours.

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] Cardiovascular magnetic resonance (CMR) has emerged as an accurate diagnostic technique for the evaluation of patients with cardiac disease in the majority of clinical settings, thanks to an established additional diagnostic and prognostic value. This document has been developed by a joined group of experts of the Italian Society of Cardiology (SIC) and Italian Society of Radiology (SIRM) to provide a summary about the current state of technology and clinical applications of CMR, to improve the clinical diagnostic pathways and to promote its inclusion in clinical practice. The writing committee consisted of members and experts of both societies in order to develop a more integrated approach in the field of cardiac imaging. This section 2 will cover myocarditis, pericardial disease, cardiomyopathies and valvular heart disease.

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

Clinical safety and performance of a MRI conditional pacing system in patients undergoing cardiac MRI. [2018] Utilization of cardiac magnetic resonance imaging (cMRI) as an imaging modality in clinical practice is rapidly increasing. More evidence from randomized studies establishing clinical safety and performance of pacing systems in patients undergoing a cMRI scan is needed.

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

Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. [2021] Cardiovascular magnetic resonance (MR) is a multiparametric, non-ionizing, non-invasive imaging technique, which represents the imaging gold standard to study cardiac anatomy, function and tissue characterization. Faced with a wide range of clinical application, in this review we aim to provide a comprehensive guide for clinicians about MR safety, contraindications and image quality. Starting from the physical interactions of the static magnetic fields, gradients and radiofrequencies with the human body, we will describe the most common metal and electronic devices which are allowed (MR-safe), allowed under limited conditions (MR-conditional) or contraindicated (MR-unsafe). Moreover, some conditions potentially affecting image quality and patient comfort will be mentioned, including arrhythmias, claustrophobia, and poor breath-hold capacity. Finally, we will discuss the pharmacodynamics and pharmacokinetics of current gadolinium-based contrast agents, their contraindications and their potential acute and chronic adverse effects, as well as the safety issue concerning the use of vasodilating/inotropic agents in stress cardiac MR.

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

Role of cardiovascular magnetic resonance in acute and chronic ischemic heart disease. [2018] Cardiovascular magnetic resonance (CMR) is a multi-parametric, multi-planar, non-invasive imaging technique, which allows accurate determination of biventricular function and precise myocardial tissue characterization in a one-stop-shop technique, free from the use of ionizing radiations. Though CMR has been increasingly applied over the last two decades in every-day clinical practice, its widest application has been in the assessment of ischemic cardiomyopathy.

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

MRI for physiology and function: technical advances in MRI of congenital heart disease. [2019] Cardiovascular MRI is an active area of research, and the techniques and application are continuing to evolve. We have presented the basic categories of MRI techniques used to image the heart and have shown some examples of advanced techniques applied to the evaluation of congenital heart disease. The reader is referred to other articles for examples of these techniques in clinical practice.

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

Cardiac magnetic resonance imaging: current status and future directions. [2013] Cardiac MRI (CMR) provides a comprehensive evaluation of cardiac function and anatomy, as well as myocardial tissue characterization and perfusion. New data show the potential for CMR to analyze left ventricular diastolic function, coronary plaque and myocardial oxygen levels. A growing body of animal and clinical data on molecular imaging, hybrid imaging and interventional CMR holds promise for more widespread clinical application. Technological advances in body coils, 3-T systems, imaging sequences and novel applications such as T1 mapping will expand the application and quality of CMR.

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

Cardiac MRI: technical basis. [2020] Cardiac magnetic resonance (CMR) imaging is an effective method for noninvasively imaging the heart which in the last two decades impressively enhanced spatial and temporal resolution and imaging speed, broadening its spectrum of applications in cardiovascular disease. CMR imaging techniques are designed to noninvasively assess cardiovascular morphology, ventricular function, myocardial perfusion, tissue characterization, flow quantification and coronary artery disease. These intrinsic features yield CMR suitable for diagnosis, follow-up and longitudinal monitoring after treatment of cardiovascular diseases. The aim of this paper is to review the technical basis of CMR, from cardiac imaging planes to cardiac imaging sequences.