Imaging Techniques for Aortic Aneurysm

Overseen By Mauricia Buchanan, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Allergy to IV contrast, Severe kidney dysfunction, Terminal illness, MRI intolerance, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by treatment group

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if two new imaging techniques, ECG-gated MRA (a type of magnetic resonance imaging) and ECHO (a type of ultrasound), can effectively measure the strength and flexibility of the aorta, a major blood vessel. The study includes three groups: one undergoing minimally invasive surgery, one undergoing open surgery, and one under observation, all using these imaging methods. It targets individuals with an aortic aneurysm (an abnormal bulge in the aorta) or those requiring imaging for other reasons. Participants should have a noticeable aortic enlargement or need an aortic scan for surgery preparation. As an unphased trial, this study provides a unique opportunity to advance imaging techniques that could enhance future aortic care.

Will I have to stop taking my current medications?

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

What prior data suggests that these imaging techniques are safe for assessing aortic aneurysms?

Research shows that the imaging methods used in this study, ECG-gated MRA and ECHO, are generally safe and well-tolerated by people.

ECG-gated MRA, a type of magnetic resonance imaging, creates detailed pictures of blood vessels and is especially useful for checking the aorta after surgery. Studies have found that it provides clear images without needing contrast dye or radiation, reducing potential risks.

ECHO, or echocardiography, uses ultrasound to create images of the heart and aorta. It is widely used and considered safe for monitoring the aorta, with very low risk of complications, making it a reliable tool in medical imaging.

Both techniques have a strong safety record, making them good options for participants in studies focused on the aorta. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced imaging techniques, ECG-gated MRA and ECHO, for managing aortic aneurysms. Unlike traditional approaches that rely mainly on CT scans or ultrasounds, these techniques offer real-time, detailed images of the heart and blood vessels, potentially improving diagnosis and monitoring. This trial aims to determine if these imaging methods can enhance outcomes in patients undergoing different interventions, like EVAR, open surgery, or even opting for surveillance without surgical intervention. By using these cutting-edge imaging technologies, researchers hope to better tailor treatments and improve patient care, making the management of aortic aneurysms more precise and less invasive.

What evidence suggests that these imaging techniques are effective for assessing aortic aneurysms?

This trial will compare different imaging techniques for managing aortic aneurysms. Research has shown that ECG-gated MRA, a special type of MRI scan, can produce clearer and more accurate images of the aorta. This technique helps doctors view the aorta more effectively, especially during different phases of the heartbeat, which is crucial for treatment planning. Participants in this trial will undergo ECG-gated MRA imaging combined with either EVAR, open surgery, or as part of a surveillance approach.

ECHO, or ultrasound, effectively checks for aortic aneurysms, which are bulges in blood vessels, in at-risk individuals. This screening has been linked to lower death rates in these patients. Both imaging methods provide vital information about the aorta, leading to better treatment decisions. ^{2 3 5 6 7}

Who Is on the Research Team?

Houssam Farres, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and need aortic imaging or echocardiography, including those with abdominal aortic aneurysms (AAA) that are larger than normal. It's not for those without imaging needs, with IV contrast allergies or severe kidney issues, terminally ill patients, or those unable to undergo MRI.

Inclusion Criteria

I need special heart imaging but don't have an aortic aneurysm.

I need imaging for my heart or aorta for surgery planning or another reason, and I don't have an aortic aneurysm.

My aorta is at least 1.5 times its normal size.

Exclusion Criteria

You have a very serious illness, and doctors think you may have less than 6 months to live.

I cannot have IV contrast due to an allergy or severe kidney issues.

You cannot undergo a magnetic resonance imaging (MRI) scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Work-up

Standard pre-operative work-up including MRA and ECHO, modified to include ECG-gating and 2-Dimensional speckle-tracking ultrasound

4 weeks

Treatment

Participants undergo either no surgery (surveillance), open surgery, or endovascular aneurysm repair (EVAR) with ECHO and ECG-gated MRA imaging

Varies by treatment group

Follow-up

Participants are monitored for 1 year to analyze the relationship between aortic wall properties and clinical outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• ECG-gated MRA
• ECHO

Trial Overview The study tests the feasibility of using two new imaging methods—ECHO and ECG-gated MRA—to measure the biomechanical properties of healthy and aneurysmal aortas in various patients.

How Is the Trial Designed?

Group I: Surgery-EVAR Active Control 2 Interventions

EVAR with ECHO and ECG-gated MRA imaging.

Group II: Surgery-Open Active Control 2 Interventions

Open Surgery with ECHO and ECG-gated MRA imaging.

Group III: Surveillance Active Control 2 Interventions

No Surgery with ECHO and ECG-gated MRA imaging.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The combination of gated cardiac imaging with magnetic resonance parameters provides a powerful noninvasive method for accurately imaging and measuring cardiac structures, enhancing the ability to detect cardiovascular issues.

This technique allows for reproducible serial studies, which can be applied to various cardiac diseases, showcasing its potential for improving diagnosis and monitoring in cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac magnetic resonance imaging: the Massachusetts General Hospital experience. Miller, SW., Brady, TJ., Dinsmore, RE., et al.[2015]

The study demonstrated that a simplified ECG pad design, which does not touch the skin, significantly reduced setup time for cardiac MRI from 444 seconds with standard leads to 296 seconds, making it a more efficient option for patients and healthcare providers.

The ECG pad provided comparable image quality and signal quality to standard leads, with a success rate of 96% in patients, indicating it is a reliable alternative for ECG gating in cardiac imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocardiographic Pad for Efficient Cardiac MR Gating. Thimmappa, ND., Cooper, MA., Nguyen, TD., et al.[2016]

ECG-gated contrast-enhanced MR angiography (CE-MRA) significantly improves image quality and measurement reproducibility of the ascending aorta compared to non-gated CE-MRA, as shown in a study of 53 patients.

The study found that non-gated CE-MRA had high variability in measurements, which could affect clinical decisions, while ECG gating reduced this variability, making it a better option for monitoring aortic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ECG-gated MR angiography provides better reproducibility for standard aortic measurements. Smith, LR., Darty, SN., Jenista, ER., et al.[2021]

The turbo spin-echo (TSE) method for magnetic resonance imaging (MRI) provides high-quality T2-weighted images of the cardiovascular system in a shorter time, making it efficient for diagnosing various heart conditions.

TSE imaging effectively reduces motion artifacts and enhances signal quality, aiding in the detection of tumors, clots, and other cardiovascular issues, thus proving to be a valuable alternative to traditional MRI methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac abnormalities: assessment with T2-weighted turbo spin-echo MR imaging with electrocardiogram gating at 0.5 T. Seelos, KC., von Smekal, A., Vahlensieck, M., et al.[2004]

For diagnosing chronic aortic disease, MRI is generally the preferred imaging technique, providing detailed information about the aorta's condition.

In acute cases, CT scanning is the most effective method for diagnosis, while echocardiography is recommended for patients with ascending aortic disease or related cardiac issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of aortic aneurysms and dissection: CT and MRI. Hartnell, GG.[2022]

Cardiac magnetic resonance imaging (MRI) uses the patient's electrocardiogram to time image acquisition, allowing for detailed evaluation of heart function and structure.

Different imaging techniques, such as spin-echo and gradient reversal, offer trade-offs: spin-echo provides high contrast for blood flow but lower temporal resolution, while gradient reversal offers higher temporal resolution for assessing heart motion but lower contrast, highlighting the importance of choosing the right technique for specific diagnostic needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primer on cardiac magnetic resonance imaging: how to perform the examination. Boxt, LM.[2019]

Contrast-enhanced MR angiography (CE-MRA) is a noninvasive imaging technique that effectively combines traditional imaging with physiological parameter acquisition and 3D-angiography for assessing diseases of the aorta.

CE-MRA is applicable in various aortic conditions, including congenital malformations, acquired diseases, and inflammatory conditions, highlighting its versatility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[MR imaging and MR angiography of the aorta]. Schneider, G., Massmann, A., Altmeyer, K., et al.[2022]

Magnetic resonance imaging (MRI) is now considered a safe first-line imaging option for patients with cardiovascular devices, provided that specific safety protocols are followed.

The document outlines recommendations from multiple Spanish cardiology and radiology societies to ensure that patients with cardiac implantable electronic devices can undergo MRI safely, reflecting a growing body of clinical evidence supporting this practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance in patients with cardiovascular devices. SEC-GT CRMTC/SEC-Heart Rhythm Association/SERAM/SEICAT consensus document. Barreiro-Pérez, M., Cabeza, B., Calvo, D., et al.[2023]

Magnetic resonance imaging (MRI) is now considered a safe first-line imaging option for patients with cardiovascular devices, provided that specific safety protocols are followed.

The document outlines recommendations from multiple Spanish cardiology and radiology societies to ensure that patients with cardiac implantable electronic devices can undergo MRI safely, reflecting a growing body of clinical evidence supporting this practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance in patients with cardiovascular devices. SEC-GT CRMTC/SEC-Heart Rhythm Association/SERAM/SEICAT consensus document. Barreiro-Pérez, M., Cabeza, B., Calvo, D., et al.[2023]

Doppler ultrasound (US) gating can effectively synchronize cardiac magnetic resonance (MR) imaging, using either the motion of the left ventricular wall or the arterial signal from the great vessels, demonstrating a feasible alternative to traditional ECG gating.

While the range-gated Doppler method faced challenges with radiofrequency shielding, the continuous-wave (CW) Doppler approach significantly reduced these issues, suggesting that CW Doppler may be a more reliable option for cardiac imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doppler US gating of cardiac MR imaging. Rubin, JM., Fowlkes, JB., Prince, MR., et al.[2019]

Cardiac-gated MRI and contrast-enhanced magnetic resonance angiography (CE-MRA) are effective imaging techniques for assessing cardiac anatomy and tumors in dogs, providing detailed 2D and 3D images with short acquisition times under anesthesia.

Unlike contrast-enhanced CT angiography, cardiac MRI is safer as it does not involve ionizing radiation or iodinated contrast medium, making it a valuable alternative for specific cardiac evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac magnetic resonance imaging in normal dogs and two dogs with heart base tumor. Mai, W., Weisse, C., Sleeper, MM.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33409772/

ECG-gated MR angiography provides better reproducibility ... Conclusion: ECG-gated CE-MRA resulted in improved reproducibility in aortic root and ascending aortic measurements. These data suggest that ECG- ...

2. ajronline.org ajronline.org/doi/10.2214/AJR.05.1467

Quantitative Analysis of ECG-Gated High-Resolution ... We found that images acquired with the addition of the ECG gating showed a significant increase in sharpness at the level of the ascending thoracic aorta close ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0741521406005465

Conformational changes during the cardiac cycle with ... Dynamic MRA demonstrated significant aortic area changes during the cardiac cycle before and after EVAR at all three measured levels. Pre-EVAR aortic area ...

4. researchgate.net researchgate.net/publication/348287150_ECG-gated_MR_angiography_provides_better_reproducibility_for_standard_aortic_measurements

ECG-gated MR angiography provides better reproducibility ... Key Points • ECG-gated CE-MRA improves the reproducibility and repeatability of measurements of the ascending aorta. • With non-gated CE-MRA, pulsatile motion ...

5. jcmr-online.biomedcentral.com jcmr-online.biomedcentral.com/articles/10.1186/s12968-021-00774-9

Radial self-navigated native magnetic resonance ... In the intraindividual analysis, native-SN-MRA showed a trend towards superior image quality at the aortic root/ascending aorta and the aortic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10237692/

ECG-gated MR angiography at 3T for follow-up after ... ECG-gated MR angiography at 3T yields good image quality for post-operative surveillance after aortic surgery involving the ascending aorta.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0730725X20306512

Self-navigated 3D whole-heart MRA for non-enhanced ... Self-navigated 3D whole-heart MRA enables reliable contrast- and radiation free aortic dilation surveillance without significant difference to standardized CTA.