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?

The primary aim of this study is to establish the practicality of using two novel imaging modalities for the assessment of biomechanical properties of the aorta.

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.

Is ECG-gated MRA safe for humans?

Research indicates that magnetic resonance imaging (MRI), including ECG-gated MRA, is generally safe for humans, even those with cardiovascular devices, as long as specific conditions and recommendations are followed to minimize risks. ^{1 2 3 4 5}

How does the imaging treatment for aortic aneurysm differ from other treatments?

The imaging treatment for aortic aneurysm using MRI, particularly contrast-enhanced MR angiography (CE-MRA), is unique because it is a noninvasive technique that combines conventional imaging with the acquisition of physiological parameters and 3D-angiography, providing detailed images of the aorta without the need for invasive procedures. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment ECG-gated MRA for aortic aneurysm?

Research shows that ECG-gated MR angiography improves the quality and reproducibility of aortic measurements, which can be crucial for accurate diagnosis and monitoring of aortic aneurysms. This technique provides clearer images by reducing the effects of heart motion, making it a reliable tool for assessing the heart and blood vessels. ^{2 5 6 7 11}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

ECG-gated MR angiography provides better reproducibility for standard aortic measurements. [2021]

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

Cardiac abnormalities: assessment with T2-weighted turbo spin-echo MR imaging with electrocardiogram gating at 0.5 T. [2004]

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

Cardiac magnetic resonance imaging in normal dogs and two dogs with heart base tumor. [2019]

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

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

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

Doppler US gating of cardiac MR imaging. [2019]

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

Electrocardiographic Pad for Efficient Cardiac MR Gating. [2016]

7. Spain pubmed.ncbi.nlm.nih.gov

Magnetic resonance in patients with cardiovascular devices. SEC-GT CRMTC/SEC-Heart Rhythm Association/SERAM/SEICAT consensus document. [2023]

8. Spain pubmed.ncbi.nlm.nih.gov

Magnetic resonance in patients with cardiovascular devices. SEC-GT CRMTC/SEC-Heart Rhythm Association/SERAM/SEICAT consensus document. [2023]

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

Cardiac magnetic resonance imaging: the Massachusetts General Hospital experience. [2015]

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

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

11. Germany pubmed.ncbi.nlm.nih.gov

[MR imaging and MR angiography of the aorta]. [2022]