Low SAR MRI Scans for Coronary Heart Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
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.
12345Is 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.
678910How 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.
35111213Eligibility 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.
+7 more
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.
+10 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment1 Intervention
Group C includes 500 adult subjects of both sexes with known non-cardiovascular disease
Group II: Group BExperimental Treatment1 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 AExperimental Treatment2 Interventions
Group A includes 600 healthy adult volunteers of both sexes with-out known cardiovascular disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
References
[Indications for MRI in coronary disease]. [2016]Magnetic resonance imaging (MRI) has become a useful, even essential, examination in recent years, for the exploration of patients with coronary disease. MRI has several different roles, even though it remains insufficiently requested because insufficiently available. Today it is the reference examination for assessing indicators of ventricular function (volume, ejection fraction, ventricular mass); their prognostic value and importance in determining treatment are well recognized. In the postinfarction period, MRI using late enhancement techniques allows a precise analysis of the extent of necrosis, in terms of segments and transmural involvement. MRI is indicated, especially preoperatively, in cases of ventricular remodeling and its consequences (functional impairment, aneurysms, parietal thrombus). MRI with pharmacological stress may also be used as a tool for detecting myocardial ischemia; in this case, perfusion or first-pass sequences should be used. On the other hand, cardiac MRI for morphologic exploration of the coronary network and measurement of stenosis is not yet routine.
The Role of Cardiovascular Magnetic Resonance Imaging in Heart Failure. [2021]Cardiovascular imaging is key for the assessment of patients with heart failure. Today, cardiovascular magnetic resonance imaging plays an established role in the assessment of patients with suspected and confirmed heart failure syndromes, in particular identifying aetiology. Its role in informing prognosis and guiding decisions around therapy are evolving. Key strengths include its accuracy; reproducibility; unrestricted field of view; lack of radiation; multiple abilities to characterise myocardial tissue, thrombus and scar; as well as unparalleled assessment of left and right ventricular volumes. T2* has an established role in the assessment and follow-up of iron overload cardiomyopathy and a role for T1 in specific therapies for cardiac amyloid and Anderson-Fabry disease is emerging.
Diagnostic performance of stress cardiac magnetic resonance imaging in the detection of coronary artery disease: a meta-analysis. [2022]The purpose of our study was to conduct an evidence-based evaluation of stress cardiac magnetic resonance imaging (MRI) in the diagnosis of coronary artery disease (CAD).
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]The role of magnetic resonance imaging in the diagnosis of ischemic heart disease has great potential impact on patient management, because a number of aspects of ischemic heart disease can be evaluated in one imaging session. High resolution coronary magnetic resonance angiography is currently available, although several technical improvements are awaited to make the technique routinely applicable. A major advance will probably include the availability of magnetic resonance blood pool contrast agents to improve vessel visualization. Contrast media, in combination with either first pass or delayed myocardial scanning, will also play an important role in myocardial perfusion imaging. Functional magnetic resonance assessment of regional and global ventricular function is currently a well-established technique and is considered a new gold standard, which may impact on routine cardiology practice. This review summarizes some of the recent magnetic resonance developments for evaluating various aspects of ischemic heart disease, including magnetic resonance coronary angiography, flow imaging, and imaging of myocardial perfusion and function.
Magnetic Resonance of Coronary Artery Disease in the Elderly. [2019]Coronary artery disease is one of the leading causes of morbidity and mortality in the elderly population. Currently, the work up of coronary artery disease requires an integrated approach utilizing several diagnostic imaging modalities including coronary x-ray angiography, echocardiography, and radionuclide scintigraphy. Magnetic resonance imaging (MRI) for cardiac imaging offers great potential in the work up of ischemic heart disease. MRI allows the evaluation of the coronary arteries, quantitation of coronary flow and flow reserve, and determination of viability of ischemic myocardium. This paper reviews established and future applications of cardiac MRI with special emphasis on ischemic heart disease. (c)1999 by CVRR, Inc.
Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. [2020]Magnetic resonance imaging (MRI) examinations with intravenous (IV) contrast are performed worldwide in routine daily practice. In order to detect and enumerate even rare adverse events (AE) and serious adverse events (SAE), and to relate them with patients' baseline characteristics and diagnostic effectiveness, high quantity sample size is necessary.
Regulating MR Safety Standards. [2021]Magnetic resonance (MR) imaging uses magnetic fields and radio waves to generate an image of the body. Though it is considered safe because it does not emit ionizing radiation, the strong magnetic fields produced by the MR scanner require unique safety considerations. The American College of Radiology (ACR) has provided guidance documents on MR safety since 2002 and recently updated and reorganized these documents into the ACR Manual on MR Safety. This article discusses the physics of MR imaging, the evolution of MR safety recommendations, and MR safety procedures.
Acute myocardial infarction: safety of cardiac MR imaging after percutaneous revascularization with stents. [2007]To retrospectively determine the safety of cardiac magnetic resonance (MR) imaging performed early (
Magnetic resonance imaging of implantable cardiac rhythm devices at 3.0 tesla. [2008]A relaxation of the prohibition of scanning cardiac rhythm device patients is underway, largely because of the growing experience of safe scanning events at 1.5T. Magnetic resonance imaging (MRI) at 3T is becoming more common and may pose a different risk profile and outcome of MRI of cardiac device patients.
Operational safety issues in MRI. [2019]The clinical usefulness of a diagnostic modality is weighed by considering its potential diagnostic benefit against its potential risk for a patient in question. Magnetic resonance imagining appears to offer both high efficacy and safety under most circumstances. Our understanding of the conditions under which MRI is safe and effective has undergone continual refinement with technological advances and clinical experience. The early emphasis on safety issues of MR focussed on consideration of bioeffects of RF and magnetic fields. More recently, hundreds of operating clinical MR sites, performing hundreds of thousands of clinical examinations to date, have provided a greater awareness of operational safety issues. Much of this experience is summarized in device labeling provided by manufacturers of MR devices, summaries prepared by regulatory agencies, and case reports in the medical literature. The purpose of this article is to review a broad range of safety considerations involved in the operation of MR imagers. The discussion is in two parts: (1) a short update of reported incidents and (2) an analysis of safety issues.
MR coronary angiography: 2001 update. [2005]Cardiovascular magnetic resonance (CMR) has developed multiple techniques that have made it possible to overcome the substantial difficulties in imaging coronary arteries. Tortuous small coronary arteries are imaged in 3D-volume data sets. Cardiac motion is reduced by diastolic gating with ultra-fast sequences. Respiration is suppressed by breath-holding or respiratory gating. Signal-to-noise can be increased with contrast agents. In clinical trials CMR has been successfully used to assess coronary artery stenoses, coronary artery bypass grafts, and anomalous coronary arteries. Recent developments in steady state imaging, volume selective imaging with tracking, parallel imaging techniques, vessel wall imaging, and intravascular contrast agents may soon enable CMR of the coronary arteries to become an effective and widespread clinical tool.
Magnetic resonance coronary artery imaging. [2019]Coronary artery imaging with magnetic resonance imaging carries the potential for a noninvasive, essentially risk-free screening test for those at risk for coronary heart disease. Many physiologic and anatomic challenges including cardiac and respiratory motion and the small size, tortuosity, and variable flow characteristics of the coronary arteries hamper effort to achieve this goal. This article reviews the efforts of several research groups to surmount these difficulties through the use of 2D and 3D techniques; spin echo, gradient echo, and ultrafast sequences; saturation pulses; and contrast agents. Promising results have been and continue to be reported although no obvious optimal solution has yet been determined.
Coronary MR angiography. [2019]MR angiography of the coronary arteries became possible in 1991 with the development of a new group of fast MR imaging sequences. Although the role of coronary MR angiography in screening for coronary artery lesions has not yet been established, coronary MR angiography already has been very successful in the detection of coronary artery variants and the imaging of coronary stents and bypass grafts. Variants of these new MR imaging techniques also can quantitate velocity in native coronary arteries. Several generations of coronary MR angiographic techniques exist; all techniques use EKG-triggering. The use of MR contrast agents appears to further improve all techniques. Technical progress and changes in this subfield of cardiac MR imaging have been so fast that large-scale preclinical trials have not been conducted with the majority of the first and second generation coronary MR angiographic pulse sequences as known today. This article reviews the development of these new cardiac MR imaging techniques and the initial successes with clinical application using commercial MR scanners.