Evaluation of Myocardial Infarction by Cardiovascular Magnetic Resonance at 0.55-T Compared to 1.5-T.
W Patricia Bandettini, Sujata M Shanbhag, Christine Mancini...
https://pubmed.ncbi.nlm.nih.gov/34023254/Actively Recruiting
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-07-31
2950
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating a new type of magnetic resonance imaging MRI scanner that uses lower energy levels than conventional MRI machines. This low specific absorption rate SAR scanner aims to produce high-quality images of the heart and other organs while reducing heating of metal implants. The study includes healthy adults and adults with known heart or non-heart diseases to test the safety and accuracy of this new MRI technology. Participants will undergo MRI scans using the new low SAR system, and some will also have scans with a conventional MRI for comparison. Scans may include the use of gadolinium dye to enhance image quality and a vasodilator drug to assess blood flow in the heart. The scanning process involves lying inside the MRI machine for up to two hours, holding breath for short periods, and using sensors to monitor heart and breathing activity. During the study, participants will have blood tests and multiple MRI sessions within 60 days if both scanner types are used. The research team will measure the technical feasibility and image quality of the new MRI compared to standard MRI. The study will also monitor participants for safety and collect various health information over a period of up to 72 months to assess the long-term performance of the low SAR MRI system.
CONDITIONS
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
A
Anastasia Tsakirellis, C.R.N.P.
M
Marcus Y Chen, M.D.
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National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Low SAR CMR Imaging | Conventional Clinical MRI |
|---|---|---|
| What it is | An investigational cardiovascular MRI scanner designed to operate at lower specific absorption rate (SAR), enabling potentially safer imaging for patients with implanted electronic devices and those at risk from higher MRI energy levels. | A standard clinical MRI scanner (typically 1.5 Tesla) used routinely for cardiovascular, neurological, musculoskeletal, abdominal, and pulmonary imaging in clinical practice. |
| Role in trial | Assessed as the investigational diagnostic approach for protocol optimization and technical or diagnostic feasibility; all eligible participants undergo imaging with this scanner. | Serves as the protocol-defined reference standard and comparator in this diagnostic accuracy study, reflecting the current clinical pathway. |
| Primary use | Intended to provide diagnostic cardiovascular and whole-body MRI imaging while reducing radiofrequency energy absorption, with a focus on safety in patients with implantable cardiac devices or contraindications to conventional MRI. | Provides diagnostic MRI images for routine assessment of the heart and other organs, commonly used in standard clinical care. |
| How it is performed | Participants lie in the investigational low SAR MRI scanner for advanced cardiovascular or whole-body imaging, with some exams including intravenous gadolinium contrast. The scan aims to minimize radiofrequency energy delivered to the body, and permits imaging of select subjects who would be ineligible for conventional MRI. | Participants undergo a standard clinical MRI exam in a 1.5T or comparable scanner, with protocols following standard clinical safety and imaging procedures, including contrast when appropriate. |
| Evidence status | Technical feasibility and diagnostic image quality of low SAR 0.55T CMR are being evaluated in healthy volunteers and patients. Recent studies have shown promising results for myocardial, cardiac function, and multi-organ imaging but further large-scale clinical validation is underway. | Extensive published clinical evidence supports the diagnostic efficacy of standard clinical MRI (1.5T) across cardiovascular, neurological, musculoskeletal, abdominal, and pulmonary imaging. Considered the clinical reference standard in these settings. |
| Important limitations | Currently investigational, with diagnostic accuracy, image quality, and workflow in diverse disease populations still under research. Some sequences and technical optimizations may not match the breadth and routine usability of mature clinical MRI platforms. | Standard clinical MRI at higher magnetic field strengths may exclude patients with non-MRI-conditional cardiac devices, certain implants, or specific contraindications due to higher radiofrequency energy deposition (SAR). |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 hours per scan, with multiple scans within 60 days if applicable
Participants undergo MRI scans using the new low SAR scanner, and some also have conventional MRI scans within 60 days. Scans may include use of contrast dye and monitoring of heart and breathing functions during the procedure.
1 to 2 visits depending on study group
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/32423456/National Heart, Lung, and Blood Institute (NHLBI)
Lead Sponsor